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: Study was performed following GLP standards and standard acute method following EEC. B1 guidelines. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
EEC.B1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
polyethylene glycol
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: No signs of toxicity observed
Gross pathology:
Effects on organs:No treatment related abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a study carried out in accordance with GLP and EEC guideline B.1, test substance (EC No. 413-920-6) was evaluated for its acute oral toxicity potential by standard acute method at dose level of 2000 mg/kg bw in male and female wistar rats. LD50 value for acute oral toxicity was found to be greater than 2000 mg/kg bw. So test substance was not classified for acute oral toxicity according to Regulation (EU) 1272/2008.