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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 to 30 June 2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
study conducted according to OECD 404 Guideline - supposed to be GLP but not specified - with acceptable deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Deviations: information on animals, environmental conditions and method not reported
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Deviations: information on animals, environmental conditions and method not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Remarks:
supposed to be GLP but not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene
EC Number:
220-585-8
EC Name:
(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene
Cas Number:
2825-82-3
Molecular formula:
C10H16
IUPAC Name:
(1R,2S,6R,7S)-tricyclo[5.2.1.0^{2,6}]decane
Test material form:
liquid
Details on test material:
- Physical appearance: colourless liquid
- Storage conditions: at room temperature
Specific details on test material used for the study:
Date of receipt: 08 June 2005

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)
- Age at study initiation: not specified
- Weight during study: 2.49-2.95 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: not specified
- Water: not specified
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature: 18–23 °C
- Humidity: 59-68 %
- Air changes: not speicified
- Photoperiod: not specified

IN-LIFE DATES: 20 to 30 June 2005

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:
single instillation
Observation period (in vivo):
Ocular examinations were performed on both eyes 1, 24, 48 and 72 h & Days 4 to 9 after instillation, according to a numerical evaluation.
Number of animals or in vitro replicates:
3 males
Details on study design:
TREATMENT
- 0.1 mL of the test item was instilled, as supplied, 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: Not specified

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
Max. score:
4
Reversibility:
other: not applicable
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:
2
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
positive 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: 6 days
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:
2
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
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:
0
Max. score:
4
Reversibility:
other: not applicable
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:
1.3
Max. score:
3
Reversibility:
fully reversible within: 5 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 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight to moderate conjunctival reactions were noted, fully reversible:
moderate redness recorded 1 hour after instillation and fully reversible between day 6 and day 10 associated with a slight chemosis recorded 1 hour after instillation and fully reversible between day 3 and day 7.
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 No. Cornea Iris Conjunctivae
redness chemosis
A6747 (#1) A6748 (#2) A6750 (#3) A6747 (#1) A6748 (#2) A6750 (#3) A6747 (#1) A6748 (#2) A6750 (#3) A6747 (#1) A6748 (#2) A6750 (#3)
1h 0 0 0 0 0 0 2 2 2 1 1 1
24h 0 0 0 0 0 0 2 2 2 1 1 1
48h 0 0 0 0 0 0 2 2 1 1 1 0
72h 0 0 0 0 0 0 2 2 1 1 1 0
4 days 0 0 0 0 0 0 2 1 1 1 1 0
5 days 0 0 0 0 0 0 1 1 0 1 0 0
6 days 0 0 0 0 0 0 1 1  - 0 0  -
7 days 0 0 0 0 0 0 1 1  - 0 0  -
8 days 0 0 0 0 0 0 1 1  - 0 0  -
9 days 0 0 0 0 0 0 0 0  - 0 0  -
mean 24/48/72h 0 0 0 0 0 0 2.0 2.0 1.3 1.0 1.0 0.3

-: not examined

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Under the test conditions, the test substance is classified as eye irritation Category 2 (H319: Causes severe eye irritation) according to Regulation (EC) N°1272-2008 (CLP) and as Category 2A "irritating to eyes" according to the GHS.
Executive summary:

In an eye irritation study conducted according to OECD 405/EU Method B.5 guidelines and in compliance with GLP, 3 New Zealand White male rabbits were exposed to 0.1 mL of test substance in one eye while the contralateral eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Days 4 to 9 following treatment and graded according to the Draize method.  

 

Fully reversible slight to moderate conjunctival reactions were noted during the observation period.

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

Under the test conditions, test substance is classified as eye irritation Category 2 (H319: Causes severe eye irritation) according to Regulation (EC) N°1272-2008 (CLP) and as Category 2A "irritating to eyes" according to the GHS.

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