Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
However was subject to Quality Assurance
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% aqueous guar gum
Doses:
5000mg/kg
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:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None observed
Body weight:
All animals gained weight normally
Gross pathology:
No treatment related changes observed

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria (Reg 1272/2008) are not met
Conclusions:
The oral oral LD50 >5000 mg/kg to rats.