Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non-GLP study that meets key elements of current OECD 402 guideline with some notable restrictions (8 day observation instead of 14, skin surface area <10%). Suitable for use in classification if dermal absorption rate and oral toxicity taken into account.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
8-day observation period instead of 14; skin surface area <10%, top dose was only 200 mg/kg
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
other: Acute dermal toxicity

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Buten-2-diol-1,4 (cis)

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm²

REMOVAL OF TEST SUBSTANCE
- Washing : After the exposure time the skin was washed with detergent and water

Duration of exposure:
24 hours
Doses:
200 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No abnormal clinical signs were observed.
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

 Dose  Sex  1 h  24 h  48 h  8 days
 200 mg/kg  male  0/5  0/5  0/5  0/5
 200 mg/kg  female  0/5  0/5  0/5  0/5

Applicant's summary and conclusion