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Toxicological information

Skin sensitisation

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Administrative data

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:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
DETERMINATION OF SUITABLE CONCENTRATIONS FOR PATCH TESTING OF VARIOUS FRAGRANCE MATERIALS
Author:
MID-JAPAN CONTACT DERMATITIS Group
Year:
1984
Bibliographic source:
The Journal of Dermatology, 1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Patch test
Principles of method if other than guideline:
Patch test were performed to determine the allergic potential of the test chemical
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Currently no LLNA Study is available for assessment

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol
EC Number:
222-294-1
EC Name:
3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol
Cas Number:
3407-42-9
Molecular formula:
C16H28O
IUPAC Name:
3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexanol
Test material form:
liquid
Details on test material:
- Name of the test material: 3-(5,5,6-Trimethylbicyclo(2.2.1)hept-2-yl)cyclohexanol
- Common Name: Isobornyl cyclohexanol
- IUPAC name: 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexanol
- Molecular formula: C16H28O
- Molecular weight: 236.396 g/mol
- Substance type: Organic
- Smiles: O[C@@H]1CCC[C@@H]([C@@H]2[C@@H]3C[C@@H](C(C)(C)[C@@H]3C)C2)C1

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Patch tested subjects were mostly patients with various facial dermatoses.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: white petrolatum
Concentration / amount:
1,2,10%
Day(s)/duration:
48 or 72 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: white petrolatum
Concentration / amount:
1,2,10%
Day(s)/duration:
48 or 72 jhours
Adequacy of challenge:
not specified
No. of animals per dose:
327
Details on study design:
OTHER: Patch tested subjects were mostly patients with various facial dermatoses. Samples were prepared in 3 different concentrations using white petrolatum as a vehicle.Forty-eight hours closed patch tests were performed using Al-tests or Torii-ban (a domestic product) in 1976, Al-tests, Torii-ban or Finn-chamber in 1977 (4, 10), and only Finn-chamber thereafter. No testing was conducted during the summer seasons. Reactions were read approximately one hour after the removal of the test material (at 48 hours after application) and on the next day (at 72 hours after application), following the ICDRG scoring standard. Any reactions stronger than + by ICDRG reading were counted. Reactions at 72 hours which were rated equal to or stronger than those at 48 hours were assumed to be allergic reactions, while the reverse were deemed irritant reactions. The optimal testing concentration may be the highest concentration never producing an irritant reaction, provided that the allergic reaction produced by that concentration in itself is not too severe to be very harmful to the patient or to his further reactivity (angry back syndrome). The optimal concentrations were thus determined by trying to approximate this ideal concentration. Routine photo patch tests were also performed at the same time on most of the test subjects.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1,2,10%
No. with + reactions:
0
Total no. in group:
327
Clinical observations:
No dermal reactions observed
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Results of the Patch test

Concentration of test chemical in white petrolatum

Reactions

No of patients tested

Allergic

Irritant

10

2.5

0.6

327

2*

1.5

0

327

1

0.6

0

327

*- optimal concentration determined by the study

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.
Executive summary:

The test chemical was patch tested on patients with various facial dermatoses at three different concentrations to determine suitable concentrations for patch testing.The test chemical samples were prepared in 3 different concentrations(1,2,10%) using white petrolatum as a vehicle. Forty-eight hours closed patch tests were performed using Al-tests or Torii-ban (a domestic product) in 1976, Al-tests, Torii-ban or Finn-chamber in 1977 (4, 10), and only Finn-chamber thereafter. No testing was conducted during the summer seasons. Reactions were read approximately one hour after the removal of the test material (at 48 hours after application) and on the next day (at 72 hours after application), following the ICDRG scoring standard. Any reactions stronger than + by ICDRG reading were counted. Reactions at 72 hours which were rated equal to or stronger than those at 48 hours were assumed to be allergic reactions, while the reverse were deemed irritant reactions. The optimal testing concentration may be the highest concentration never producing an irritant reaction, provided that the allergic reaction produced by that concentration in itself was not too severe to be very harmful to the patient or to his further reactivity (angry back syndrome). The optimal concentrations were thus determined by trying to approximate this ideal concentration.Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.