Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nitrohydrochinondimethylether

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
source of the animals: Hoechst AG breeding colony
weight: 2,4 - 3,5 kg
age: about 3 - 5 months
temperature: 20+-3°C
humidity: 50+-20%
light: 12 hours/day
diet: Altromin 2123 ad libitum, water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of each test animals served as control
Amount / concentration applied:
100 mg test substance into the left eye
Duration of treatment / exposure:
Duration of treatment was 24 hours. 24 h after instillation eyes were rinsed with physiol. saline .
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight effects were fully reversible within 24 h
Irritation parameter:
conjunctivae score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: initial slight effects were fully reversible within 24 h
Irritation parameter:
iris score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
cornea opacity score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritant / corrosive response data:
Time point: 30 - 60 min after instillation
Effect: Yellow discharge

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test the test substance is not eye-irritating.
Executive summary:

Nitrohydrochinondimethylether was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance were applied into the conjunctival sac of one eye from each of three rabbits. The other eye remained untreted and served as control. After 24 h exposure time the eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, 72 h, after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.

Based on the findings in this test the test substance is not eye-irritating.