Registration Dossier

Administrative data

Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

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:
TOXNET CCRIS citing this publication (J. TOXICOL. CUTANEOUS. OCUL. TOXICOL. 3(4):357-370, 1984)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: no information on the method
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
ICR
Sex:
female

Administration / exposure

Route of administration:
dermal
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
18 months
Frequency of treatment:
0; 1 MG IN 0.1 ML DISTILLED WATER 2/WK FOR A MEAN TOTAL DOSE OF 121.4 MG
Doses / concentrations
Dose / conc.:
121.4 other: mg
Control animals:
not specified
Positive control:
not specified

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
no effects observed
Relevance of carcinogenic effects / potential:
Negative results for carcinogenicity

Effect levels

Remarks on result:
not measured/tested

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In a 18-month study, basic violet 10 was administered in distilled water 2/week to mice via dermal route for a mean total dose of 121.4 mg. Carcinogenicity potential of the substance was negative.