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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 08 NOV 1988 to 15 NOV 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405; EU method B5), in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

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: Hoechst AG, breeding colony, Germany
- Age at study initiation: abour 3-5 months
- Weight at study initiation: 2.1 - 3.6 kg
- Housing: single
- Diet: mixed feed (Altromin 2123), ad libitum, and about 15 g hay daily
- Water: deionized, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 50 +/-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiologic saline solution
- Time after start of exposure: 24 h

SCORING SYSTEM:
Scores were read 1, 24, 48 and 72 h after test substance application as well as after 7 days.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 24 and 72 h reading

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2 and #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals #2 and #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritant / corrosive response data:
- no corneal effects were observed.
- iris scores for animal #1,2,3 after 1h: (0,1,0), after 24 h: (1,0,0). After 48 h, 72 h and 7 days scores for all animals were 0.
- conjunctivae redness scores for animal #1,2,3 after 1 h: (2,2,1), 24 h: (2,1,1), 48 h: (2,2,1), 72 h: (1,0,0) and 7 days: (0,0,0)
- chemosis scores for animals #1,2,3 after 1 h: (2,2,2), 24 h: (2,0,0). After 48 h, 72 h and 7 days scores for all animals were 0.
All effects were completely reversible within 7 days.
Other effects:
No other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is slightly irritating to the eyes when tested under the conditions of the OECD guideline 405. Chemosis was seen at 1 (all animals) and 24 h (one animal), being reversible within 48 h. Redness of the conjunctivae was also seen in all animals in the 1 h reading, being fully reversibly after 7 days. Animal #2 had an iris score of 1 in the 1 h reading, animal #1 in the 24 h reading. These effects were fully reversible within 48 h. No corneal effects were observed.

The effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008.
Executive summary:

The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405.

Chemosis was observed in all three animals 1 h after application. The effect was fully reversible within 48 h. Conjunctival redness was observed in all three animals up to 72 h after application , reversible by seven days. Iridial effects were noted in one animal up to 24 h. Corneal opacity was not oberved in any animal.