Registration Dossier

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:
2006-02-20 to 2006-02-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study following OECD guideline without any deviation.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Details on test material:
Batch No.: 049807
Purity: 67.2% (sum of the three main constituents)
Name of test material (as cited in study report): TERPINEOL MULTICONSTITUENT
Physical state: colourless liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 30 November 2017

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gerome, Linxe, France
- Weight at study initiation: between 2.15 and 2.57 kg
- Housing: individual box installed in conventional air conditioned
-Diet(ad libitum): supplied by UAR, Villemoison s/Orange, France, ad libitum
-Water(ad libitum): tap water from public distribution system, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20 and 22
- Humidity (%): between 30 and 37
-Air changes: at least 10 cycles per hour
-Photoperiod (hours dark / hours light): 12/12

IN-LIFE DATES: From: 2006-02-20 To: 2006-02-26

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:
24 hours, no washing done
Observation period (in vivo):
Observations performed at 1, 24, 48 and 72 h up to 21 days
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: According to the scale of lesion scores published in Directive n° 2004/73/EC and OECD guideline n°405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Remarks:
chemosis(A)
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
conjunctivae score
Remarks:
redness (C)
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Remarks:
lesion (D)
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
opacity (E)
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Remarks:
chemosis (A)
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
redness (C)
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Remarks:
lesion (D)
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
opacity (E)
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Remarks:
chemosis (A)
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
redness (C)
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Remarks:
lesion(D)
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
opacity (E)
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Moderate redness at the conjunctival level associated with moderate chemosis and moderate opacity at the corneal level. All effects were totally reversible within the 7th day at the latest.
Other effects:
No data

Any other information on results incl. tables

Table 1: individual and mean scores of Conjunctivae, Iris and Cornea

Animal 

Time after treatment

CONJUNCTIVAE

IRIS

CORNEA

CHEMOSIS (A)

REDNESS (C)

LESION (D)

OPACITY (E)

A 7230

24 hours

1

2

0

2

48 hours

1

2

0

2

72 hours

1

2

0

2

TOTAL

MEAN

3

6

0

6

1.0

2.0

0.0

2.0

A 7231

24 hours

1

2

0

2

48 hours

1

2

0

2

72 hours

1

1

0

2

TOTAL

3

5

0

6

MEAN

1.0

1.7

0 .0

2.0

A 7232

24 hours

2

2

0

2

48 hours

2

1

0

0

72 hours

1

1

0

0

TOTAL

5

4

0

2

MEAN

1.7

1. 3

0.0

0.7

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test item is irritant to eyes and should be classified in Category 2 according to CLP regulation (EC) No 1272/2008.
Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy adults female rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item in one eye while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded (scale of lesion scores according to Directive n° 2004/73/EC and OECD guideline 405).

The occular reactions observed during the study have been moderate. The individual mean scores for conjunctival chemosis were 1.0, 1.0 and 1.7, conjunctival redness scores were 2.0, 1.7 and 1.3, cornea opacity scores were 2.0, 2.0 and 0.7 and iris lesion scores were 0.0 for all animals.

At the conjuctivae level, a moderate redness, noted 24 h after the test item installation and totally reversible between the 6th and 7th day of the test, was associated with a moderate chemosis, noted 1h after the test item instillation and totally reversible between the 5th and 6th day of the test. At corneal level, moderate opacity was observed 24 h after the test substance administration and totally reversible between the 3rd and 6th day.

Therefore, the test item is considered as irritating to eyes according to CLP regulation (EC) No 1272/2008.