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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to 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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-Androstene -3,17- dione
- Lot/batch No.: JC9410

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: females
- Source: Schriever
- Age at study initiation: not reported
- Weight at study initiation: 3.4-4.4 kg
- Housing: singly in conventional housing conditions (metal cage)
- Diet and water: ad libitum
- Acclimation period: > 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 48-56
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye remained untreated and served as control
Amount / concentration applied:
0.1 mL, corresponding to 54.0-64.3 mg substance
Duration of treatment / exposure:
0.1 mL substance was applied into the conjunctival sac of the right eye; no rinsing of the eyes reported.
Observation period (in vivo):
Examinations were terminated after 4 days, since no changes at all were observed during this period.
Number of animals or in vitro replicates:
4 (females)
Details on study design:
One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed. Conjunctivae, eyelids, cornea and iris were evaluated before application, 0.5, 1 and 2 hours thereafter and then once daily until termination of the study on day 4.

SCORING SYSTEM:
According to "Illustrated Guide for Grading Eye Irritation by Hazardous Substances", US Department of Health, Education and Welfare, Food and Drug Administration, Washington DC 20204, USA.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
/reddening
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The single application of the substance into the conjunctival sac of the rabbit eye led to slight to moderate transient irritation (vessel injection and secreation in 2/4 animals) solely on the day of application. From day 2 onwards all animals were without findings.
Other effects:
not reported

Applicant's summary and conclusion

Conclusions:
No classification required for eye irritation/corrosion according to Directive 67/548/EEC and Regulation (EC) 1272/2008.
Executive summary:

0.1 mL test substance was applied into the conjunctival sac of 4 rabbits. Assessment of eye irritation was made on the application day and after 24, 48, and 72 hours according to "Illustrated Guide for Grading Eye Irritation by Hazardous Substances", US Department of Health, Education and Welfare, Food and Drug Administration, Washington DC 20204, USA. Solely on application day the substance provoked slight to moderate transient irritation (vessel injection and secreation) in 2/4 animals. From Day 2 onwards all animals were without findings.