Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-GLP study, similar to OECD TG 401, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
test was done before GLP came into force
Test type:
standard acute method
Limit test:
yes

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
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Details on study design:
- Observation period: 14 days
- Frequency of observations: daily

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 of 10 rats was observed dead at day 2.
Clinical signs:
Slight lethargy

Applicant's summary and conclusion

Interpretation of results:
other: Not Classified
Remarks:
Criteria not met according to EU CLP 1272/2008 and its amendments
Conclusions:
The acute oral toxicity test showed an LD50 of > 5000 mg/kg bw. Therefore the substance does not need to be classified according to GHS.
Executive summary:

Acute oral toxicity: In this study, 10 rats were administered the substance at a dose level of 5000 mg/kg bw. Slight lethargy was observed and one of ten rats was observed dead at day two. The acute oral LD50 for the substance was determined to be > 5000 mg/kg bw. Therefore the substance does not need to be classified for acute oral toxicity according to EU CLP 1272/2008 and its amendments.