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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:
From August 04 to 14, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
[(2S)-3-methoxy-2-methylpropyl]benzene
Molecular formula:
C11H16O
IUPAC Name:
[(2S)-3-methoxy-2-methylpropyl]benzene
Constituent 2
Chemical structure
Reference substance name:
[(2R)-3-methoxy-2-methylpropyl]benzene
Molecular formula:
C11H16O
IUPAC Name:
[(2R)-3-methoxy-2-methylpropyl]benzene
Test material form:
liquid
Details on test material:
- Physical state: Colourless liquid
Specific details on test material used for the study:
- Storage condition of test material: Stored at room temperature, away from the light and heat (tox specific)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BERTHO, 22120 Yffiniac, France
- Weight at study initiation: 2.8 kg (average weight)
- Housing: Animals were housed individually on floor grid.
- Diet: Complete pelleted rabbit maintenance diet (Energie H326, COFNA, 37000 - Tours, France)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS: Environmental conditions and controls were in accordance with the requirements of the 86/609/EEC guideline.

IN-LIFE DATES: From: August 04, 1997 To: August 14, 1997.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
No washing was done.
Observation period (in vivo):
1, 24, 48 and 72 h after instillation and then on Days 5-11
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not done

SCORING SYSTEM: Draize scale, as described in the OECD guideline No. 405.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 11 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 11 days
Irritation parameter:
chemosis score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- At 1 h after instillation: A moderate irritation of the conjunctivae (crimson coloration, tumefaction, important discharge) was observed in all animals and a slight congestion of the iris was noted in one animal.
- At 24 h after instillation: The discharges had nearly disappeared and a conjunctival enanthema was noted in all animals with a very slight oedema in two of them. Marked redness (index 2) was observed and a diffuse area of cornea opacity was reversible within 24 h in one animal.
- At 72 h after instillation: No ocular reaction was observed in one animal. A slight palpebral irritation (enanthema of index 2 and oedema of index 1) was noted in the two other animals.
- The chemosis was reversible within 7 days and the palpebral redness disappeared 11 days after instillation.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Eye irritation response data for each animal at each observation time

Score at time point

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

1 h (Day 1)

0 / 0 / 0

0 / 0 / 0

1 / 0 / 0

2 / 2 / 2

1 / 1 / 1

3 / 3 / 2

24 h (Day 1)

1 / 0 / 0

1 / 0 / 0

0 / 0 / 0

2 / 1 / 1

1 / 0 / 1

1 / 0 / 0

48 h (Day 2)

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

2 / 1 / 1

1 / 0 / 1

1 / 0 / 0

72 h (Day 3)

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

2 / 0 / 2

1 / 0 / 1

1 / 0 / 1

Day 5

0 / - / 0

0 / - / 0

0 / - / 0

2 / - / 2

1 / - / 1

1 / - / 1

Day 6

0 / - / 0

0 / - / 0

0 / - / 0

2 / - / 2

1 / - / 1

0 / - / 0

Day 7

0 / - / 0

0 / - / 0

0 / - / 0

2 / - / 2

0 / - / 0

0 / - / 0

Day 8

0 / - / 0

0 / - / 0

0 / - / 0

1 / - / 1

0 / - / 0

0 / - / 0

Day 9

0 / - / 0

0 / - / 0

0 / - / 0

1 / - / 1

0 / - / 0

0 / - / 0

Day 10

0 / - / 0

0 / - / 0

0 / - / 0

1 / - / 1

0 / - / 0

0 / - / 0

Day 11

0 / - / 0

0 / - / 0

0 / - / 0

0 / - / 0

0 / - / 0

0 / - / 0

Average 24, 48 and 72 h

0.3 / 0.0 / 0.0

0.3 / 0.0 / 0.0

0.0 / 0.0 / 0.0

2.0 / 0.7 / 1.3

1.0 / 0.0 / 1.0

1.0 / 0.0 / 0.3

Reversibility

Completely

reversible

Completely

reversible

-

Completely

reversible

Completely reversible

Completely reversible

Average time (unit) for reversion

48 h

48 h

-

72 h to 11 days

24 h to 7 days

24 h to 6 days

Key:

- : No reading

Applicant's summary and conclusion

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

In an eye irritation study performed according to the OECD Guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the right eye of 3 female New Zealand White rabbits. The lids are then gently held together for about one second in order to prevent loss of the material. The left eye remained untreated and served as control. Animals were observed at 1, 24, 48 and 72 h after test material instillation, and then on Days 5-11. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.

A moderate irritation of the conjunctivae was observed in all animals and a slight congestion of the iris was noted in one animal at 1 h after instillation. 24 h after instillation, the discharges had nearly disappeared and a conjunctival enanthema was noted in all animals with a very slight oedema in two of them. Marked redness was observed and a diffuse area of cornea opacity was reversible within 24 h in one animal. No ocular reaction was observed in one animal at 72 h. A slight palpebral irritation was noted in the two other animals. The chemosis was reversible within 7 days and the palpebral redness disappeared 11 days after instillation.

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.3 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 2.0 / 0.7 / 1.3 for conjunctivae score and 1.0 / 0.0 / 1.0 for chemosis score.

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

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