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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Mar 1995
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:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as control
Duration of treatment / exposure:
test substance remained in the eye, eye was not rinsed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
The treatment did not result in any effect on body weight.

Any other information on results incl. tables

Results of the study

      Irritant Effects (Score)         
 Animal    24 h 48 h   72 h  Mean scores
 1  Cornea 0 0  0  0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 0 0 0 0.0
   Conjunctiva (swelling) 0 0 0 0.0
 2  Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
    Conjunctiva (reddening) 0 0 0 0.0
    Conjunctiva (swelling) 0 0 0 0.0
 3   Cornea 0 0 0 0.0
    Iris 0 0 0 0.0
    Conjunctiva (reddening) 0 0 0 0.0
    Conjunctiva (swelling) 0 0 0 0.0
 4   Cornea 0 0 0 0.0
    Iris 0 0 0 0.0
    Conjunctiva (reddening) 0 0 0 0.0
    Conjunctiva (swelling) 0 0 0 0.0

A slight secretion and slight transient reddening and swelling of the conjunctivae and slight injection of blood vessels were seen in 2 animals on administration day. These animals were without findings from day 2 onwards. The other 2 females showed no signs of irritation at all.

Applicant's summary and conclusion

Executive summary:

The single administration of AD-Cyanhydrin-3 -Ethyleneketal into the right eye of 4 female rabbits with a volume of 0.1 ml/eye (corresponding to 58.6 -67.9 mg) resulted in slight secretion and slight transient reddening and swelling of the conjunctivae and slight injection of blood vessels in 2 animals on administration day. These animals were without findings from day 2 onwards. The other 2 females showed no signs of irritation at all.

According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea, iris, conjuntival swelling and conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.