[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: old study without GLP, but fulfill basically scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkali blue flushings

IUPAC Name:

Alkali blue flushings

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

Alkali blue flushings FL-14-637 was received as a blue paste assumed to be 100% active.

Test animals

Species:

rabbit

Strain:

other: New zealand variety

Sex:

not specified

Details on test animals or test system and environmental conditions:

Ten mature albino rabbits of the New Zealand variety were selected from the stock colony for this study.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test article was applied at 2g/kg to the clipped skin of five intact and five abraded rabbits. The rabbits were wrapped with a dam. After 24 hours, the wrapping was removed and the residue gently washed off.

Duration of exposure:

24hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

The test site was examined for erythema and edema and scores were recorded daily for 14 days. Bodyweights were recorded on days 0, 3, 7, 10 and 14. A gross examination of the viscera was conducted on all rabbits sacrificed at 14 days.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no adverse effect was observed at level of 2000 mg/kg.

Mortality:

One animal died on day 10.

Clinical signs:

No erythema or edema were noted during the 14-day observation period. The general appearance of the rabbits remained good throughout.

Body weight:

Bodyweight gain was acceptable for all rabbits during the 14-day study.

Gross pathology:

No gross pathology was noted in the rabbits sacrificed at 14 days.

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, test article would be considered dermally non-toxic.

Executive summary:

This study was conducted to evaluate the dermal toxicity of tes article in the rabbit accoring to the Federal Hazardous Substances Act. The paste was applied at 2000 mg/kg of body weight to the intact and abraded skin. One animal died on day 10 which is believed not compound related. No dermal reactions were observed. Body weight gain and general appearance of the rabbits remained good throughout the 14 -day observation period.

Therefore, test substance can be considered dermally non-toxic.