Cinnamomum zeylanicum, ext.

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This publication describes a Guinea Pig Maximisation Test, performed according to methods resembling OECD guideline 406 (ref: Magnusson and Kligman, 1970). It was not indicated if GLP conditions were met in the original study. The study was assigned a Klimisch 2 rating due to the read-across purpose, in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID.

Data source

Reference

Reference Type:

publication

Title:

Evaluation of the sensitizing potential of Eugenol and Isoeugenol in mice and guinea pigs

Author:

J Hilton, RJ Dearman, I Fielding, DA Basketter, I Kimber

Year:

1996

Bibliographic source:

Journal of Applied Toxicology, Vol. 16(5), 459-464 (1996)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

Eugenol

EC Number:

202-589-1

EC Name:

Eugenol

Cas Number:

97-53-0

Molecular formula:

C10H12O2

IUPAC Name:

4-allyl-2-methoxyphenol

Details on test material:

- Name of test material (as cited in study report): Eugenol

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac, Oxon, UK
- Weight at study initiation: approx. 350 g

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: dobs/saline (intradermal) and acetone/PEG (epicutaneous)

Induction 2

Concentration / amount:

Intradermal: 0.1%
Epicutaneous induction: 100%
Epicutaneous challenge: 25%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: dobs/saline (intradermal) and acetone/PEG (epicutaneous)

Challenge 2

Concentration / amount:

Intradermal: 0.1%
Epicutaneous induction: 100%
Epicutaneous challenge: 25%

No. of animals per dose:

10

Details on study design:

RANGE FINDING TESTS:
Preliminary irritation tests were performed to determine suitable assay concentrations.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours (epicutaneous)
- Test groups (n=10): Test article, six intradermal injections and one time epicutaneous application (6-8 days later)
- Control group (n=5): Vehicle only, six intradermal injections and one time epicutaneous application (6-8 days later)
- Site: Shoulder region

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: approx. 14 days after induction
- Exposure period: 24 hours
- Test/control group: Test article epicutaneously at maximum non-irritant concentration
- Evaluation (hr after challenge): 24 hours

C. SCORING SYSTEM
Scoring for erythema on a 0-3 scale

Challenge controls:

Not performed

Positive control substance(s):

no

Results and discussion

Positive control results:

No positive control was included in the study.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100% and 25% test article

No. with + reactions:

3

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% and 25% test article. No with. + reactions: 3.0. Total no. in groups: 10.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

vehicle and 25% test article

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: vehicle and 25% test article. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

A sensitisation rate of 30% was calculated for the guinea pigs exposed to 25% Eugenol in the challenge phase.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information

Conclusions:

Under the conditions of this study, positive skin reactions were noted in 3 out of 10 guinea pigs treated with 25% Eugenol at the challenge phase. A sensitisation rate of 30% was calculated. Based on the threshold value of 30% as mentioned in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC, the substance has to be classified as sensitising.

Executive summary:

This Guinea Pig Maximisation Test (GPMT) was performed to determine the sensitising potential of Eugenol. In the test group (n=10), intradermal induction was performed with 0.1% test article, epicutaneous induction with 100% test article and the final challenge exposure was done with 25% test article. A negative control group (n=5) was also included. Positive skin reactions were scored and sensitisation rates were calculated.

Positive skin reactions were noted in 3 out of 10 guinea pigs treated with 25% Eugenol at the challenge phase (mean score of 0.8). A corresponding sensitisation rate of 30% was calculated. No positive skin reactions were noted in the negative control animals.

Based on the results of this study and considering the threshold value of 30% as mentioned in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC, the substance has to be classified as sensitising.