Reaction mass of (2Z)-5-[(1R,3R,6S)-2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl]-2-methyl-2-penten-1-ol and (2Z)-2-methyl-5-[(1S,2R,4R)-2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl]-2-penten-1-ol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

This report summarizes safety data relevant to the risk assessment of the use of some cyclic and non-cyclic terpene alcohols as fragrance ingredients.

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Studies performed before the adoption of the LLNA test method

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

not specified

Route:

other: not specified

Vehicle:

not specified

Concentration / amount:

10 %

Day(s)/duration:

not specified

Adequacy of induction:

not specified

No.:

#1

Route:

other: not specified

Vehicle:

not specified

Concentration / amount:

10 %

Day(s)/duration:

not specified

Adequacy of challenge:

not specified

No. of animals per dose:

not specified

Details on study design:

not specified

Challenge controls:

Not included.

Positive control substance(s):

yes

Remarks:

Several substances were tested in parallel. Alpha-hexyl cinnamic aldehyde results were included in this ESR as it is one of the preferred positive control substance for GPMT tests.

Positive control results:

See Results table

Key result

Reading:

1st reading

Group:

test chemical

Dose level:

10%

No. with + reactions:

64

Total no. in group:

100

Clinical observations:

not specified

Remarks on result:

positive indication of skin sensitisation

Remarks:

Mild sensitizer: Category II, 29-64% of animals with + reactions (No. with + reactions & total number in group not reported))

Key result

Reading:

1st reading

Group:

positive control

Dose level:

10%

No. with + reactions:

80

Total no. in group:

100

Remarks on result:

positive indication of skin sensitisation

Remarks:

Strong sensitizer: Category IV, 65-80% of animals with + reactions (No. with + reactions & total number in group not reported))

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

Santalol was allergenic in animals.

Executive summary:

Santalol was reported to be positive in a guinea-pig maximisation test when tested at 10 %.

Data source

Reference

Reference Type:

review article or handbook

Title:

A toxicologic and dermatologic assessment of cyclic and non-cyclic terpene alcohols when used as fragrance ingredients

Author:

The RIFM EXPERT Panel (D. Belsito a, D. Bickers b, M. Bruze c, P. Calow d, H. Greim e, J.M. Hanifin f, A.E. Rogers g, J.H. Saurat h, I.G. Sipes i, H. Tagami)

Year:

2008

Bibliographic source:

Food and Chemical Toxicology 46:S1-S71

Materials and methods

Type of sensitisation studied:

skin

Study type:

not specified

Principles of method if other than guideline:

Patch test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer

EC Number:

204-102-8

EC Name:

5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer

Cas Number:

115-71-9

Molecular formula:

C15H24O

IUPAC Name:

5-(2,3-dimethyltricyclo[2.2.1.0~2,6~]hept-3-yl)-2-methylpent-2-en-1-ol

Constituent 2

Reference substance name:

[1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol

EC Number:

201-027-2

EC Name:

[1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol

Cas Number:

77-42-9

Molecular formula:

C15H24O

IUPAC Name:

2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)pent-2-en-1-ol

Test material form:

not specified

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 3123
- Sex: Not specified
- Age: Not specified
- Race: Not specified
- Demographic information: Not specified

Clinical history:

Patients with cosmetic dermatitis

Controls:

Not specified

Route of administration:

dermal

Details on study design:

Patch test / 2% in petrolatum

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 47
- Number of subjects with negative reactions: 3076
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Executive summary:

Patch testing of 3123 patients with cosmetic dermatitis to 2% Santalol in petrolatum resulted in 47 positive reactions (incidence = 1.5%).