2-amino-4,6-dinitrophenol

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Final Report on the Safety Assessment of Sodium Picramate

Author:

Report by Sage publishers

Year:

1992

Bibliographic source:

JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 11, Number 4, Mary Ann Liebert, Inc., Publishers

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

The percutaneous toxicity of an oxidative hair dye formulation containing 0.1 % Sodium Picramate was evaluated using 12 (6 males, 6 females) adult New Zealand white rabbits. The hair dye was mixed with an equal volume of 6.0% hydrogen peroxide and applied (1 .O mI/kg) to the dorsolateral aspects of the thoracic-lumbar area twice per week for 13 weeks. Hair was clipped from application sites throughout the study. The application sites on six animals were abraded on the first day of each week of treatment. Application sites on all animals were shampooed, rinsed, and dried 1 h
after application of the dye.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-amino-4,6-dinitrophenoxide

EC Number:

212-603-8

EC Name:

Sodium 2-amino-4,6-dinitrophenoxide

Cas Number:

831-52-7

IUPAC Name:

sodium 2-amino-4,6-dinitrophenolate

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

open

Vehicle:

other: hydrogen peroxide

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

twice per week

No. of animals per sex per dose:

6 males, 6 females

Control animals:

yes

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Gross pathological findings:

no effects observed

Effect levels

Dose descriptor:

NOAEL

Effect level:

50 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No adversed effects were observed (0.1% is equal to 50 mg/kg bw/day)

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The no observed adversed effect level (NOEL) of Sodium picramate was observed at dose level of 0.1% ( i.e. 50 mg/kgbw/day) at this dose Neither gross nor microscopic changes related to administration of the dye were observed.

Executive summary:

The percutaneous toxicity of an oxidative hair dye formulation containing 0.1 % Sodium Picramate was evaluated using 12 (6 males, 6 females) adult New Zealand white rabbits. The hair dye was mixed with an equal volume of 6.0% hydrogen peroxide and applied (1 .O mI/kg) to the dorsolateral aspects of the thoracic-lumbar area twice per week for 13 weeks. Hair was clipped from application sites throughout the study. The application sites on six animals were abraded on the first day of each week of treatment. Application sites on all animals were shampooed, rinsed, and dried 1 h after application of the dye. Three groups of untreated rats (12 per group) served as controls. Analyses of blood and urine were done during weeks 0, 3, 7, and 13. Animals were sacrificed after week 13, and both gross and microscopic examinations performed. Slight thickening of the skin was observed only at sites where the dye had been

applied. There were statistically significant differences in clinical chemistry and hematological values between experimental and control groups. However, these differences were not considered to be of toxicological significance. The results of the urinalyses were unremarkable. thus we can conclude that the no observed adversed effect level (NOEL) of Sodium picramate was observed at dose level of 0.1% ( i.e. 50 mg/kgbw/day) at this dose Neither gross nor microscopic changes related to administration of the dye were observed.