4-(2,5,6,6-tetramethylcyclohex-2-enyl)but-3-en-2-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

rel-(E)-4-((1R,5R)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one

Cas Number:

599-45-1

Molecular formula:

C14H22O

IUPAC Name:

rel-(E)-4-((1R,5R)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one

Constituent 2

Reference substance name:

rel-(E)-4-((1R,5S)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one

Cas Number:

472-46-8

Molecular formula:

C14H22O

IUPAC Name:

rel-(E)-4-((1R,5S)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one

impurity 1

Reference substance name:

3-Buten-2-one, 4-(2,5,6,6-tetramethyl-1-cyclohexen-1-yl)-, (3E)-

Cas Number:

72074-84-1

Molecular formula:

C14H22O

IUPAC Name:

3-Buten-2-one, 4-(2,5,6,6-tetramethyl-1-cyclohexen-1-yl)-, (3E)-

impurity 2

Reference substance name:

3-Buten-2-one, 4-(2,2,3,6-tetramethyl-3-cyclohexen-1-yl)-, [1α(E),6α]-

Cas Number:

140632-46-8

Molecular formula:

C14H22O

IUPAC Name:

3-Buten-2-one, 4-(2,2,3,6-tetramethyl-3-cyclohexen-1-yl)-, [1α(E),6α]-

impurity 3

Reference substance name:

4-Penten-2-one, 5-(1,3,4-trimethyl-3-cyclohexen-1-yl)-, (E)-

Cas Number:

162282-94-2

Molecular formula:

C14H22O

IUPAC Name:

4-Penten-2-one, 5-(1,3,4-trimethyl-3-cyclohexen-1-yl)-, (E)-

Specific details on test material used for the study:

Identification: Irone Alpha
Description: pale yellow liquid
Batch Number 9000372727
Stability of test item: Stable under storage conditions, expiration date 17-Feb-2002

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Rationale: Recognized by the international guidelines as the recommended test system
Source: Elevage Scienfitique des Dombes, F-01400 Chatillon sur Charlaronne / France
Number of Animals: 1 male and 2 females
Age at start of treatment: 14 weeks (male), 12 and 13 weeks (females)
Body weights at start of treatment: 2.8 - 3.1 kg
Identification: By unique cage number and corresponding ear number
Acclimatization: Five to six days under laboratory conditions after health examination. Only anomals without any visual signs of illness were used for the study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml / animal

Duration of treatment / exposure:

The treated eyes were not rinsed after instillation.

Observation period (in vivo):

1, 24, 48 and 72 hours as well as 7 days after application.

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

Treatment
The eyes of the animals were examined one day prior to test item administration.
Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, Irone Alpha was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.

Observations
Viability/Mortality: Daily from delivery of the animals to the termination of test
Clinical signs: Daily from delivery of the animals to the termination of test
Body weights: At the start of acclimatization, on the day of application and at termination of observation

Irritation Scores
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commision Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours as well as 7 days after application.

Necropsy
All rabbits were sacrificed by an intravenous injection of NARCOREN into the ear at a dose of at least 1 ml/kg bosy weight and discarded.
No necropsy was performed on the animals sacrificed at termination of observation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No corneal and iridal effects were observed. Some blood vessels of the conjunctivae/nictitating membrane were definitely hyperemic in all animals at the 1-hour reading. The slight redness was still observeed in one animal at the 24 hours. Slight swelling of the conjunctivae/nictitating membrane was still observed in all animals at the 1-hour reading. A slight redness of the sclera was seen n all animals at the 1- and 24- hour reading. It persisted in one animal at the 48 and 72 hurs, A slight watery discharge was noted on one animal at the 1-hour reading. All eye reactions were clear within 7 days after treatment.

Other effects:

No staining of treated eyes was observed.
No corrosion of the cornea was observed at any of the reading times.
The body weights of all the rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the referred classification criteria (EEC Commision Directive 93/21/EEC of April 27, 1993), Irone Alpha is considered to be 'not irritating' to the rabbit eye.