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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): C13 - C15 - Alkohol
- Physical state: colorless liquid
- Analytical purity: 99.3% alcohols (0.5% low boiling substances, 0.2% high boiling substances)
- Composition of test material, percentage of components: 29.5% i-C13-alcohol, 33% n-C13-alcohol, 19% i-C15-alcohol, 17.8% n-C15-alcohol
- Lot/batch No.: from continuous production
- Sustance number: 88/577

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach / Main, Germany
- Weight at study initiation: male: 3.2 kg; mean(females): 3.2 kg
- Housing: single
- Diet: Kliba 341, 4 mm, Klingentalmuehle, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study (same housing conditions as during the study)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- 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:
See observation period, no washing out conducted
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
SCORING SYSTEM: according to OECD 405 / Draize


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: see table below for details
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Other effects:
Pupil contraction in one animal 24 and 48 h after application.

Any other information on results incl. tables

Animal Number

Evaluation Interval

Corneal Opacity

Area of Corneal Opacity

Iris

Conjunctivae

Red

SW

DI

1

2

3

1 hour

0

0

0

0

0

0

0

0

0

2

2

2

0

0

0

2

3

2

1

2

3

24 hours

0

0

0

0

0

0

0

0

0

1

1

0

0

0

0

0

0

0

1

2

3

48 hours

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

2

3

72 hours

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

2

3

ME

0.0

0.0

0.0

0.0

0.0

0.0

0.3            0.0

0.3            0.0

0.0            0.0

ME

0.0

0.0

0.2            0.0

Calculation of the mean according to 83/467/EEC criteria of July 29 th, 1983.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met