Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jul 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:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 instead of 5 animals/sex used according to acute-toxic-class-method (OECD 423)
GLP compliance:
yes
Test type:
standard acute 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

Vehicle:
physiological saline
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
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 compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.

No local intolerance reactions at the application sites were observed.

Applicant's summary and conclusion

Executive summary:

The single dermal administration of the test substance (ZK 34517) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of Dimethylenketon in rats is therefore above 2000 mg/kg body weight.

No local intolerance reactions at the application sites were observed.