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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Study period:
Dec 2000
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:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
17β-hydroxy-17-(3-hydroxypropyl)androst-4-ene-4-one
EC Number:
259-701-7
EC Name:
17β-hydroxy-17-(3-hydroxypropyl)androst-4-ene-4-one
Cas Number:
55542-27-3
Molecular formula:
C22H34O3
IUPAC Name:
17 beta-Hydroxy-17 alpha-(3-hydroxypropyl)-4-androsten-3-one
Details on test material:
- Name of test material (as cited in study report): ZK 57797
- Batch No.: 59012052, white powder
- Purity: approx. 91.2% (DC)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males

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
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
No animal died during the course of the study, clinical signs were not observed. 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
 Cornea  1 0 0  0  0.0
   2 0 0 0 0.0
   3 0 0 0 0.0
 Iris  1 0 0 0 0.0
 2 0 0 0 0.0
   3 0 0 0 0.0
 Conjunctivae Redness 1 0 0 0 0.0
   2 0 0 0 0.0
   3 0 0 0 0.0
  Conjunctivae Chemosis  1 0 0 0 0.0
   2 0 0 0 0.0
   3 0 0 0 0.0

One hour after instillation a slight reddening of the conjunctivae (grade 1) was observed in all animals. Moreover, in one animal a slight swelling of the conjuctivae was observed. All animals were without findings from day 2 onwards.

Applicant's summary and conclusion

Executive summary:

The single administration of 0.1 g Hydroxypropyltesto into one eye of male rabbits resulted in slight reddening of the conjunctivae in all animals and in slight swelling of the conjunctivae in one animal on administration day. All animals were without findings from day 2 onwards.

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.