Cinnamomum cassia, ext.

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

ECHA Guidance Chapter R.7a (2017) describes that substances with a positive result in an open epicutaneous test may be considered as a potential skin sensitiser.

Data source

Reference

Reference Type:

publication (copyright not owned for reproduction)

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: allergenicity assessment
- Short description of test conditions: Three consecutive phases. 1) Pretesting phase: establisching the primary irritating threshold concentration of test substances. Provides the baseline data for each material to be tested on guinea pigs. 2) Induction phase: 3-week period of daily open applications of the test material, usually to the same skin site. 3) Challange phase: determination whether sensitization has occurred or not.
- Parameters analysed / observed: minimal irritating and maximal nonirritating concentration both determined by all-or-none criteria

GLP compliance:

not specified

Type of study:

open epicutaneous test

Justification for non-LLNA method:

The LLNA method (developed in 1989) was not available yet by the time the study was conducted (1985).

Test material

Test material information

Constituent 1

Reference substance name:

Cinnamomum cassia, ext.

EC Number:

284-635-0

EC Name:

Cinnamomum cassia, ext.

Cas Number:

84961-46-6

IUPAC Name:

(2E)-3-(2-methoxyphenyl)prop-2-enal; (2E)-3-phenylprop-2-en-1-yl acetate; (2E)-3-phenylprop-2-enal

Test material form:

liquid

Remarks:

Yellow colour

In vivo test system

Test animals

Species:

guinea pig

Sex:

male/female

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, open

Vehicle:

not specified

Concentration / amount:

100%, 30%, 10%, 3%,1% and 0,3%

Day(s)/duration:

Day 0-20

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, open

Vehicle:

not specified

Concentration / amount:

A: minimal irritating concentration
B: A/3 maximal nonirritating concentration
C: B/3
D: C/3

Day(s)/duration:

21-35

Adequacy of challenge:

not specified

No. of animals per dose:

10 (controls), min 6 (in test groups)

Details on study design:

RANGE FINDING TESTS:
- Timepoint: 1 day before starting the induction procedure
- No. of exposures: 1
- Amount: 0.025 ml
- Concentrations: 100, 30, 10, 3 and 1% simultaneously
- Site: 2 cm2 of the flank skin (clipped and marked with a circular stamp)
- Evaluation: 24h after application of the test material

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 20/21 (daily for 3 weeks or 5 times weekly during 4 weeks)
- Exposure period: -
- Test groups: TS in vehicle
- Control group: No pretreatment or Vehicle
- Site: 8cm2 on the flank skin (uncovered)
- Frequency of applications: daily for 3 weeks or 5 times weekly for 4 weeks
- Duration: 0-20 d
- Concentrations: 100%, 30%, 10%, 3%, 1% and 0,3%

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 and 35
- Exposure period: -
- Test groups: TS in vehicle
- Control group: TS in vehicle
- Site: contralateral flank
- Concentrations: 4 different; named A, B, C, D
- Evaluation (hr after challenge): 24, 48, 27

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Group:

positive control

Remarks on result:

not measured/tested

Results 2

Group:

negative control

Remarks on result:

not measured/tested

Results 3

Key result

Reading:

other: not specified

Group:

test chemical

Dose level:

results very concise and only qualitative

Remarks on result:

positive indication of skin sensitisation

Remarks:

OET

Results 4

Key result

Reading:

other: not specified

Group:

test chemical

Dose level:

4%

Remarks on result:

positive indication of skin sensitisation

Remarks:

in HMT/RIPT is mentioned in this publication but is not described in detail

Applicant's summary and conclusion

Interpretation of results:

other: Substance is a potential skin sensitiser

Conclusions:

Cassia oil tested positive in human (4% in HMT/RIPT) and guinea pigs (OET) sensitisation tests.

Executive summary:

Cassia oil was found to be sensitising in human (4% in HMT/RIPT) and guinea pigs (OET) and is therefore considered to be a potential skin sensitiser.