Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given: comparable to standard guideline. comparable to guideline study with acceptable restrictions Pre-guideline and pre-GLP study. Only basic data given, but considered sufficiently reliable for the purpose of hazard assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(no details on test animals, environmental condition of animal room, dermal exposure (duration, occlusive-dressing or not, abraded skin or not), body weight)
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Physical state:no data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
Duration of exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for toxicity and clinical signs daily for 14 days.
- Necropsy of survivors performed: Yes
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: One animal died on Day 4.
Mortality:
1 animal died on day 4
Clinical signs:
Moderate redness was observed in 10/10 animals. Slight oedema in 3/10 and Moderate oedema in 7/10.
Body weight:
No data
Gross pathology:
Liver dark, intestine slightly red and fecal matter dried around anal region in the animal which died.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 and to the GHS as the dermal LD50 is greater than 5000 mg/kg bw in rabbits.
Executive summary:

In an acute dermal toxicity study (limit test), the skin of ten rabbits was exposed to test material at dose of 5000 mg/kg bw. Animals were observed for mortality and clinical signs at least daily for 14 days. 1/10 animal died on Day 4 post exposure. Dermal irritation was observed in all the animals.

Rabbit Dermal LD50 > 5000 mg/kg bw

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.