Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: OECD TG 401: > 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:
August 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
somewhat limited documentation but standard procedures are applied
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
Substance is a liquid
Doses:
Limit dose of 5000 mg/kg bw
No. of animals per sex per dose:
Total 10 (no sex specified).
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: Yes, because know from other Moreno studies
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Urinary incontinence and slight lethargy were observed at 18 hours.
Body weight:
No data.
Interpretation of results:
other: Not acute harmful.
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
An LD50 of >5000 mg/kg bw was obtained in the acute oral toxicity study with rats. Based on the results, the substance is not acute harmful.
Executive summary:

In an acute oral toxicity study one group of 10 rats were orally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No deaths occurred. Urinary incontinence and slight lethargy were observed at 18 hours. Based on the results, the substance is not acute harmful and a LD50 of >5000 mg/kg bw was obtained in the acute oral toxicity study with rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

In an acute oral toxicity study one group of 10 rats were orally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No deaths occurred. Urinary incontinence and slight lethargy were observed at 18 hours. Based on the results, the substance is not acute harmful and a LD50 of >5000 mg/kg bw was obtained in the acute oral toxicity study with rats.

Justification for classification or non-classification

Based on the results, the substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2008 and its amendments.