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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 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
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
2.3
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 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
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
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.