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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
6 instead of 3 animals used
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
17 beta-cyano-17 alpha-hydroxy-4-androsten-3-on
IUPAC Name:
17 beta-cyano-17 alpha-hydroxy-4-androsten-3-on
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.