Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jan 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: only shortly reported GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
6 instead of 3 animals used
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 74.804
- Batch No.: Ba 76700

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
other: left side served as a control
Duration of treatment / exposure:
4 hours
Observation period:
5 days
Number of animals:
3 males and 3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
Body weight over 4 days was unchanged.

Applicant's summary and conclusion

Executive summary:

500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 3 male and 3 female rabbits for an exposure period of 4 h. Evaluation of skin irritation was made according to Draize.

In this skin irritation study AD-Cyanhydrin was not irritating to the skin.