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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 guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Tridecanol A

- Physical state / appearance: Liquid / colorless - clear

- Degree of purity / content: 99.95 area-%

- Homogeneity: The test substance was homogeneous by visual inspection.

- Batch No.: from continuous production

- Test substance No.: 01/0324-1

- Stability: The stability was determined by reanalysis.

- Storage conditions: Room temperature, exclusion of oxygen (under nitrogen)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Strain / quality: New Zealand white A1077 INRA (SPF);

- Origin: Centre Lago S.A., 01 540 Vonnas, France;

- Age at the beginning of the study: about 4 months;

- Body weight range at the beginning of the study: 3.14 - 3.19 kg;

- No. of animals per cage: Single housing;

- Type of diet: Kliba-Labordiet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day);

- Watering: Tap water ad libitum;

- Acclimatization period: At least 5 days before the beginning of the study.

- Housing conditions:
Temperature: 20 - 24°C;
Relative humidity: 30 - 70%;
Illumination period: 12 h light (6.00 am - 6.00 pm), 12 h darkness (6.00 pm - 6.00 am);

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 (undiluted)



Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days (animal No. 1), 7 days (animal Nos. 2, 3)
Number of animals or in vitro replicates:
3 (2 females, 1 male)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 hours


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 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: opacity was only observed in animal No. 2
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 hours
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: iritis was only observed in animal No. 2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 hours
Score:
1.4
Max. score:
3
Reversibility:
fully reversible within: 7 days (animals Nos. 2 and 3), 14 days (animal No. 1)
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 24 hours (animal Nos. 1 and 3), 72 hours (animal No. 2)
Irritant / corrosive response data:
Moderate conjunctival redness (grade 2), slight conjunctival chemosis (grade 1) and moderate discharge (grade 2) were observed in all animals 1 hour after application. Moderate conjunctival redness persisted in all animals until 24 hours and in 1 animal up to 48 hours. In 2 animals moderate conjunctival redness decreased to slight (grade 1) at 48 hours. After 72 hours all animals showed slight conjunctival redness, which persisted in 1 animal until day 7. Slight conjunctival chemosis (grade 1) persisted in 1 animal up to 48 hours after application, slight discharge (grade 1) was seen in this animal up to 24 hours. Moderate iritis (grade 1) was observed in 1 animal 24 hours after application. The same animal showed slight corneal opacity (grade 1) from 48 hours up to 72 hours after application and small retraction in the eyelid from 24 hours up to 7 days. The ocular reactions were reversible in 2 animals within 7 days and in 1 animal after 14 days. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.7 and 0.0 for corneal opacity, 0.0, 0.3 and 0.0 for iris lesions, 1.3, 1.7 and 1.3 for redness of the conjunctiva and 0.0, 0.7 and 0.0 for chemosis.

Any other information on results incl. tables

Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means.

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

1

1

1

2

2

2

1

2

3

24 hours

0

0

0

0

0

0

0

1

0

2

2

2

0

1

0

0

1

0

1

2

3

48 hours

0

1

0

0

1

0

0

0

0

1

2

1

0

1

0

0

0

0

1

2

3

72 hours

0

1

0

0

1

0

0

0

0

1

1

1

0

0

0

0

0

0

1

2

3

7 days

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

1

14 days

0

0

0

0

0

0

1

2

3

ME

0.0

0.7

0.0

0.0

0.3

0.0

1.3            0.0

1.7            0.7

1.3            0.0

ME

0.2

0.1

1.4            0.2

Animal 2 showed small retraction in the eyelid from 24 hours up to 7 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information