1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol

Endpoint summary

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1962

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Unknown purity, old and not very well described method, Not GLP

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

GLP compliance:

no

Species:

rat

Sex:

male/female

Route of administration:

oral: feed

Duration of treatment / exposure:

90 days

Frequency of treatment:

in diet

Remarks:

Doses / Concentrations:
1%
Basis:
nominal in diet

Remarks:

Doses / Concentrations:
5%
Basis:
nominal in diet

No. of animals per sex per dose:

10 at 1%, 5 at 5%

Control animals:

yes, plain diet

Dose descriptor:

LOAEL

Effect level:

ca. 10 000 mg/kg diet

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: toxic effect in kidney and spleen

Critical effects observed:

not specified

Conclusions:

LOAEL < 10,000 mg/kg diet

Executive summary:

Ten male and ten female rats per group were exposed to C.I. Pigment Red 4 in the diet for 90 days at two concentrations of 5% and 1%. 

No rats died during the study. The general behavior of rats at 5% and 1% was not affected. The body weight gain was lower in the 5% group compared to controls for male rats. Body weight gain of female rats at 5% concentration of test substance in the diet were not affected.

The histological examination of the organs did show some signs of changes related to the experiment in the kidney and spleen when exposed to 1% of C.I. Pigment Red 4 and more prominently at 5%.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LOAEL

500 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

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.

Species:

mouse

Sex:

male/female

Vehicle:

water

Duration of treatment / exposure:

18 month

Frequency of treatment:

2 times a week

Remarks:

Doses / Concentrations:
0.1 mL 1% suspension of test item
Basis:

No. of animals per sex per dose:

50

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

Critical effects observed:

not specified

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.

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

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.

Species:

mouse

Sex:

male/female

Vehicle:

water

Duration of treatment / exposure:

18 month

Frequency of treatment:

2 times a week

Remarks:

Doses / Concentrations:
0.1 mL 1% suspension of test item
Basis:

No. of animals per sex per dose:

50

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

Critical effects observed:

not specified

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Most sensitive species with the lowest LOAEL

Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: spleen; urogenital: kidneys