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:
other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V, 92/69/EEC, B1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl CDBR
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Males: 5000 mg/kg bw.; number of animals 5; number of deaths 0
Females: 5000 mg/kg bw.; number of animals 5; number of deaths 0
Clinical signs:
The only sign of toxicity was soft stools in two females on the day of treatment.
Body weight:
All animals showed expected gains in bodyweight over the treatment period.
Gross pathology:
There were no effects observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were no deaths and no significant signs of reaction to treatment at the limit test dosage of 5000 mg/kg bw. The test substance is therefore considered to be practically non-toxic and is not classified according to CLP criteria.