Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
other: JMAFF, Japanese Test Guidelines
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
2000mg/kg (10ml/kg) body weight (only dosed to females).
200mg/kg (10ml/kg) body weight (dosed to males and females).
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
other: mortality
Effect level:
2 000 mg/kg bw
Remarks on result:
other: 2 of the 3 females died.
Sex:
male/female
Dose descriptor:
other: mortality
Effect level:
> 200 mg/kg bw
Remarks on result:
other: None of the 6 animals dosed at 200mg/kg died.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - <= 2 000 mg/kg bw
Mortality:
See effect levels above.
Clinical signs:
The surviving female dosed at 2000mg/kg body weight showed clinical signs throughout the study period. The animals dosed at 200mg/kg had recovered from the symptoms between days 2 and 4, except for staining of the fur, which was observed throughout the study period.
Body weight:
The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities. Watery fluid in the uterus, found in one female, is related to a stage in the oestrous cycle and is a normal finding.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria