Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jul 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well reported GLP study with acceptable restrictions

Data source

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

Materials and methods

Principles of method if other than guideline:
combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.4-0.9 ml) to male and female rats; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 1 h after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
GLP compliance:
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

Test system

Preparation of test site:
not specified
Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3/sex

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Other effects:
No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.

Applicant's summary and conclusion

Executive summary:

The single dermal administration of Dimethylenketon to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The test substance was tolerated without any local skin irritations.