Registration Dossier

Administrative data

Description of key information

Skin Irritation:

The erythema and edema scores for animals 1, 2, 3 were 0.67,1,1 and 0.67,1,1 respectively.

Based on the scores,the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)  is considered to be not irritating to rabbit skin.

Eye Irritation:

The scores for conjunctivae redness was 1,0,1, chemosis were 0.33,0.33,0.67, cornea opacity score were 0,0,0 and iris score for all animals were 0,0,0.

Based on the scores, (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)  can be considered to be not irritating to rabbit eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Remarks:
deactivated phrase
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Experimental study made available by ECHA
Qualifier:
according to
Guideline:
other: Annex V
Principles of method if other than guideline:
To assess the dermal irritation potential of in rabbits
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (IUPAC name): (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)
- Common name: Lokanol
- Molecular formula: C15H26O
- Molecular weight: 222.3694 g/mol
- InChl: 1S/C15H26O/c1-13(2)10(6-12-8-15(12,13)4)5-11-7-14(11,3)9-16/h10-12,16H,5-9H2,1-4H3
- Substance type: Organic
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
not specified
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 h
Number of animals:
3
Details on study design:
not specified
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 14 days
Other effects:
Other effects:
Very slight and diffuse erythema and oedema were noted in two animals after 24 hours and in all 3 animals from 48 hours to seven days after application. No erythema or oedema were observed at 14 days.
Interpretation of results:
other: not irritating
Conclusions:
The erythema and edema scores for animals 1, 2, 3 were 0.67,1,1 and 0.67,1,1 respectively.
Based on the scores,the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) is considered to be not irritating to rabbit skin.
Executive summary:

The dermal irritation potential of the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was assessed in rabbits. The study was performed according to the Guidelines mentioned in Annex V. 3 rabbits were used for the study.

(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was applied to the skin of rabbits under semi-occlusive conditions (dose and duration not mentioned). The test sites were evaluated for erythema and edema at 24, 48, 72 hours. The erythema and edema scores for animals 1, 2, 3 were 0.67,1,1 and 0.67,1,1 respectively. Any observed effect were fully reversible within 14 days.Very slight and diffuse erythema and oedema were noted in two animals after 24 hours and in all 3 animals from 48 hours to seven days after application. No erythema or oedema were observed at 14 days. Based on the scores, the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) is considered to be not irritating to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Experimental study made available by ECHA
Qualifier:
according to
Guideline:
other: Annex V
Principles of method if other than guideline:
To assess the ocular irritation potential of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) in rabbits
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (IUPAC name): (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)
- Common name: Lokanol
- Molecular formula: C15H26O
- Molecular weight: 222.3694 g/mol
- InChl: 1S/C15H26O/c1-13(2)10(6-12-8-15(12,13)4)5-11-7-14(11,3)9-16/h10-12,16H,5-9H2,1-4H3
- Substance type: Organic
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data available
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
24, 48 and 72 h
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
no data available
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
At 1 hour, all animals exhibited moderate reddening and slight swelling of the conjunctivae and moderate watery discharge and hyperemia of the sclera blood vessels. At 24 hours, two animals had slightly reddened conjunctivae, which resolved by 48 hours; the other animal had a moderately reddened conjunctivae and moderate swelling with partial eversion of the eye lid, which resolved by 72 and 48 hours,
respectively. hour. All findings were reversible after 72 hours.
Interpretation of results:
other: not irritating
Conclusions:
The scores for conjunctivae redness was 1,0,1, chemosis were 0.33,0.33,0.67, cornea opacity score were 0,0,0 and iris score for all animals were 0,0,0.
Based on the scores, (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) can be considered to be not irritating to rabbit eyes.
Executive summary:

The ocular irritation potential of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was assessed in rabbits. The study was performed according to the Guidelines mentioned in Annex V. 3 rabbits were used for the study. Undiluted (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was instilled in to the eyes of rabbits (dose not mentioned). The treated eyes were observed for effects at 24, 48 and 72 hours after exposure. Reversibility of any observed effect: Changes fully reversible within 3 days.

At 1 hour, all animals exhibited moderate reddening and slight swelling of the conjunctivae and moderate watery discharge and hyperemia of the sclera blood vessels. At 24 hours, two animals had slightly reddened conjunctivae, which resolved by 48 hours; the other animal had a moderately reddened conjunctivae and moderate swelling with partial eversion of the eye lid, which resolved by 72 and 48 hours,respectively. hour. All findings were reversible after 72 hours.

The scores for conjunctivae redness was 1,0,1, chemosis were 0.33,0.33,0.67, cornea opacity score were 0,0,0 and iris score for all animals were 0,0,0. Based on the scores, (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) can be considered to be not irritating to rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

The dermal irritation potential of the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was assessed in rabbits. The study was performed according to the Guidelines mentioned in Annex V. 3 rabbits were used for the study.

(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was applied to the skin of rabbits under semi-occlusive conditions (dose and duration not mentioned). The test sites were evaluated for erythema and edema at 24, 48, 72 hours. The erythema and edema scores for animals 1, 2, 3 were 0.67,1,1 and 0.67,1,1 respectively. Any observed effect were fully reversible within 14 days.Very slight and diffuse erythema and oedema were noted in two animals after 24 hours and in all 3 animals from 48 hours to seven days after application. No erythema or oedema were observed at 14 days. Based on the scores, the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) is considered to be not irritating to rabbit skin.

Eye Irritation:

The ocular irritation potential of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was assessed in rabbits. The study was performed according to the Guidelines mentioned in Annex V. 3 rabbits were used for the study. Undiluted (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was instilled in to the eyes of rabbits (dose not mentioned). The treated eyes were observed for effects at 24, 48 and 72 hours after exposure. Reversibility of any observed effect: Changes fully reversible within 3 days.

At 1 hour, all animals exhibited moderate reddening and slight swelling of the conjunctivae and moderate watery discharge and hyperemia of the sclera blood vessels. At 24 hours, two animals had slightly reddened conjunctivae, which resolved by 48 hours; the other animal had a moderately reddened conjunctivae and moderate swelling with partial eversion of the eye lid, which resolved by 72 and 48 hours,respectively. hour. All findings were reversible after 72 hours.

The scores for conjunctivae redness was 1,0,1, chemosis were 0.33,0.33,0.67, cornea opacity score were 0,0,0 and iris score for all animals were 0,0,0. Based on the scores, (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) can be considered to be not irritating to rabbit eyes.

Justification for classification or non-classification

Available studies for test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) indicates that it is not likely to cause irritation to skin and eyes.

Hence, (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) can be considered as “Non Irritant” to skin and eyes and cannot be classified for skin and Eye Irritation according to CLP criteria.