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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to the Draize-test (1959). In contrast to OECD guideline 405, 6 animals instead of 3 were used. For 3 animals substance was washed out after 30 seconds, whereas for the remaining animals eyes were not washed. Observation period was stopped after 72 hrs since no effects were seen.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize-Test
Principles of method if other than guideline:
The test was conducted with slight modification according to the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
GLP compliance:
no
Remarks:
(GLP was not mandatory when the study was done)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: powder, red
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.6 kg (male, average), 2.0 kg (female, average)
- Diet (e.g. ad libitum): commercial irradiated (Styles-Oxoid), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 40 mg
Duration of treatment / exposure:
for 3 animals test substance was washed out after 30 s
for 3 animals no washing out was performed
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 (4 males, 2 females)
Details on study design:
SCORING SYSTEM:
Scoring according to the Draize system ( "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no corneal opacity detected after 24, 48, 72 hrs
Irritation parameter:
iris score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no iritis detected after 24, 48, 72 hrs
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: no conjunctival redness detected after 24, 48, 72 hrs
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no chemosis detected after 24, 48, and 72 hrs
Irritant / corrosive response data:
A transient conjunctival reaction was seen in 2/3 unwashed and 1/3 washed eyes one hour after application. In one case the effect persisted for 6 hrs.
All eyes were normal at 24 hours. For regulatory purposes only time points of 24, 48, 72 hrs are considered, therefore test substance is defined as non-irritating.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information