Cinnamaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Data is from experimental study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The objective of the study was to assess the irritant and/or corrosive effects of test chemical after topical application on the intact skin in Rabbits.

GLP compliance:

no

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

Test material form:

liquid

Details on test material:

-- Name of test material: 2-Propenal-3-phenyl
- Molecular formula: C9H8O
- Molecular weight: 132.16 g/mol
- Smiles notation: c1(ccccc1)/C=C/C=O
- InChl: 1S/C9H8O/c10-8-4-7-9-5-2-1-3-6-9/h1-8H/b7-4+
- Substance type: organic
- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Institute for Industrial Research &Toxicology
- Age at study initiation:10 to 12 weeks
- Weight (Prior to Treatment):2.0kg±200g
- Accommodation:Animal was housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
- Diet (e.g. ad libitum):Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi
- Water (e.g. ad libitum):Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum
- Acclimation period:The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-25°C
- Humidity (%):40-60%
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12:12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hrs.

Observation period:

60 min., 24, 48 and 72 hours after application.

Number of animals:

1

Details on study design:

TEST SITE
- Area of exposure:The dorsal area of trunk
- % coverage:approximately 6 cm2.
- Type of wrap if used:impervious dressing which was secured in position with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done):The residual test item was removed by using lukewarm water.
- Time after start of exposure:no data
SCORING SYSTEM:Draize Method

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

3.25

Reversibility:

no data

Remarks on result:

other: moderately irritant to skin of the New Zealand white rabbits

Irritant / corrosive response data:

The test compound when applied at the dose level of 0.5 ml on shaven back skin of rabbit produced focal necrotic areas, erythema and edema after four hours of patch removal. The test compound also produced deep injury to skin.

Other effects:

The test compound applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity.

Any other information on results incl. tables

INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES

 

Rabbit No.	Sex	INTACT SKIN
		3 Min.		4 Hours		24 Hours		48 Hours		72 Hours		14 days
		Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
01	F	0	0	4	2	2	1	2	1	2	0	0	0
Total		0	0	4	2	2	1	2	1	1	0	0	0
Mean		0	0	4	2	2	1	2	1	1	0	0	0
Grand Total		13.00

 

Dermal Irritation Index: 13.0/4 = 3.25

CLINICAL SIGNS

SEX	ANIMAL NO.	Time (Min.)	Time (Hours)
		3	1	4	24
FEMALE	01	N	N	N	N

N: No Clinical Signs

C: Clinical Signs Observed

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Conclusions:

The dermal irritation index for test chemical was calculated as 3.25.Thus considering this irritation index score it is concluded that the test chemical is moderately irritant to skin of rabbit.

Executive summary:

The Acute Dermal Irritation study of test chemical was conducted on New Zealand white rabbit in accordance with OECD 404 to assess the irritation parameter of the test chemical.In the initial test one healthy rabbit of body weight 2.12kg selected for study after acclimatization. The test compound in the amount of 0.5 ml was applied at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm²) one day earlier before the treatment.The site of application was covered with impervious dressing secured in position with adhesive tape. The first patch was applied on the shaven back skin of rabbit and removed after three minutes. No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour. Focal necrotic areas, erythema and edema were observed at the site of application at moderate level. The test was terminated after three sequential exposures due to corrosive effect of test compound.The test compound when applied at the dose level of 0.5 ml on shaven back skin of rabbit produced focal necrotic areas, erythema and edema after four hours of patch removal. The test compound also produced deep injury to skin. The test compound applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity.Hence,The test compound applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity.