Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study was performed predating current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
Not specified
Doses:
3.2, 4.0, 5.0 and 6.3 g/kg bw
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 700 mg/kg bw
Based on:
test mat.
95% CL:
>= 4 200 - <= 5 260
Mortality:
1/6, 5/6 and 6/6 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively
Distribution of mortality:
- 3200 mg/kg bw: no mortality
- 4000 mg/kg bw dose group: 1 animal died on day 5
- 5000 mg/kg bw dose group: 3 animals died on day 2 and 2 animals died on day 4.
- 6300 mg/kg bw dose group: 6 animals died on day 1
Clinical signs:
Ataxia (uncoordinated movements) and dermal irritation was seen.
Gross pathology:
Hemorrhagic enteritis (inflammation of the gut) was seen.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute harmful
Remarks:
in accordance with CLP (1272/2008 and its updates)
Conclusions:
The acute dermal toxicity test showed an LD50 of 4700 mg/kg bw in rabbits.
Executive summary:

A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance. In this study 6 rabbits (sex unspecified) were administered 3.2, 4.0, 5.0 and 6.3 g/kg bw test substance on the skin. 1/6, 5/6 and 6/6 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Clinical signs was ataxia and hemorrhagic enteritis during gross pathology. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was 4700 mg/ kg bw. Based on these results, the test substance is not considered to be acute harmful.