Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines. Read-across hypothesis: for details please see read-across report in IUCLID section 13

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971
Reference Type:
publication
Title:
Unnamed
Year:
1961
Report date:
1961

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Final Order, Enforcement Regulations (Fed. Register of August 12, 1961, Vol 26, No. 155, pages 7333-7341)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2500 to 3500 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10.7% of body surface
- Type of wrap if used: made of rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing: after removal of sleeves by thorough wiping
- Time after start of exposure: up to 24 h
Duration of exposure:
up to 24 h
Doses:
5000 mg/kg
No. of animals per sex per dose:
6 (3 animals with intact skin, 3 animals with abraded skin)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no animals died within the 14 days observation period
Sex:
not specified
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths occurred
Clinical signs:
dry and cracked skin noted
Body weight:
no data
Gross pathology:
no data

Any other information on results incl. tables

Read-across justification: for details please see read-across report in IUCLID section 13

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP Regulation
Conclusions:
Under the tested conditions, the substance did not reveal acute dermal toxicity.
Executive summary:

The test item (purity: not stated) was subjected to test acute dermal toxicity in albino rabbits. This study was conducted according to the requirements of Federal Register, 1961 (Vol 26, No. 155, pages 7333 -7341). The undiluted substance was applied at a limit dose of 5000 mg/kg bw onto the intact or abraded skin of the animals (3 animals per condition) for up to 24 h under occlusive conditions.

During the 14 days observation period dry and cracked skin could be noted, but no animal died. The given results lead to a LD50 > 5000 mg test item per kg bw (LD0 = 5000 mg/kg bw; Shelanski and Moldovan, 1971).

This study was judged to be reliable with restrictions (RL2), due to missing information on substance purity and the missing necropsy data.

Categories Display