Cinnamaldehyde

Skin sensitisation

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 a peer-reviewed journal.

Data source

Reference

Reference Type:

publication

Title:

The Sensitization Potential of Some Perfume Ingredients Tested Using a Modified Draize Procedure

Author:

D.W. Sharp

Year:

1978

Bibliographic source:

Toxicology, 9 (1978) 261-271

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Equivalent or similar to OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

not specified

Type of study:

other: Modified Draize test

Justification for non-LLNA method:

No Data Available

Test material

Test material information

Constituent 1

Reference substance name:

Cinnamaldehyde

EC Number:

203-213-9

EC Name:

Cinnamaldehyde

Cas Number:

104-55-2

Molecular formula:

C9H8O

IUPAC Name:

3-phenylacrylaldehyde

Details on test material:

Details on test material
- Name of test material (as cited in study report): Cinnamic aldehyde
- Molecular formula (if other than submission substance): C9H8O
- Molecular weight (if other than submission substance): 132.1612 g/mol
- Substance type: Organic
- Physical state: No data available
Purity: No data available
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Bred in lab colony
- Age at study initiation: No data available
- Weight at study initiation: 350 g
- Housing: During testing they were housed in wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): pelleted guinea pig diet, cabbage, hay ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: No Data Available

Induction 2

Concentration / amount:

Injection challenge concentration: 0.25%
Application challenge concentration: 20%

Challenge

Challenge 1

Route:

intradermal and epicutaneous

Vehicle:

other: No Data Available

Challenge 2

Concentration / amount:

Injection challenge concentration: 0.25%
Application challenge concentration: 20%

No. of animals per dose:

4 males and 6 females or vice-versa
Control animals: Yes, used during the challenge exposure

Details on study design:

Details on study design
RANGE FINDING TESTS: No data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: No data available
- Test groups: 10
- Control group: used
- Site: at 4 sites which overlie the 2 auxillary and 2 inguinal lymph nodes.
- Frequency of applications: Once
- Duration: 14 days
- Concentrations: 4 X 0.1 ml intradermal injections at 2.5 X ICC

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1 day
- Exposure period: 24 hrs
- Test groups: 10
- Control group: At each challenge with controls, 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively.
- Site: intradermally in one flank and topically in the other flank
- Concentrations:
Injection challenge concentration: 0.25%
Application challenge concentration: 20%
- Evaluation (hr after challenge): 24 hrs

OTHER: apparent sensitization reactions were confirmed 7 day later by a second challenge with controls included

Challenge controls:

No Data Available

Positive control substance(s):

not specified

Results and discussion

Positive control results:

No Data Available

In vivo (non-LLNA)

Results

Reading:

other: Sensitizing (after 2 sensitization treatments)

Hours after challenge:

24

Group:

test chemical

Dose level:

Injection challenge concentration: 0.25% Application challenge concentration: 20%

Total no. in group:

10

Clinical observations:

No data available

Remarks on result:

positive indication of skin sensitisation

Remarks:

Reading: other: Sensitizing (after 2 sensitization treatments). . Hours after challenge: 24.0. Group: test group. Dose level: Injection challenge concentration: 0.25% Application challenge concentration: 20% . Total no. in groups: 10.0. Clinical observations: No data available.

Applicant's summary and conclusion

Interpretation of results:

other: The test chemical was considered to be sensitizing.

Conclusions:

Based on all the available data, it was concluded that the test chemical was observed to be a skin sensitizer to guinea pigs at the challenge concentrations tested.

Executive summary:

A modified Draize procedure was used to identify, the test chemical for its potential to induce allergic contact dermatitis in guinea pigs. Induction exposure included intradermal injections at 4 sites with 0.1 mL aliquots of test substance at 2.5 times the ICC. Challenge exposure included intradermal induction (ICC) at a dose of 0.25% and topical application (ACC) at a concentration of 20%. In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, but this time a comfirmatory challenge with controls was included irrespective of any apparent sensitization reactions at the previous challenge. Based on all the available data, it was concluded that the test chemical was observed to be a skin sensitizer to guinea pigs at the challenge concentrations tested.