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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Feb to Mar 1995
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:
1995
Report date:
1995

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 0.3 - 0.35 ml) to male and female rats; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 30-60 min after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
3,3-Ethylenedioxy- 17 alpha-hydroxy-5-androstene-17 beta-carbonitrile
IUPAC Name:
3,3-Ethylenedioxy- 17 alpha-hydroxy-5-androstene-17 beta-carbonitrile
Details on test material:
- Name of test material (as cited in study report): ZK 74857
- Batch No.: 26013012

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
for local effects 72 hours, whole study 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 mortalities occurred and nocompound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.

Any other information on results incl. tables

Results of the local tolerance:

    Test compound ZK 74857 (2000 mg/kg)                 Animal number and sex
 Location (finding)  Time-point after end of exposure  54M 55M  56M  84F 85F 86F 
 Reddening and scab formation  30 -60 min  0 0  0 0 0 0 
   24 hours  0 0  0 0 0 0 
   48 hours  0 0  0 0 0 0 
   72 hours  0 0  0 0 0 0 
Individual mean values:  0 0  0 0 0 0 
 Mean value of all animals:                    0
               
 Swellings  30 -60 min  0 0  0 0  0  0 
   24 hours  0 0  0  0  0  0 
   48 hours  0 0  0  0  0  0
   72 hours  0 0  0  0  0  0 
Individual mean values      0 0  0  0  0  0 
Mean values of all animals                    0 

The irritation index for males and females is 0.

Applicant's summary and conclusion

Executive summary:

The single dermal administration of AD-Cyanhydrin-3 -Ethylenketal 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, with an irritation index according to Draize of 0.