(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 May 1998 to 25 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A GLP compliant study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

EC Number:

224-815-8

EC Name:

(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

Cas Number:

4501-58-0

Molecular formula:

C10H16O

IUPAC Name:

(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): ALDEHYDE CAMPHOLENIQUE DROIT
- Physical state: colourless liquid
- Storage condition of test material: at room temperature away from light and heat

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: JEGARD, 22120 Yffniac, France
- Weight at study initiation: average weight 2.8 kg
- Diet : complete pelleted rabbit maintenance diet ERGILAP Anco, COFNA (37000 Tours, France)
- Housing: Individual housing on floor grid
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- in accordance with the requirements of 86/609/EEC guideline

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/rabbit

Duration of treatment / exposure:

4 hours

Observation period:

14 days after patch removal

Number of animals:

Three - two males and one female

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze held in place with 5 x 5 cm 'Micropore' fastening tape.
- Type of wrap if used: 10 cm wide stretch tape fastened around the trunk by adhesive tape of the same width.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed using cotton wool moistened with distilled water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The skin was observed at 1, 24, 48 and 72 hours and extended no more than 14 days to establish reversibility. Any irritation was scored using the numerical scale below:

Erythema and eschar formation
No erythema 0
Very slight erythema 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema 4

Oedema formation
No oedema 0
Very slight oedema 1
Slight oedema 2
Moderate oedema 3
Severe oedema 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

2

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: day eight for two animals; very slight erythema seen in one animal at the end of the observation period

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

3

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

2.3

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day eight for two animals; very slight erythema seen in one animal at the end of the observation period

Results 7

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 8

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 9

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Results 10

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Results 11

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Results 12

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

One hour after patch removal, very slight to well defined erythema (scores 1 and 2) and moderate to severe oedema (scores 3 and 4) were seen in all animals. During the following 72 hours of the test, erythema reactions increased in two animals but decreased in one and oedema reactions decreased in all animals.

The reversibility of these reactions was complete for two animals 6 and 8 days after treatment. The remaining animal still had very slight erythema at the end of the observation period.

Other effects:

Structural modifications were observed between days 2 and 3; a cutaneous thickening associated with a dryness of the skin in all animals and a slight loss of skin in one animal.

Any other information on results incl. tables

Table 1: Individual values of skin reactions

	Scores				Mean scores	Scores
Animal number	1 hour (D1)	24 hours	48 hours	72 hours	over 24-72h	D5	D6
Erythema
7255	1	2	2	2	2.0	2	2
7270	1	2	2	2	2.0	2	1
7278	2	2	2	1	1.7	1	1
Oedema
7255	4	3	3	3	3.0	2	2
7270	3	3	2	2	2.3	2	2
7278	3	3	2	1	2.0	1	0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test substance was determined to be a skin irritant.

Executive summary:

In a GLP compliant skin irritation study conducted in line with standardised guideline OECD 404, the skin irritancy of the test substance was determined. Under the conditions of the test, following application of the test substance for four hours under a semi-occlusive patch, very slight to well defined erythema and moderate to severe oedema was seen in all animals. During the following 72 hours, erythema reactions increased in two animals but decreased in one and oedema reactions decreased in all animals. The reversibility of these reactions was complete for two animals 6 and 8 days after treatment and the remaining animal still had very slight erythema at the end of the observation period. The test substance is considered to be a skin irritant.