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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 June 21 to 24, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one
EC Number:
260-486-7
EC Name:
1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one
Cas Number:
56973-85-4
Molecular formula:
C13H20O
IUPAC Name:
1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
Constituent 2
Chemical structure
Reference substance name:
1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
Cas Number:
56973-84-3
Molecular formula:
C13H20O
IUPAC Name:
1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
Test material form:
liquid
Remarks:
Colorless to pale yellow liquid
Details on test material:
- Storage condition of test material: In a refrigerator (2-8°C)
- Stability under test conditions: Stable at storage conditions

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: 13 weeks
- Weight at study initiation: Animal n°1: 2613g ; Animal n°2: 2726g ; Animal n°3: 2581g
- Housing: Animals were housed individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 64/99) from Provimi Kliba AG, 4303 Kaiseraugst, Switzerland
- Water: Community tap water from Itingen, ad libitum, in water bowls.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: June 15, 1999 To: June 24, 1999.

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
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not done

SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
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, #2 and #3
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, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.00. In all animals, slight reddening of the conjuctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was noted, one hour after treatment. In one animal, slight watery discharge persisted until 24 hours. All signs of irritation were reversible after 48 hours.
Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occured.
- No staining by the test article was observed.
- The body weight of all rabbits were considered to be within the normal range of variability.

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 Conjunctivae
Opacity (/4) (/2) Redness (/3) Chemosis (/4)
1 h (Day 1) 0 / 0 / 0 0 / 0 / 0 1 / 1 / 1 1 / 0 / 0
24 h (Day 1) 0 / 0 / 0 0 / 0 / 0 0 / 0 / 0 0 / 0 / 0
48 h (Day 2) 0 / 0 / 0 0 / 0 / 0 0 / 0 / 0 0 / 0 / 0
72 h (Day 3) 0 / 0 / 0 0 / 0 / 0 0 / 0 / 0 0 / 0 / 0
Average 24, 48 and 72 h 0 / 0 / 0 0 / 0 / 0 0 / 0 / 0 0 / 0 / 0

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 EU Method B.5 and OECD Guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the left eye of 3 New Zealand White rabbits (1 male and 2 females). The lids are then gently held together for about one second to prevent loss of the article. The right eye remained untreated and served as the reference control. Animals were observed at 1, 24, 48 and 72 h after test material instillation. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity) were scored according to the Draize scale.

In all animals, slight reddening of the conjuctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was noted, one hour after treatment. In one animal, slight watery discharge persisted until 24 hours. All signs of irritation were reversible after 48 hours.

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, iris score, conjunctivae score and 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.