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Administrative data

Description of key information

Acute oral toxicity: similar or equivalent to OECD TG 401: LD50 > 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
Species:
rat
Strain:
not specified
Sex:
not specified
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

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.

In addition, also an acute dermal toxicity study (similar to OECD TG 402) is available with an LD50 in rabbits of > 5000 mg/kg bw, not indicating an impact on the classification and therefore not included in detail.

Justification for classification or non-classification

The substance does not have to be classified for acute oral toxicity according to the criteria outlined in EU CLP (1272/2008/EC and its amendments).