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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Nov 1998
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:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
17 beta-Acetoxy-5 alpha-androstan-3-one
EC Number:
601-431-2
Cas Number:
1164-92-7
Molecular formula:
C21 H32 O3
IUPAC Name:
17 beta-Acetoxy-5 alpha-androstan-3-one
Details on test material:
- Name of test material (as cited in study report): adrostanolone acetate (5180)
- Lot/batch No.: 11630702

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye remained untreated and served as control
Duration of treatment / exposure:
once until end of study, test substance remained in eye
Observation period (in vivo):
observation before administration, 0.5, 1 and 2 hours thereafter and then every 23 to 24 hours until day 4 of test
Number of animals or in vitro replicates:
2/sex

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
>= 0.25
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: reddening
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
ca. 0.17
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: swelling
Other effects:
slight to moderate reddening and slight to severe swelling of the conjunctivae observed in all animals on administration day. On day 2 only slight conjunctival reddening and swelling were seen in three out of four animals. All animals were without any findings on day 3.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Androstanolone acetate is not irritating to the eye. Classification is not required
Executive summary:

After single administration of ZK 5180 into the conjuctival sac of the rabbit eye (2 male; 2 female rabbits) slight to moderate reddening and slight to severe swelling of the conjuctivae were observed in all animals on the application day, which was fully reversible by day 3 after administration.