Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1999

Materials and methods

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

Test material

Constituent 1
Reference substance name:
refer to confidential details on test material
IUPAC Name:
refer to confidential details on test material

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
other: bi-distilled water
No. of animals per sex per dose:
5 males and 5 females

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: 0Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No signs of toxicity for females. For males orange feces were observed at day 2 and 3.

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The analogue substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 2000 mg/kg.
Executive summary:

The analogue substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 2000 mg/kg.