Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Aug to Sep 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 34517
- Batch No.: 27002001-07

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: physiol. saline + Myrj 53
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No mortality occurred. One male animal showed ruffled fur and atactic gait on the first day after administration of ZK 34517. The other animals were without findings over the whole study period. No compound-related findings were observed in body weight gain. At autopsy a diminished size of seminal vesicles were seen in the male animals.

Applicant's summary and conclusion

Executive summary:

The single oral administration of the test substance (ZK 34517) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. One male animal showed ruffled fur and atactic gait on the first day after administration of ZK 34517. The other animals were without findings over the whole study period. No compound-related findings were observed in body weight gain. At autopsy a diminished size of seminal vesicles were seen in the male animals.

The acute oral toxicity of Dimethylenketon in rats is therefore above 2000 mg/kg body weight.