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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Based on the limited reporting, the limited number of organs investigated as well as the study design it is not possible to assess the validity of the study.

Data source

Reference
Reference Type:
publication
Title:
Skin Painting Studies in Mice with 14 Fd&c and D&c Colors: Fd&c Blue no. 1, Red No. 3, and Yellow No. 5, D&C Red No. 7, Red No. 9, Red No. 10, Red No. 19, Red No. 21, Red No. 27, Red No. 31, Red No. 36, Orange No. 5, Orange No. 10, and Orange No. 17
Author:
Carson S
Year:
1984
Bibliographic source:
Cutaneous and Ocular Toxicology Vol. 3, No. 4 , Pages 357-370

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
mouse
Sex:
male/female

Administration / exposure

Vehicle:
water
Duration of treatment / exposure:
18 month
Frequency of treatment:
2 times a week
Doses / concentrations
Remarks:
Doses / Concentrations:0.1 mL 1% suspension of test itemBasis:
No. of animals per sex per dose:
50

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 0.05 mg/cm² per day (nominal)
Based on:
test mat.
Sex:
male/female
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

A series of 14 cosmetic colors were submitted to dermal toxicity testing in accordance with a protocol designed by the Food and Drug Administration and agreed upon with the Cosmetic, Toiletry and Fragrance Association (formerly the Toilet Goods Association). Dosage levels were based on lipstick use determinations made in a group of human female volunteers. The groups of lipstick colors were divided into three treatment series and painted on twice weekly to an area approximately 6 cm2. A total of 1400 mice were used comprising groups of 100 mice (50 per sex) plus additional positive control group of the same size and a vehicle control group of 300 mice (150 per sex). All colors were prepared at 1.0% suspensions in water. The positive control received 3.4–benzpyrene dissolved in acetone. Survival was approximately equivalent in all experimental groups except the positive controls who died earlier consistent with survival recorded by others for 3.4–benzpyrene treated mice. Extramedullary hematopoesis was found in all treated groups, equivalent to the findings in the controls. The repeated application of 0.1 ml containing 1.0% dye did not increase the incidence of neoplasia when compared to controls in any of the groups receiving application of the 14 dyes.