Registration Dossier

Administrative data

Description of key information

Skin Sensitization:

The dermal sensitization potential of test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was assessed in Guinea Pigs. There were no positive responses in test or control animals following re-challenge performed one week later, with 10 or 5% test substance. Hence the test chemical was considered as not sensitization to the skin of treated guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 (Maximisation)
Principles of method if other than guideline:
To assess the dermal sensitiization potential of test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) in guinea pigs
GLP compliance:
not specified
Type of study:
other: Maximization test
Justification for non-LLNA method:
no data available
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:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
intradermal: 5% in Polyethylene glycol
Topical: 100%
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
25% in polyethylene glycol
Day(s)/duration:
48 hours
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
10% and 5% in polyethylene glycol
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: not specified
- Test groups: 10
- Control group:5
- Site: not specified
- Frequency of applications: not specified
- Duration: not specified
- Concentrations: Intradermal: 5% in Polyethylene glycol; Topical: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: not specified
- Exposure period: 24hours
- Test groups: 10
- Control group: 5
- Site: not specified
- Concentrations: 25%in polyethylene glycol
- Evaluation (hr after challenge): at 24 and 48 hours

C. RE-CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 7 days
- Exposure period: 24hours
- Test groups: 10
- Control group: 5
- Site: not specified
- Concentrations: 10% and 5% in polyethylene glycol
- Evaluation (hr after challenge): at 24 and 48 hours
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
4
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation

Maximum concentration not causing irritating effects in preliminary test: 25 %

Signs of irritation during induction:

No erythemas or oedema were observed in animals after topical induction.

Evidence of sensitisation of each challenge concentration:

Positive reactions were observed in all control animals and 7/10 test animals 48 hours after challenge with 25% test substance, there were no positive responses in test or control animals following re-challenge performed one week later, with 10 or 5% test substance.

Other observations: None

Interpretation of results:
other: not sensitizing
Conclusions:
The dermal sensitization potential of test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was assessed in Guinea Pigs. There were no positive responses in test or control animals following re-challenge performed one week later, with 10 or 5% test substance. hence the test chemical was considered as not sensitization to the skin of treated guinea pigs.
Executive summary:

The dermal sensitization potential of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was assessed in Guinea Pigs. The study was performed according to the Guidelines mentioned in Annex V(Maximization).

The maximization test was carried out by using 10 guinea pigs in test group and 5 guinea pigs in control group. During Induction -10 guinea pigs received 5% test chemical in Polyethylene glycol and 5 guinea pigs were used in the negative control group (name not mentioned).After the induction exposure, the guinea pigs were 1st challenged with 25% in polyethylene glycol which lead to a positive response in all control animals and 7/10 test animals at 48 hours, therefore it was considered to be a primary irritant response.

Since positive reactions were observed during challenge phase, animals were re-challenged 7 days later at 10 and 5% test substance.

There were no positive responses or skin sensitizing effects observed in test or control animals following re-challenge performed with 10 or 5% test substance.

Hence, the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) can be considered as not sensitizing at tested concentrations to the skin of guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The dermal sensitization potential of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was assessed in Guinea Pigs. The study was performed according to the Guidelines mentioned in Annex V(Maximization).The maximization test was carried out by using 10 guinea pigs in test group and 5 guinea pigs in control group. During Induction -10 guinea pigs received 5% test chemical in Polyethylene glycol and 5 guinea pigs were used in the negative control group (name not mentioned).After the induction exposure, the guinea pigs were 1st challenged with 25% in polyethylene glycol which lead to a positive response in all control animals and 7/10 test animals at 48 hours, therefore it was considered to be a primary irritant response.Since positive reactions were observed during challenge phase, animals were re-challenged 7 days later at 10 and 5% test substance.There were no positive responses or skin sensitizing effects observed in test or control animals following re-challenge performed with 10 or 5% test substance.Hence, the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) can be considered as not sensitizing at tested concentrations to the skin of guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information, the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS ) was not likely cause any sensitization effects to skin.

Hence, the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS )can be considered as not sensitizing to skin and can be classified under the category “Not Classified” as per CLP.