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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
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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.