Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 95.2%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
The shaved back of animals was wiped by gauze soaked in acetone – ethanol (1:1), then by gauze soaked in saline. Relevant amount of the test sample was applied on the depilated area of skin, covered by mull, plastic foil and held in contact by technical tape. Then fixative bandage was put on. The bandage was overlapped by technical tape and fixed around the whole body so that the test sample is in contact with the skin and cannot be ingested. After 24 hours the bandage was removed.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females were tested.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Toxicity of the test sample was established according to evaluation of mortality, clinical signs of intoxication, body weight increment, and pathological findings within 14-day test. No clinical signs of intoxication were observed after application of the test sample. No pathological-anatomical findings were recorded within necropsy.

The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.
Executive summary:

Direct black 112 was tested for the acute dermal toxicity. 5 males and 5 females of Wistar rats were tested at 5000 mg/kg bw. After 24 hr exposure, the toxicity was established according to evaluation of mortality, clinical signs of intoxication, body weight increment, and pathological findings within 14-day test. No clinical signs of intoxication were observed after application of the test sample. No pathological-anatomical findings were recorded within necropsy.

The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.