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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP / OECD Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Centre International de Toxicologie

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): D-(+)-Isobutyllactat
- Physical state: liquid
- Analytical purity: 99.5%
- Isomers composition: D/(D+L) = 99.4%
- Lot/batch No.: PR 596
- Storage condition of test material: 4°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cunicole du Val de Seile, 80160 Prouzel, Frankreich
- Weight at study initiation: mean: 2.6 ± 0.2 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
no washed out
Observation period (in vivo):
1, 24, 48, 72 hours and daily until day 7
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: as described in 84/449/EG Annex V B5 and J.O.R.F. (Journal officiel de la Republique Francaise) from 24th of october 1984

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: within 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2.1
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 6 days

Any other information on results incl. tables

Eye Irritation Scores:

Readings

Animal

cornea

Iris

conjunctiva

opacity

area

redness

swelling

1 h

1

0

0

1

1

3

2

0

0

1

1

3

3

0

0

1

1

2

24 h

1

1

4

1

2

1

2

1

4

1

2

1

3

1

4

1

3

2

48 h

1

1

4

1

2

0

2

1

4

1

2

0

3

1

4

1

2

1

72 h

1

1

4

1

2

0

2

1

4

1

2

0

3

1

4

1

2

1

6 d

1

1

2

0

0

0

2

1

2

0

0

0

3

1

1

0

0

0

7 d

1

0

0

0

0

0

2

0

0

0

0

0

3

0

0

0

0

0

mean 24 - 72 h

1

1.0

 

1.0

2.0

0.3

2

1.0

 

1.0

2.0

0.3

3

1.0

 

1.0

2.3

1.3

mean

 

1.0

 

1.0

2.1

0.7

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU