Registration Dossier
Registration Dossier
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EC number: 211-199-0 | CAS number: 633-96-5
Carcinogenicity
Administrative data
Description of key information
No adverse reactions or pathological changes were observed following weekly dermal applications for 18 months to the dorsal area of Swiss-Webster.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: FDA and Tolitet Goods Association
- Deviations:
- not specified
- Principles of method if other than guideline:
- The protocol for the series of tests carried out between 1961 and 1969 was agreed on and utilized after direct consultation with the Food and Drug Administration.
The study design followed was prepared by the late Dr. Arnold J. Lehman of the Food and Drug Administration and was considered to be appropriate testing procedure for assessing the carcinogenic properties of these color materials. - GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Seventeen hundred Swiss-Webster mice with an initial weight ranging from 17 to 25 g were used in this study.
All groups were equally divided as to sex.
Mice of the same sex were housed five per cage and were allowed free access to pellets of Purina Laboratory Chow and fresh water. - Route of administration:
- dermal
- Vehicle:
- water
- Details on exposure:
- The hair on the dorsal area of each animal was clipped with an animal clipper free of lubricating oil. Subsequent periodic clipping was performed
according to the rate of hair growth. An area of approximately 6 cm2 was treated twice weekly. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 months
- Frequency of treatment:
- Once each week for the duration of the study 0.1 ml of the solvent or of the color solution containing 1.0% of the respective color was applied to the depilated area of the mice.
- No. of animals per sex per dose:
- 600 mice for test, 700 mice for control
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- The animals were observed daily for behaviour, survival and visible or palable growth.
- Sacrifice and pathology:
- All surviving animals were terminated after approximately 18 months, when a marked increase of geriatric mortality became apparent.
All mice were necropsied after they died or were sacrificed. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Relevance of carcinogenic effects / potential:
- There was no indication of treatment related pathology since most lesions were also evident in the controls.
The test was considered appropriate for assessing the carcinogenic properties of the color additives.
All lymphomas, lymphomatous infiltrates, and leukemic infiltrates have been grouped under the term “lymphoma”.
Such changes are considered to be a single type of spontaneous neoplasia in mice which may show a range of cytological variations.
There was no significant difference in the incidence of this lesion among the groups. In the experience of the testing laboratory, 1ymphoJnatous neoplasias of some degree occur in almost all albino Swiss-Webster mice that die between 5 and 12 months of age, without regard to treatment.
There was no indication of treatment related pathology since most lesions were also evident in the controls.
No adverse reactions or pathological changes were observed following weekly dermal applications for 18 months to the dorsal area of Swiss-Webster. - Conclusions:
- No adverse reactions or pathological changes were observed following weekly dermal applications for 18 months to the dorsal area of Swiss-Webster.
- Executive summary:
No effect on growth, behavior, or survival indicative of a dose related effect was observed.
Repeated twice weekly applications of solution or suspensions of the eleven cosmetic color additives to the skin of depilated mice produced no significant incidence of gross or histopathological changes.
Macroscopic and microscopic observations revealed only such lesions as are common in geriatric mice, with equal frequency and degree in both treated and control animals.
The findings in this series of skin painting studies more clearly denote administration limited to topical administration minimizing or delimiting oral exposure. Every effort was made to place these dyes in an area with limited oral access during preening activity.
The findings described above appear to indicate freedom from significant systemic and/or dermal toxic manifestations associated with these administrations. All lymphomas, lymphomatous infiltrates, and leukemic infiltrates have been grouped under the term “lymphoma”.
Such changes are considered to be a single type of spontaneous neoplasia in mice which may show a range of cytological variations.
There was no significant difference in the incidence of this lesion among the groups. In the experience of the testing laboratory, 1ymphoJnatous neoplasias of some degree occur in almost all albino Swiss-Webster mice that die between 5 and 12 months of age, without regard to treatment.
There was no indication of treatment related pathology since most lesions were also evident in the controls.
No adverse reactions or pathological changes were observed following weekly dermal applications for 18 months to the dorsal area of Swiss-Webster.
Reference
No effect on growth, behavior, or survival indicative of a dose related effect was observed.
All lymphomas, lymphomatous infiltrates, and leukemic infiltrates have been grouped under the term “lymphoma”.
Such changes are considered to be a single type of spontaneous neoplasia in mice which may show a range of cytological variations.
There was no significant difference in the incidence of this lesion among the groups. In the experience of the testing laboratory, 1ymphoJnatous neoplasias of some degree occur in almost all albino Swiss-Webster mice that die between 5 and 12 months of age, without regard to treatment.
There was no indication of treatment related pathology since most lesions were also evident in the controls.
No adverse reactions or pathological changes were observed following weekly dermal applications for 18 months to the dorsal area of Swiss-Webster.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- mouse
Justification for classification or non-classification
There was no indication of treatment related pathology since most lesions were also evident in the controls.
Additional information
All lymphomas, lymphomatous infiltrates, and leukemic infiltrates have been grouped under the term “lymphoma”.
Such changes are considered to be a single type of spontaneous neoplasia in mice which may show a range of cytological variations.
There was no significant difference in the incidence of this lesion among the groups. In the experience of the testing laboratory, limphomatous neoplasias of some degree occur in almost all albino Swiss-Webster mice that die between 5 and 12 months of age, without regard to treatment.
Justification for selection of carcinogenicity via dermal route endpoint:
The test was considered appropriate for assessing the carcinogenic properties of the color additives.
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