Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Compliance

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG, B.1
GLP compliance:
yes
Test type:
other: standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat,TiF: RAlf (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
other: distilled water containing 0/5% carboxymethylcellulose and 0.1% Polysorbate 80

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male : 2000mg/kg bw ; number of animals: 5; Number of deaths: 0.
Male : 5000mg/kg bw ; number of animals: 5; Number of deaths: 0.
Female : 2000mg/kg bw ; number of animals: 5; Number of deaths: 0.
Female : 5000mg/kg bw ; number of animals: 5; Number of deaths: 0.
Clinical signs:
Unspcific symptoms of intoxication, reversible with 10 days in all animals
Gross pathology:
Effects on Organs: no findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not conisdered harmful.
Executive summary:

Due to the lack of information provided by ECHA, it is difficult to assess this end point fully. It appears from information provided that the substance has low toxicity.