Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
3.2, 4.0, 5.0 and 6.3 g/kg bw
No. of animals per sex per dose:
10 animals (sex unspecified) per dose group
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:
>= 4 020 - <= 5 500
Mortality:
3/10, 6/10 and 9/10 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 dose group: no mortality occurred
- 4000 mg/kg bw dose group: 1 animal died on day 1 and 2 animals died on day 3.
- 5000 mg/kg bw dose group: 1 animal died on day 1 and day 2, 3 animals died on day 5.
- 6300 mg/kg bw dose group: 6 animals died on day 1, 2 animals died on day 2 and 1 animal died on day 5.
Clinical signs:
Immediate stimulation followed by ataxia (uncoordinated movements)
Gross pathology:
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 oral toxicity test showed an LD50 of 4700 mg/kg bw
Executive summary:

A pre-guideline study, equivalent to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 rats (sex unspecified) were administered with 3.2, 4.0, 5.0 and 6.3 g/kg bw. 3/10, 6/10 and 9/10 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Directly after dosing stimulation and ataxia (uncoordinated movements) were seen. Enteritis (inflammation of the gut) was seen at gross pathology. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be 4700 mg/kg bw. Based on these results, the test substance is not considered to be acute harmful.