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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:
From 22 MAY 1979 to 25 MAY 1979.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), conducted with slight modification.
Deviations:
yes
Remarks:
(no further information)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Californian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd
- Age at study initiation: 12-16 weeks
- Weight at study initiation: male av. 2.38 kg and female av. 2.13 kg
- Housing: individually
- Diet: Labsure, Christopher Hill Group, ad libitum
- Water: sterile filtered water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 14 h / 10 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
No washing of eyes in 3 animals (group 1). Washing after 30 sec in 3 other animals (group 2).
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with approx. 200 ml of warm water (3 rabbits, group 2). No washing in group 1 (other 3 rabbits)
- Time after start of exposure: 30 seconds (3 rabbits, group 2)

SCORING SYSTEM: basically in accordance with OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 (group 1)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #2 (group 1)
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 h after application
Irritation parameter:
cornea opacity score
Basis:
animal: #3 (group 1)
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Remarks:
72 h after appl.
Irritation parameter:
iris score
Basis:
animal: #1 - #3 (group 1)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3 (group 1)
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 h after appl.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal: #2 (group 1)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal: #1 - #3 (group 1)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #4, #5 (group 2)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #6 (group 2)
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Remarks:
72 h after appl.
Irritation parameter:
iris score
Basis:
animal: #4 - #6 (group 2)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: #4 (group 2)
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 h after appl.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal: #5, #6 (group 2)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal: #4 - #6 (group 2)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Unwashed eyes (group 1):
Slight corneal opacity was seen in 3/3 eyes one hour after compound application, in 2/3 eyes at 24 h and in 1/3 eyes at 48 h after application. No iridial effects were observed. Very slight conjunctival reactions were seen in 3/3 eyes one hour after application and in 2/3 eyes 24 h after application, fully reversible by 48 h after application. All eyes were normal by 72 h.
Washed eyes (group 2):
Slight corneal opacity was seen in 2/3 eyes one hour after application and in 1/3 eyes 24 h and 48 h after application. Nor iridial effects were observed. Very slight conjunctival reactions were seen in 2/3 eyes one hour after application and in 1/3 eyes at 24 h, fully reversible by 48 h after application. All eyes were normal 72 h after application.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. This conclusion is legitimate as three animals (group 1) were tested basically in accordance with today's standard methods regarding dosing, exposure duration, scoring system, reading time points and the observed eye responses were fully reversible 72 hours after application. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The test material was tested for eye irritancy according to a procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), conducted with slight modification. 0.1 ml test substance was applied to the conjunctival sac of one eye each of 6 animals (no washing in 3 animals, group 1, or after 30 seconds in 3 animals, group 2) and eye responses were watched for three days. No iridial effects or chemosis were observed. Very slight corneal effects were seen up to 48 h after application and slight conjunctival redness up to 24 h after application. All eyes were normal by 72 h. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.