Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Test performed accoding to OECD Guideline of 12/05/1981

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD of 12/05/1981
Principles of method if other than guideline:
Substance administrated to a group of 10 animals (5 males/5 females) : dose = 5000mg/kg in aqueous solution (20ml/kg).
Mortality, general behaviour and weight evolution of animals have been controlled during a 14 days period after single administration.
Anatomopathologic examination was performed on each animal at the end of the study.
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Cream to white powder
Specific details on test material used for the study:
OP 1/87 SI

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Doses:
Single dose = 5000mg/kg in aqueous solution (20ml/kg).
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat. (total fraction)
Mortality:
No mortality
Clinical signs:
No significant clinical signs
Body weight:
No evolution

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD 50 oral/rat > 5000mg/kg