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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
Study period:
From 30 APR 2007 to 10 MAY 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405; EU method B5), in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste, Linxe, France)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: between 2.63 and 3.04 kg, all within the normal range of variability
- Housing: individual boxes
- Diet: standard laboratory diet. ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 (air condition)
- Humidity (%): 42-68
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with isotonic solution
- Time after start of exposure: 1 h

SCORING SYSTEM: according to OECD TG 405, reading at 1, 24, 48 and 72 h after removal of test item

TOOL USED TO ASSESS SCORE: occular examination

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effect
Irritant / corrosive response data:
Slight reddening of the conjunctivae was noted in the three animals 1 h after treatment and persisted up to 48 h in two animals.
1 h reading: slight swelling (chemosis) in 1 animal, slight occular discharges in all treated animals
24 h and 48 h reading: slight conjunctivae redness in 2 animals.
72 h reading: no abnormal findings observed in any animal.

No coloration of the treated eyes was noted at any of the reading times.
Other effects:
- changes in body weight during the course of the study were not remarkable.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to skin when tested under the conditions of the OECD guideline 405.
Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD guideline no 405. The test item (0.1 g) was applied to the intact eye of three New Zealand White rabbits for 1 h. Redding of the conjunctivae was noted in all three animals 1 h after the tratment and persisited up to 48 h in two animals. Slight swelling was noted in one and slight occular discharge was noted in two animals in the 1 h reading.

The individual mean scores calculated across the three scoring times (24, 48, 72 h) were for corneal opacity 0.0 (three animals), for iris 0.0 (three animals), for conjunctivae redding 0.0, 0.7 and 0.7 and for chemosis 0.0 (three animals).

No abnormal findings were observed in the treated eye of any animal 72 h after treatment.

There was no indication of systemic toxicity.