3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-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

Justification for type of information:

data is from experimental reports following standard procedures

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To determine the ocular irritation potential of the test chemical im rabbits.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one

EC Number:

204-846-3

EC Name:

3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one

Cas Number:

127-51-5

Molecular formula:

C14H22O

IUPAC Name:

3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one

Test material form:

liquid

Details on test material:

- Name of test material : 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
- Common name : alpha-isomethyl ionone
- Molecular formula : C14H22O
- Molecular weight : 206.327 g/mol
- Smiles notation : C1([C@@H](\C=C(\C(C)=O)C)C(=CCC1)C)(C)C
- InChl : 1S/C14H22O/c1-10-7-6-8-14(4,5)13(10)9-11(2)12(3)15/h7,9,13H,6,8H2,1-5H3/b11-9+
- Substance type : Organic
- Physical state : Liquid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye acted as control

Amount / concentration applied:

0.1 ml of the test sample was instilled into the right eye of the rabbits

Duration of treatment / exposure:

7 days

Observation period (in vivo):

The rabbits were examined every 24 hours for four days and then again on the 7th day.

Duration of post- treatment incubation (in vitro):

No data available

Number of animals or in vitro replicates:

3 healthy, normal albino rabbits were used for the study.

Details on study design:

Scoring System: The scorings were made according to the Draize scale for scoring of ocular lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

80

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

10

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

7 d

Score:

14

Max. score:

20

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

The score is the mean of conjunctivae redness, chemosis and conjunctivae discharge.

Irritant / corrosive response data:

The score is the mean of conjunctivae redness, chemosis and conjunctivae discharge.

Other effects:

No data available

Any other information on results incl. tables

Results of the Individual animals after instillation of the test chemical

Rabbit 1

Area of the eye involved	Results
	1 day	2 days	3 days	4 days	7 days
Cornea
A. Opacity	0	0	0	0	0
B. Area of cornea involved	0	0	0	0	0
Total = A*B*5 (maximum = 80)	0*0*5 = 0
Iris
A. Values	0	0	0	0	0
Total = A*5 (maximum = 10)	0*5=0
Conjunctivae
A. Redness	3	2	2	2	0
B. Chemosis	2	2	1	1	0
C. Discharge	2	1	1	0	0
Score = (A+B+C)*2 (maximum = 20)	(3+2+2)*2 = 14

Rabbit 2

Area of the eye involved	Results
	1 day	2 days	3 days		4 days	7 days
Cornea
A. Opacity	0	0	0		0	0
B. Area of cornea involved	0	0	0		0	0
Total = A*B*5 (maximum = 80)	0*0*5 = 0
Iris
A. Values	0	0		0	0		0
Total = A*5 (maximum = 10)	0*5=0
Conjunctivae
A. Redness	3	2		2	2		0
B. Chemosis	2	2		1	1		0
C. Discharge	2	1		0	0		0
Score = (A+B+C)*2 (maximum = 20)	(3+2+2)*2 = 14

 

Rabbit 3

Area of the eye involved	Results
	1 day	2 days	3 days		4 days	7 days
Cornea
A. Opacity	0	0	0		0	0
B. Area of cornea involved	0	0	0		0	0
Total = A*B*5 (maximum = 80)	0*0*5 = 0
Iris
A. Values	0	0		0	0		0
Total = A*5 (maximum = 10)	0*5=0
Conjunctivae
A. Redness	3	2		2	2		0
B. Chemosis	2	2		1	1		0
C. Discharge	2	1		1	0		0
Score = (A+B+C)*2 (maximum = 20)	(3+2+2)*2 = 14

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Instillation of the test chemical did not produce any corneal opacity or iris congestion, while an intense conjunctival irritation occurred involving chemosis and discharge.On the seventh day of discharge the treated eyes were normal. Based on these observations,the test chemical can be considered to be not irritating to rabbit eyes.

Executive summary:

In an eye irritation study, the toxic effects of the test chemical was investigated to see if it produced any irritation when instilled into eyes of rabbits. 0.1 ml of the test sample was instilled into the right eye of 3 healthy, normal albino rabbits. The rabbits were examined every 24 hours for four days and then again on the 7th day. The left eye acted as control. The scorings were made according to the Draize scale for scoring of ocular lesions. As seen by the results, instillation of the test chemical did not produce any corneal opacity or iris congestion. However, an intense conjunctival irritation did occur, involving chemosis and discharge. On the seventh day of discharge, the treated eyes were normal. Therefore, the test chemical can be considered to be not irritating to rabbit eyes.