Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Test type:
other: BASF method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
- Concentration in vehicle: 2% to 30%
Doses:
5000 mg/kg
No. of animals per sex per dose:
No data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 300 mg/kg bw
Based on:
act. ingr.
Remarks on result:
not determinable due to absence of adverse toxic effects
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality
Clinical signs:
None
Body weight:
NA
Gross pathology:
No effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study in rats, the LD50 (gavage) value of the test item was reported to be greater than 5000 mg/kg bw (test mat.).
Executive summary:

In an acute oral toxicity study according to BASF method, rats were given a single oral dose of the test item at a dose of 5000 mg/kg bw and were observed for 7 days. The LD50 was reported to be greater than 5000 mg/kg body weight.