Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The acute oral toxicity of the registration substance was investigated according to OECD 401. At dose of 2000 mg/kg bw no effect was found.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1994-09-14 to 1994.09.28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: scientifically well performed and well reported study; Guideline study and GLP study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no effect
Clinical signs:
other: no effect
Gross pathology:
no effect
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of the registration substance was investigated according to OECD 401. At dose of 2000 mg/kg bw no effect was found.
Executive summary:

The acute oral toxicity of the registration substance was investigated according to OECD 401. At dose of 2000 mg/kg bw no effect was found.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity of the registration substance was investigated according to OECD 401. At dose of 2000 mg/kg bw no effect was found.


Justification for selection of acute toxicity – oral endpoint
Scientifically well performed and well documented Guideline study performed under GLP.

Justification for classification or non-classification

For the acute toxicity, no classification is warranted for the registration substance according to the OECD GHS criteria.