Registration Dossier

Administrative data

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.

Data source

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

Materials and methods

Test guideline
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

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

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

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:
No deaths occurred.
Clinical signs:
Urinary incontinence and slight lethargy were observed at 18 hours.
Body weight:
No data.

Applicant's summary and conclusion

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.