5-methyl-2-(1-methylvinyl)cyclohexan-1-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Remarks:

Test substance represents a main component (stereoisomer) of the registered substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP, short study report with inconsistencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

Guinea Pig Maximisation Test

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study was performed before LLNA was formally validated and available as OECD guideline in 2002.

Test material

Test material information

Constituent 1

Reference substance name:

Isopulegol

EC Number:

201-940-6

EC Name:

Isopulegol

Cas Number:

89-79-2

Molecular formula:

C10H18O

IUPAC Name:

(1R,2S,5R)-2-Isopropenyl-5-methylcylohexanol

Details on test material:

Test Item: Isopulegol
no further data

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 309-416 g
- Age at study initiation: 6 months

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

other: propyleneglycol plus acetone (1:1)

Concentration / amount:

Intradermal induction: 10%
Epicutaneous induction: 10%

Challenge

Route:

other: epicutaneous (unspecified)

Vehicle:

other: propyleneglycol plus acetone (1:1)

Concentration / amount:

Epicutaneous challenge: 40, 20, 10, 5%

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS: sighting tests were performed for test substance concentration selection. No further data


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: no data
- Test groups: intradermal (10% in Complete Adjuvant + 10% in a mixture of Freund´s Complete Adjuvant and phys. saline (1:1)) topical (10% in Complete Adjuvant)
- Control group: yes, no further data on treatment
- Site: back


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: no data
- Exposure period: 24h
- Test groups: 40, 20, 10, 5% in propyleneglycol/acetone
- Control group: yes, no further data on treatment
- Site: back
- Evaluation (hr after challenge): 24h

OTHER:
Hair was cut with an electric hair clipper and electric shaver
Scoring of dermal reactions acc. to Draize

Challenge controls:

yes

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

40%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

40%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

The test item produced a sensitisation index of 0 (0/5) in all concentrations tested up to 40% and was classified as a non-sensitiser to guinea pig skin at a maximum concentration of 40%. Accordingly , no reactions were noted at the challenge site of control group animals.

In the test report, the sensitization rate has been described as 0% (0/10), however only 5 animals have been tested per dose group.