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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
Study period:
20-30 April 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted according to OECD Guideline 405 with deviations: age at study initiation, feeding conditions not reported. These deviations do not affect the quality of the study and are not considered to be relevant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
age at study initiation, feeding conditions not reported
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
13 December 2005

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Source and lot/batch No.of test material: MANE FILS SA / 713060- Physical state: Colourless liquid- Date received: 13 March 2006- Expiration date of the lot/batch: February 2007- Purity test date: February 2006- Test item was considered at 100% for the study.- Name of test material (as cited in study report): Figolide A45240- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Elevage de Gérome, Quartier Labaste – F40260 Linxe- Weight at study initiation: 2.34-2.61 kg- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.- Diet: No data- Water: No data- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature: 19-23 °C- Humidity: 38-61 %IN-LIFE DATES: 20-30 April 2006

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye serving as control
Amount / concentration applied:
TEST MATERIAL - Amount(s) applied (volume or weight with unit): 0.1 mL - Concentration (if solution): Undiluted
Duration of treatment / exposure:
No washing was done
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1, 24, 48 and 72 h & Days 4, 5 and 6 following treatment, according to a numerical evaluation.
Number of animals or in vitro replicates:
3 males
Details on study design:
TREATMENTA volume of 0.1 mL of the pure test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.REMOVAL OF TEST SUBSTANCE - Washing: No SCORING SYSTEM: According to OECD guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 5 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The ocular reactions observed during the study have been moderate, and totally reversible in the three animals:- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between the 4th and the 6th day of the test, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 4th day of the test;- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation in two animals and totally reversible between the 3rd and the 7th day of the test.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Individual and mean scores of conjunctivae, iris and cornea

 

Time / Animal

 

Cornea

 

Iris

 

Conjunctivae

 

redness

 

chemosis

 

1

2

3

1

2

3

1

2

3

1

2

3

1 h

0

0

0

0

0

0

2

2

2

2

2

2

24 h

2

0

2

0

0

0

2

2

2

2

1

1

48 h

0

0

2

0

0

0

1

1

2

1

0

0

72 h

0

0

1

0

0

0

1

0

1

0

0

0

D4

0

-

1

0

-

0

1

-

0

0

-

0

D5

0

-

1

0

-

0

0

-

0

0

-

0

D6

-

-

0

-

-

0

-

-

0

-

-

0

Total 24/48/72 h

2

0

5

0

0

0

4

3

5

3

1

1

Mean 24/48/72 h

0.7

0.0

1.7

0.0

0.0

0.0

1.3

1.0

1.7

1.0

0.3

0.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance is not classified as irritating to eyes according to the criteria of annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an eye irritation study conducted according to OECD 405 Guideline and in compliance with GLP, test substance was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 mL, the other eye remained untreated serving as control. The lids were then gently held together for about one second in order to prevent loss of the test substance. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and 4, 5 and 6 days after treatment and graded according to the Draize method.  

 

The ocular reactions observed during the study have been moderate, and totally reversible in the three animals:

- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between the 4th and the 6th day of the test, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 4th day of the test;

- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation in two animals and totally reversible between the 3rd and the 7th day of the test.

 

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.7, 0.0, 1.7 for cornea score; 0.0, 0.0, 0.0 for iris score; 1.3, 1.0, 1.7 for conjunctivae score and 1.0, 0.3, 0.3 for chemosis score.

 

Under the test conditions, test substance is not classified as irritating to eyes according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.