SAFETY REPORT OF Tan Oil For Camilla of Sweden AB · = 60 kg) and day has been calculated (SED). The SED was low for all ingredients. For ingredients with available NOAEL values a

SAFETY REPORT OF Tan Oil

For Camilla of Sweden AB 2017-03-15

2

Table of content Table of content ............................................................................................................................ 2

Part A: Cosmetic product safety information ............................................................................. 3

1. Quantitative and qualitative composition of the cosmetic product ..................................... 3

2. Physical/chemical characteristics and stability of the cosmetic product ............................ 3

3. Microbiological quality ........................................................................................................ 4

4. Impurities, traces, information about the packaging material ............................................ 4

5. Normal and reasonably foreseeable use ........................................................................... 4

6. Exposure to the cosmetic product ..................................................................................... 4

7. Exposure to the substances .............................................................................................. 5

8. Toxicological profile of the substances .............................................................................. 5

9. Undesirable effects and serious undesirable effects ......................................................... 6

10. Information on the cosmetic product................................................................................ 6

Part B: Cosmetic product safety assessment ............................................................................ 6

1. Assessment conclusion ..................................................................................................... 6

2. Labelled warnings and instructions of use ......................................................................... 6

3. Reasoning .......................................................................................................................... 6

Appendix 1. .......................................................................................................................... 11

3

Part A: Cosmetic product safety information Product: Tan oil Responsible person: Camilla of Sweden AB, Kristineholmsvägen 10F, 441 39 Alingsås, Sweden Manufacturer: Camilla of Sweden AB, Kristineholmsvägen 10F, 441 39 Alingsås, Sweden

1. Quantitative and qualitative composition of the cosmetic product

The raw materials are purchased from Naturkosmetikkompaniet

2. Physical/chemical characteristics and stability of the cosmetic product

Finished product: Product type: Body care oil, which contains beta-carotene that in some studies has shown to give a certain sun protection after repeated use (Köpcke W, Krutmann J. Protection from sunburn with beta-Carotene - a meta-analysis. Photocem Photobiol. 2008 Mar-Apr;84(2):284-8) and also in some studies indicated to give a more attractive tan (Stephen ID, Law Smith MJ, Stirrat MR, Perrett DI. Facial skin coloration affects percieved health of human faces. Int J Primatol. 2009 Dec;30(6):845-857).

Råvara INCI name CAS noContent

(kg)

Conc %

(w/w)

Function in the

product

Jojoba-

olja

Simmondsia

Chinensis Seed

Oil

90045-98-0 4320 47,35 EMOLLIENT

SKIN

CONDITIONING

Tistelolja Carthamus

tinctorius seed

oil

8001-23-8 2766 30,31 SKIN

CONDITIONING

Kokosfett Cocos nucifera

oil

8001-31-8 2000 21,92 SKIN

CONDITIONING

Karotin Daucus carota

root extract

84929-61-3 8,5 0,09 SKIN

CONDITIONING

E-vitamin Tocopherol 10191-41-0 30 0,33 ANTIOXIDANT

SKIN

CONDITIONING

Råvara INCI name CAS noConc %

(w/w)

Purity/

Conc in raw

material

Certificate AdditiviesClassifica

tionRestrictions

Jojoba-

olja

Simmondsia

Chinensis Seed Oil

90045-98-0 47,35 100% Organic

Tistelolja Carthamus tinctorius

seed oil

8001-23-8 30,31 100% Organic

Kokosfett Cocos nucifera oil 8001-31-8 21,92 100% Organic

Karotin Daucus carota root

extract

84929-61-3 0,09 Simmondsia

Chinensis Seed Oil

> 50%

carotene 5 - 1O%

Rosmarlnus

offlcinalls leaf

extract < 0.1%

Carotene: IV/111:

Purity criteria as

set out in

Commission

Directive 95/45/EC

(E 160a)

E-vitamin Tocopherol 10191-41-0 0,33 >97% H317

4

Physical form: Body Oil to be used together with sunscreen product with known sun protection factor to give a more attractive sunburn. Perfume: No Stability: According to the manufacturer the shelf-life of the finished product is at least 6 months.

3. Microbiological quality

The product does not contain water and is therefore classified as low risk products according to ISO 29621. According to the rapport “Hudkrämer och liknande produkter” Tillsynsrapport från enheten för kosmetika och hygienprodukter 2011-04-13 (Reviderad 2011-05-17) from the Swedish medical Agency it is not relevant to perform challenge testing on water free products.

4. Impurities, traces, information about the packaging material

The raw materials are food stuff or certified organic, i.e. the content of impurities has been check by certification bodies. Considering the concentrations of impurities that are expected in food stuff and certified organic raw materials, the concentrations of impurities in the cosmetic product are negligible. The primary packing material is Copolyster EB062 from Eastman. It doesn’t contain any harmful substances and it is intended for use in contact with food stuff.

5. Normal and reasonably foreseeable use

Body oil to be used daily (see below).

6. Exposure to the cosmetic product

a. The site of application: body and head.

b. The surface area of application: 15670 cm2

c. The amount of product applied: 7.82 g/day

d. The duration and frequency of use: 2.28 times/day

e. The normal and reasonably foreseeable exposure route(s): dermal

f. The targeted (or exposed) population(s): Adults

g. Retention factor: 1.0

Exposure: Adult: 7.82 g/60 kg = 130.3 mg/kg/day

5

According to the “SCCS's Notes of Guidance for the testing of cosmetic

substances and their safety evaluation”, 9th Revision

Impact due to particle size (nano): The product contains no nano material

7. Exposure to the substances

See table 3. The amount applied of each ingredient per kg bw (tot body weight = 60 kg) and day has been calculated (SED). The SED was low for all ingredients. For ingredients with available NOAEL values a margin of safety (MOS) have been calculated. As a worst case scenario 100% absorption has been used for all ingredients. Table 3. SED and MOS-values for the ingredients of the product

8. Toxicological profile of the substances

Gathered information is presented in Appendix 1. The following data bases and sources have been consulted for compiling toxicity data for the ingredients: CosIng, http://ec.europa.eu/consumers/cosmetics/cosing/ CIR (Cosmetic Ingredients Review) opinions Bibra, http://www.bibra-information.co.uk/ SCCS (Scientific Committee of Consumer Safety) opinions IUCLID (International Uniformed Chemical Information Database) datasets ECHA (European Chemicals Agency)

EFSA (European Food Safety Authority

INCI name CAS noConc %

(w/w)

SED mg/kg

bw/day at

100%

absorption

Total: 130.3

mg/kg/day

lowest

reported

NOAEL

mg/kg bw

Margin of

Safety

(MOS)/

comments

Simmondsia

Chinensis Seed Oil

90045-98-0 47,43 61,80 Safe

according to

CIR

Carthamus tinctorius

seed oil

8001-23-8 30,31 39,50 Safe

according to

CIR

Cocos nucifera oil 8001-31-8 21,92 28,56 Safe

according to

CIR

Tocopherol 10191-41-0 0,33 0,43 Safe

according to

CIR

Beta-Carotene 7235-40-7 0,01 0,01 GRAS

Rosmarlnus offlcinalls

leaf extract

84604-14-8 0,0001 0,0001 300 30000000

6

HERA (Human and Environmental Risk Assessment on ingredients of household cleaning products)

HSDB (Hazardous Substances Databank)

Toxline, database

SIDS (Screening Information Dataset)

EPA (United States Environmental Protection Agency)

FDA (United States Food and Drug Administration)

INCHEM (International Program on Chemical safety)

NICNAS (National Industrial Chemicals Notification and Assessment Scheme, Australian Government Department of Health and Ageing)

C&L (Classification and Labeling) inventory

CosmeticsINFO http://www.cosmeticsinfo.org/

PubMed http://www.ncbi.nlm.nih.gov/pubmed

9. Undesirable effects and serious undesirable effects

Responsible person has set up a system to collect document, establish causality and manage the undesirable effects caused by the product.

10. Information on the cosmetic product

No additional information.

Part B: Cosmetic product safety assessment

1. Assessment conclusion

Based on the information provided by the manufacturer and the toxicity data compiled for the ingredients, it can be concluded that the Tan Oil is unlikely to produce abnormally high number of adverse effects if used according to instructions and under normal or reasonably foreseeable conditions of use. The product will give users the level of safety that can reasonably be expected.

2. Labelled warnings and instructions of use

För en vackrare solbränna och ett effektivt skydd mot solen använd Tan oil tillsammans med solskyddsmedel med önskad solskyddsfaktor.

3. Reasoning

The Tan Oil is a body oil that contains well-known ingredients extensively used in different cosmetic products. The Tan Oil is a body care oil, which contains beta-carotene that in some studies has shown to give a certain sun protection after repeated use (Köpcke W, Krutmann J. Protection from sunburn with beta-Carotene - a meta-analysis. Photocem Photobiol. 2008 Mar-Apr;84(2):284-8) and also in some studies indicated to give a more attractive tan (Stephen ID, Law Smith MJ, Stirrat MR, Perrett DI. Facial skin coloration affects percieved health of human faces. Int J Primatol. 2009 Dec;30(6):845-857). However, since the sun protection factor (SFP) of the product has not been established in a test, it should be indicated

http://www.cosmeticsinfo.org/

7

on the product that it should be used as a complement to other sun protection products with established SPFs.

The complied toxicity data on the ingredients do not indicate any specific worries for any of the ingredients (Table 1, Part B). The concentration of beta-carotene is low in the product (0.01%) and is therefore of no concern.

The product does not contain water and is therefore classified as low risk products according to ISO 29621, i.e. challenge testing is not needed. Information on packaging material has been provided. It doesn’t contain any harmful substances. Interaction between the primary packaging material and the product is not expected. The raw material is mainly certified organic, i.e. the content of impurities has been check by certification bodies. Considering the concentrations of impurities that are expected in certified organic raw materials, the concentrations of impurities in the cosmetic product are negligible. The manufacturing of the product should follow a quality controlled standardised procedure.

The SED was calculated for all ingredients and MOS was calculated for the ingredient with available NOAEL value. The calculated MOS value for Rosmarinus offlcinalis leaf extract was over 100, i.e. no reason for concern. The ingredients without NOAEL values were classified as GRAS or considered safe by CIR. Table 1, Part B

INCI name CAS noConc %

(w/w)

SED mg/kg

bw/day at

100%

absorption

Total: 130.3

mg/kg/day

lowest

reported

NOAEL

mg/kg bw

Margin of

Safety

(MOS)/

comments

Simmondsia

Chinensis Seed Oil

90045-98-0 47,43 61,80 Safe

according to

CIR

Carthamus tinctorius

seed oil

8001-23-8 30,31 39,50 Safe

according to

CIR

Cocos nucifera oil 8001-31-8 21,92 28,56 Safe

according to

CIR

Tocopherol 10191-41-0 0,33 0,43 Safe

according to

CIR

Beta-Carotene 7235-40-7 0,01 0,01 GRAS

Rosmarinus offlcinalls

leaf extract

84604-14-8 0,0001 0,0001 300 30000000

8

Danderyd 2017-03-15

Cecilia Clemedson, Ph.D., ERT AdvocoTox AB Danderyds Campus, Mörby Centrum, plan 7 SE-182 31 Danderyd, Sweden www.advocotox.se [email protected] Mobile +46(0)70 601 91 89

mailto:[email protected]

9

CURRICULUM VITAE

of Cecilia Clemedson

Title Ph. D. in Toxicology, ERT Birthplace Danderyd, Sweden Date of birth November 30, 1960 Business address: AdvocoTox AB, Danderyds Campus Mörby Centrum, plan 7 SE-182 31 Danderyd, Sweden Mobile +46-70-601 91 89 E-mail [email protected] ACADEMIC EXAMINATIONS 1985 Bachelor of Science, microbiology, molecular biology, and chemistry, University of Uppsala. 1989 Licentiate of Philosophy, Department of Neurochemistry and Neurotoxicology, University of Stockholm. 1992 Doctoral Thesis at Department of Neurochemistry and Neurotoxicology, University of Stockholm. 2015 European Registered Toxicologist EDUCATION 1980 Course in ecology and environmental technology, 7 weeks, Royal

Technical High School (KTH), Stockholm. 1985 Course in Toxicology, 20 weeks, Karolinska Institutet, Stockholm. 1987 Course in ”Ion channels: structure, function and the methodology to study them”, 5 weeks, University of Stockholm. 1989 Course in ”The structure and function of the nervous system”, 7 weeks,

Karolinska Institutet, Stockholm. 1989 Course in Scientific Writing, University of Stockholm. 1990 Course in ”Reproductive toxicology”, Karolinska Institutet, Stockholm. 1991 Course in ”Neurotoxicology”, Karolinska Institutet, Stockholm. 1999 Course in ”Toxicokinetics”, Karolinska Institutet, Stockholm. 1999 Course in Principles, practices and problems in preparing The

Toxicological Expert Report, Pre-clinical and regulatory perspectives, Management Forum, London, UK.

2000 Course in ”Drug toxicology”, Karolinska Institutet, Stockholm.

10

POSITIONS IN THE PROFESSION 1980-1982 Trainee at the Dept. of Neurochemistry & Neurotoxicology, University of

Stockholm. 1986-1992 Ph.D. student at the Dept. of Neurochemistry & Neurotoxicology,

University of Stockholm. 1992-1995 Programme Secretary of the MEIC programme, Department of

Pharmaceutical Biosciences, Division of Toxicology 1995-1997 Maternal leave 1997-2000 Managing director of NICA-Nordic Information Centre for Alternative

Methods, Stocksund, Sweden 1997- Managing director of CCTox Consulting, Stocksund, Sweden 2001-2010 Part owner of Expertrådet ECB Miljökompetens AB, Sollentuna, Sweden 2001- 2009 Board member of Expertrådet ECB Miljökompetens AB, Sollentuna,

Sweden 2001-2005 Coordinator of the EDIT programme 2005- 2010 Scientific Coordinator of ACuteTox, an Integrated Project under the

EU6FP. 2007-2009 Coordinator of Forinvitox, a project under the EU6FP 2009- Managing director and part owner of AdvocoTox AB, Danderyd, Sweden

11

Appendix 1.

Beta-carotene CAS NO 7235-40-7

1. Acute toxicity

No toxic effects were seen when rats, mice, hamsters and dogs were fed repeated high

doses of beta-carotene (Bibra 1991).

2. Skin irritation and corrosivity

No data available

3. Eye irritation

beta-Carotene produced transient irritation in the eye of rabbits (Bibra 1991).

4. Skin sensitisation

No data available

5. Dermal/percutaneous absorption

No data available

6. Repeated dose toxicity

No data available

7. Mutagenicity/genotoxicity

Beta-Carotene was not mutagenic in the Ames bacterial test and did not induce

chromosomal damage when fed to mice. Equivocal results have been reported in tests for

DNA damage in bacteria (Bibra 1991).

8. Carcinogenicity

Epidemiological studies have provided fairly convincing support for a link between low dietary

or blood levels of beta-carotene and a higher lung cancer risk. Protection against other

cancer types has been less clearly demonstrated in man. beta-Carotene provoked a

recurrence of symptoms when ingested by patients with dermatitis and one individual

exhibited a skin reaction following local contact. Lifetime feeding studies gave no evidence of

carcinogenicity in rats and mice (Bibra 1991).

9. Reproductive toxicity

Two multi-generation feeding studies in rats revealed no adverse effects, but mild depression

of pup growth and delayed bone development was reported in rat studies in which beta-

carotene was fed to females during pregnancy. No reproductive effects were seen when

pregnant rabbits were given oral doses (Bibra 1991).

10. Endocrine disruptors

No data available

11. Other

Beta-Carotene occurs naturally in the diet. In man, prolonged ingestion of carotene-

containing vegetables or beta-carotene supplements can lead to high levels of beta-carotene

in the body (hypercarotenaemia) and a yellow colouring of the skin. The colouring fades

when dosing is stopped. Whilst there is some indication of subtle influences on the blood, it is

not yet clear whether these can be described as toxic effects (Bibra 1991).

12. Conclusions

The FDA also includes Beta-Carotene on its list of direct food substances Generally

Recognized as Safe (GRAS) (CosmeticsInfo 2017).

13. NOAEL

No data available

12

14. References

Bibra (1991) https://www.bibra-information.co.uk/downloads/toxicity-profile-for-beta-carotene-

1991/

CosmeticsInfo (2017) http://www.cosmeticsinfo.org/ingredient/beta-carotene

13

Carthamus Tinctorius Seed Oil CAS NO 8001-23-8

1. Acute toxicity

No data available


Undiluted Carthamus Tinctorius Seed Oil was minimally irritating in a repeat open patch test

using rabbits. Cosmetic formulations containing 3-5% Carthamus Tinctorius Seed Oil were

not irritating to humans in occlusive patch tests and were not primary irritants in repeated

insult patch tests (CIR 2011).

3. Eye irritation

No data available


Undiluted Carthamus Tinctorius Seed Oil was not a sensitizer in a maximization study using

guinea pigs. Cosmetic formulations containing 3-5% Carthamus Tinctorius Seed Oil were not

sensitizers in repeated insult patch tests (CIR 2011).


No data available


No data available


No data available

8. Carcinogenicity

No data available


No data available


No data available

11. Other

No data available

12. Conclusions

The CIR Expert Panel concluded that the Carthamus Tinctorius Seed Oil is safe to use in

cosmetics (CIR 2011).

13. NOAEL

No data available

14. References

CIR (2011) http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/FR577.pdf

14

Cocos Nucifera Oil CAS NO 8001-31-8

1. Acute toxicity

Administered as a single 5 g/kg dose to rats, cocos nucifera oil did not caused deaths over a

7-day observation period (CIR 1986).


Coconut Oil did not cause skin irritation when applied to rabbit skin in a 24-h single-insult

occlusive patch test. Bar soaps containing 13% Coconut Oil, when tested using standard

Draize procedures, produced very minimal skin reactions. In a 2-week normal use test, bar

soaps caused no unusual irritation response. The results of soap

chamber tests of bar soaps were minimal irritation in one study and mild irritation in another

(CIR 1986).

3. Eye irritation

Results of several studies suggest that the eye irritation potential of Coconut Oil is low (CIR

1986).


Coconut Oil did not cause skin irritation when applied to rabbit skin in a 24-h single-insult

occlusive patch test. It was nonsensitizing to the skin in a Magnusson-

Kligman Maximization test (CIR 1986).


No data available


In subchronic feeding study of diets containing 25% Coconut Oil, rats had slight fatty change

of the liver but no other pathological changes (CIR 1986).


No data available

8. Carcinogenicity

No data available


No data available


No data available

11. Other

No phototoxicity or photosensitivity has een observed (CIR 1986). The Food and Drug

Administration (FDA) permits Coconut Oil to be used as a direct food additive as a substitute

for cocoa butter (CosmeticsINFO 2013).

12. Conclusions

The Cocos Nucifera Oil did not produce significant skin or eye irritation. No sensitization was

reported. Clinical assessment of cosmetics and personal care products containing Coconut

Oil and other coconut oil-derived ingredients produced very minimal skin irritation reactions.

There was no indication that these ingredients were primary irritants, sensitizers, or

phototoxic compounds following human testing. The CIR Expert Panel concluded that Cocos

Nucifera Oil was safe for use in cosmetics and personal care products (CIR 1986).

13. NOAEL

No data available

15

14. References

CosmeticsINFO (2013) http://www.cosmeticsinfo.org/ingredient/coconut-oil-and-related-

ingredients

CIR (1986) http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/pr181.pdf

16

Daucus Carota Sativa Seed Oil CAS NO 8015-88-1 / 84929-61-3

1. Acute toxicity

Not known to be toxic


No data available

3. Eye irritation

No data available


No data available


No data available


No data available


No data available

8. Carcinogenicity

No data available


No data available


No data available

11. Other

No data available

12. Conclusions

No data available

13. NOAEL

No data available

14. References

No data available

15. Notes

No data available

17

HELIANTHUS ANNUUS SEED EXTRACT

CAS NO 84776-03-4 / 8001-21-6

1. Acute toxicity

No data available


Not a skin irritant (CIR 2011).

3. Eye irritation

No data available


Not a skin sensitizer (CIR 2011).


No data available


No data available


No data available

8. Carcinogenicity

No data available


No data available


No data available

11. Other

The FDA includes sunflower seed oil and its triglycerides or fatty acids on its list of indirect

food additives. These ingredients may be used as components of resinous and polymeric

coatings having incidental contact with food (CosmeticsINFO 2014).

12. Conclusions

The CIR Expert Panel has evaluated scientific data of sunflower seed oil and its triglycerides

or fatty acids. Based on a history of safe use in food, the composition of the oils, and data

indicating these ingredients were not dermal irritants or sensitizers, the CIR Expert Panel

concluded that they are safe as used in cosmetic products.

Botanical and botanically derived ingredients used in the formulation of cosmetics are

generally mild and safe. There is a considerable body of information about the safety of

Botanical ingredients and a well established history of use (CosmeticsINFO 2014).

13. NOAEL

No data available

14. References

CosmeticsINFO (2014) http://www.cosmeticsinfo.org/ingredient/helianthus-annuus-sunflower-

seed-oil-and-related-ingredients

http://www.cosmeticsinfo.org/ingredient/helianthus-annuus-sunflower-seed-oil-and-related-ingredients

http://www.cosmeticsinfo.org/ingredient/helianthus-annuus-sunflower-seed-oil-and-related-ingredients

18

Rosmarinus Officinalis Leaf Extract CAS NO 84604-14-8

1. Acute toxicity

The acute toxicity of Rosmarinus officinalis (rosemary)-derived ingredients is not very

remarkable. The dermal LD50 of Rosmarinus officinalis leaf oil is > 10 ml/kg. The oral LD50

of Rosmarinus officinalis leaves is >2 g/kg, of Rosmarinus officinalis leaf extract is >8.5 g/kg,

and of Rosmarinus officinalis leaf oil is 5.5 g/kg (CIR 2013).


An ointment containing 4.4% Rosmarinus officinali leaf oil, applied at concentrations up to

40%, was not irritating to rat skin. However, in a rabbit study, occlusive application to intact

and abraded skin produced moderate irritation. In an in vitro study using the reconstituted

human epidermis model, rosmarinic acid was not predicted

to be irritating. In clinical testing, Rosmarinus officinalis leaves produced irritation in 44 of 234

patients with contact dermatitis or eczema. Rosmarinus officinalis leaf oil, 10% in petrolatum,

was not an irritant in a 48-h closed patch test (CIR 2013).

3. Eye irritation

No data available


Rosmarinus officinalis leaf oil, 10% in petrolatum, was not a sensitizer in a maximization

study. However, several cases of allergic reactions to Rosmarinus officinalis have been

reported (CIR 2013).


In an in vitro transdermal permeation study using full-thickness dorsal rat skin, rosmarinic

acid had good permeability through the skin (CIR 2013).


Doses as high as 14.1 g/kg bw Rosmarinus officinalis leaf extract were tested (5 days by

gavage), and studies were performed for up to 3 months (dietary). Increases in absolute and

relative liver-to-body weights were observed in many of the studies, independent of the

extraction method; these changes were shown to be reversible, and no other signs of toxicity

were observed. Oral administration of Rosmarinus officinalis leaf oil also affected liver

weights. No signs of toxicity were observed when 0.3% rosmarinic acid was fed to mice for 8

wks. In a clinical 21-day study, daily oral treatment with 50 or 200 mg rosmarinic acid did not

produce any adverse effects. The LOEL was 300 mg/kg bw/day s.c. rosmarinic acid (CIR

2013).


Rosmarinus officinalis leaf extract was not genotoxic when tested in vitro in an Ames test, in

a chromosomal aberration assay in human lymphocytes, or in a gene-locus mutation assay in

human lymphocytes, and it was not genotoxic when tested in vivo in a chromosomal

aberration assay or micronucleus test (CIR 2013).

8. Carcinogenicity

No indications of carcinogenicity (CIR 2013).


No indications of reprotoxicity (CIR 2013).


No data available

11. Other

The FDA includes Rosmarinus officinalis on its list of spices and other natural seasonings

and flavorings considered Generally Recognized As Safe (GRAS). Rosmarinus officinalis leaf

19

extract and rosmarinic acid have been shown to have anti-inflammatory activity

(CosmeticsINFO 2014).

12. Conclusions

Botanical and botanically-derived ingredients used in the formulation of cosmetics are

generally mild and safe. There is a considerable body of information about the safety of

botanical ingredients and a well-established history of use (CosmeticsINFO 2014).

13. NOAEL

300

14. References

CosmeticINFO (2014) http://www.cosmeticsinfo.org/ingredient/rosemary-derived-ingredients

CIR (2013) http://www.cir-safety.org/sites/default/files/rosmarinus.pdf

20

Simmondsia Chinensis Seed Oil CAS NO 90045-98-0

1. Acute toxicity

Oral mouse and rat LD50 was greater than 5.0 g/kg (CIR 2008, 1992).


Simmondsia Chinensis (Jojoba) Seed Oil was non- to slightly irritating when instilled into the

eyes of white rabbits (CIR 2008, 1992).

3. Eye irritation

Undiluted Simmondsia Chinensis (Jojoba) Seed Oil was not a skin irritant. Tests of topical

products containing Simmondsia Chinensis (Jojoba) Seed Oil found them to be nonirritants to

humans. (CIR 2008, 1992).


In a maximization test, no sensitization reactions were observed with Jojoba Alcohol. Tests of

topical products containing Simmondsia Chinensis (Jojoba) Seed Oil found them to be

nonsensitizers to humans. Sensitization to undiluted Jojoba Oil was not observed (CIR 2008,

1992).


Based on the large molecular weight of the components of the Jojoba Oil ingredients, the CIR

Expert Panel concluded that they would not penetrate the skin (CIR 2008, 1992).


No data available


Jojoba Alcohol and mixture of Jojoba Oil and Hydrogenated Jojoba Oil were not mutagenic in

bacterial assays (CIR 2008, 1992).

8. Carcinogenicity

No data available


No data available


No data available

11. Other

No data available

12. Conclusions

The CIR Expert Panel evaluated the scientific data and based on the available information

concluded that Jojoba Oil and the related ingredients were safe for use as cosmetic

ingredients (CIR 2008, 1992).

13. NOAEL

No data available

14. References

CIR (2008, 1992) http://online.personalcarecouncil.org/jsp/CIRList.jsp?id=3116

21

Tocopherol CAS NO 54-28-4 / 16698-35-4 / 10191-41-0 / 119-13-1 / 1406-18-4 / 1406-66-2 / 2074-53-5 / 59-02-9 / 7616-22-0

1. Acute toxicity

In rats, the dermal LD50 is >3 g/kg for tocopherol. The oral LD50 of tocopherol greater than 4

g/kg. In mice, the oral LD50 of tocopherol is >25 ml/kg (CIR 2014).


Tocopherol was not an irritant (CIR 2014).

3. Eye irritation

No data available


Tocopherol was not a sensitizer (CIR 2014).


Dermally applied tocopherols do penetrate the skin (CIR 2014).


In rats, tocopherol was not toxic in a 60-day study. In a 90-day study, rats dosed orally with

2000 mg/kg d-α-tocopherol died in 9 to 11 wks because of internal hemorrhage; other signs

of toxicity were observed in a dose-dependent manner. High doses of tocopherol has a

hemorrhagic activity (CIR 2014).


Anti-mutagenic activity attributed to these compounds was consistent with their antioxidant

properties (CIR 2014).

8. Carcinogenicity

Carcingenicity studies were negative (CIR 2014).


Reproductive toxicity studies were negative


No data available

11. Other

The FDA includes Tocopherol on its list of nutrients considered Generally Recognized As

Safe (GRAS). Tocopherol is also on FDA's list of GRAS food preservatives (CosmeticsINFO

2015).

12. Conclusions

The safety of Tocopherol and related ingredients (Dioleyl Tocopheryl Methylsilanol,

Potassium Ascorbyl Tocopheryl Phosphate, Tocophersolan, Tocopheryl Acetate, Tocopheryl

Linoleate, Tocopheryl Linoleate/Oleate, Tocopheryl Nicotinate, Tocopheryl Succinate) has

been assessed by the CIR Expert Panel. The CIR Expert Panel evaluated the scientific data

and concluded that Tocopherol and the related ingredients were safe as used in cosmetics

and personal care products (CIR 2014).

13. NOAEL

No data available

14. References

CosmeticsINFO (2015) http://www.cosmeticsinfo.org/ingredient/tocopherol-and-related-

ingredients

CIR (2014) http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/FR667.pdf

22

23

SAFETY REPORT OF Tan Oil For Camilla of Sweden AB · = 60 kg) and day has been calculated (SED). The SED was low for all ingredients. For ingredients with available NOAEL values a

Documents