Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

No indication of carcinogenic properties was observed in a skin painting study in mice with 50 mg/kg bw of Pigment Red 57:1 (Carson 1984).

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
Reference
Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1961 -1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Performed prior to introduction of GLP. Limited details reported. Designed mainly to detect skin cancer. Full histopathology only performed for 5 of 50 animals per dose group.
Qualifier:
according to guideline
Guideline:
other: protocol agreed between the U.S. Food and Drug Agency and CTFA
Principles of method if other than guideline:
Dermal application onto shaved mouse skin twice weekly for 18 months.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): D&C Red 7
- Substance type: pigment
- Physical state: solid
- Analytical purity: 98%
- Lot/batch No.: W4602
Species:
mouse
Strain:
ICR
Remarks:
Swiss Webster derived
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: not applicable
- Housing: single
- Diet: ad libitum
- Water:ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS: no data
Route of administration:
dermal
Vehicle:
water
Details on exposure:
- Application volume: 0.1 mL of a 1% suspension in water;
- Application site: doral, applied with an automatic syringe and distributed on the skin with a rubber applicator over a surface of 6 cm2
- Time intervals for shavings or clipplings: Initially, the hair on the dorsal area of each animal was clipped with an animal clipper free of lubricatirig oil. Subsequent periodic clipping was performed according to the rate of hair growth. The test item suspension was prepared fresh weekly.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
471 days (ca 18 months)
Frequency of treatment:
twice per week
Post exposure period:
none
Dose / conc.:
1 other: mg/mouse
Remarks:
corresponding to 0.166 mg/cm2 (nominal); 50 mg/kg bw/day (nominal)
No. of animals per sex per dose:
- Test substance: 50
- Control: 150
- Positive control: 50
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: Based on human exposure from use in lipstick
Positive control:
3,4-benzpyrene, dissolved in acetone
Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily

DERMAL IRRITATION: No data

BODY WEIGHT: No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: No data

CLINICAL CHEMISTRY: No data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes

HISTOPATHOLOGY: Yes
- Preparation of: brain, pituitary, thyroid, thymus, liver, spleen, kidney, adrenal, stomach, small and large intestines, urinary bladder, axillary lymph nodes, testes, ovary, skin from area of treatment, any tissue massess, grossly abnormal organs; complete pathology only for each five males and females; skin and grossly abnormal organs for all animals)
Statistics:
no data
Clinical signs:
not specified
Mortality:
mortality observed, non-treatment-related
Description (incidence):
No effects in comparison to the control
Body weight and weight changes:
not examined
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
- Extramedullary ematopoiesis was found in the spleen, although this was consistent with the vehicle control group and therefore considered not treatment-related.
- Lesions that were observed in several organs could alsno not be attributed to exposure to the test material.
Histopathological findings: neoplastic:
no effects observed
Description (incidence and severity):
No apparent change in number of neoplasias, such as in the mammary glands or internal organs, that was attributable to the test material when compared to the control.
Other effects:
effects observed, treatment-related
Description (incidence and severity):
Ectoparasitism was greater than that in the control group, that may have contributed to epidermal changes.
Dose descriptor:
NOAEL
Effect level:
>= 0.17 other: mg/cm2; corresponds to 1 mg per mouse or roughly 50 mg/kg bw
Sex:
male/female
Basis for effect level:
other: no adverse effects observed

In the mid-1960s a number of cosmetic color additives originally identified by US Food and Drug Administration and the Cosmetic, Toiletry and Fragrance Association (CTFA) (formerly the Toilet Goods Association) were evaluated as part of an overall program to determine safety for human usage in a series of coal tar derived colors which were then in wide use by the cosmetic, drug and food industries.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Because, no carcinogenicity has been observed and the substance is also not genotoxic, the substance is not considered to be classified for carcinogenicity according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.

Additional information

Skin painting

No indication of carcinogenic properties was observed in a skin painting study in mice with Pigment Red 57:1(CA) (Carson 1984). The investigation was performed prior to introduction of GLP. Limited details are given in the literature publication. The study was designed by the US competent authority and an industry association to assess the safety of the use in lipstick. For 18 months, mice were given 0.1 ml of an aqueous solution of 1% onto an area of 6 cm2 twice per week. This corresponds to a dose of 1 mg per mouse (50 mg/kg bw) per treatment. Full histopathology was only performed for 5 of 50 animals per dose group.