Cinnamomum zeylanicum, ext.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 June 1987 - 23 June 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted uinder GLP and according to EU Method (Acute Toxicity: Dermal Irritation / Corrosion), 1984. However, chemical identity of substance not reported. Individual scores missing. No 14 day observation period done for reversibility.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

4 rabbits; 7 days observation period

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

4 rabbits; 7 days observation period

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cinnamomum zeylanicum, ext.

EC Number:

283-479-0

EC Name:

Cinnamomum zeylanicum, ext.

Cas Number:

84649-98-9

Molecular formula:

Not Applicable due to UVCB

IUPAC Name:

Cinnamomum zeylanicum, ext.

Constituent 2

Reference substance name:

Cinnamon leaf oil

IUPAC Name:

Cinnamon leaf oil

Details on test material:

- Name of test material (as cited in study report): Cinnamon leaf oil
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: confidential
- Stability under test conditions: no data
- Storage condition of test material: refrigerated at approximately 4°C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. Smith Warlingham, Surrey
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually housed in grid bottomed metal cages
- Diet: antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex), ad libitum
- Water: mains drinking water via automatic nozzles in each cage, available ad libitum
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 48-66
- Air changes (per hr): (air-conditioned)
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours, and 7 days after patch removal

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: approx. 6 sq.cm.
- % coverage: no data
- Type of wrap if used: The lint patches were held in place by encircling the trunk of the animal with a length of 'Elastoplast' elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansed by gentle swabbing with cotton wool soaked in warm water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: The scoring criteria as described by Draize. Erythema and Eschar formation / Oedema formation. Reaction to treatment considered to fall mid-way between the points described was scored as a fraction (i.e. 0.5, 1.5, 2.5, etc).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

4 rabbits

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

4 rabbits

Time point:

24/48/72 h

Score:

ca. 0.4

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritant / corrosive response data:

Well defined erythema and very slight oedema were observed in 2 animals and very slight erythema was apparent at the treated site of the remaining 2 animals 1 hour after dosing.
24 hours after dosing very slight erythema remained in 1animal, very slight to well defined erythema was observed in 2 animals and well defined erythema was noted in the remaining animal. Very slight oedema was observed in this animal and an oedematous score of 0.5 was given to the response observed in 2 animals.
Well defined erythema and very slight oedema were observed in 1 animal at the 48 hour examination. Very slight to well defined erythema was observed in a second animal, a score of 0.5 being given to oedematous reaction in this animal. Very slight erythema was observed in 1 animal and a score of 0.5 was given to erythema observed in the remaining animal at this time.
72 hours after dosing erythematous reaction was maintained in all animals and a score of 0.5 was given to the oedematous reaction remaining in 2 animals. Minimal desquamation was observed from the treated skin of 2 rabbits.
7 days after dosing a score of 0.5 was given to the erythematous reaction remaining in 3 animals, a similar score being given to oedematous reaction in 2 of these animals. Desquamation was observed in 2 animals.

Other effects:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The average scores calculated from the numerical values given to the skin irritation observed at the 24, 48, 72 hour examinations were 1.3 for erythema and 0.4 for oedema. Based on these results and according to EU criteria the material was considered not irritating and the substance does not have to be classified according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

The primary irritation of the skin was measured on the intact skin of 4 albino rabbits, according to EU Method (Acute Toxicity: Dermal Irritation / Corrosion), 1984. The test material (Cinnamon leaf oil) was applied, in 0.5ml aliquots, over an area of approximately 6 sq.cm. on the dorsal skin, clipped free of fur, of 4 albino rabbits. The material was held in contact with the skin under a semi-occlusive dressing for a 4 hour period after which time the patches were removed. Skin reaction to the material was assessed after 1, 24, 48, and 72 hours and 7 days. The final score represents an average of all readings. The scoring and evaluation criteria are those described by Draize. The average scores calculated from the numerical values given to the skin irritation observed at the 24, 48, 72 hour examinations were 1.3 for erythema and 0.4 for oedema. Based on these results and according to EU criteria the material was considered not irritating and the substance does not have to be classified according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).