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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:
14 June to 12 July 2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
study conducted according to OECD 404 Guideline - supposed to be GLP but not specified - with acceptable deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Deviations: information on animals, environmental conditions and method not reported
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Deviations: information on animals, environmental conditions and method not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Remarks:
supposed to be GLP but not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene
EC Number:
220-585-8
EC Name:
(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene
Cas Number:
2825-82-3
Molecular formula:
C10H16
IUPAC Name:
(1R,2S,6R,7S)-tricyclo[5.2.1.0^{2,6}]decane
Test material form:
liquid
Details on test material:
- Physical appearance: colourless liquid
- Storage conditions: at room temperature
Specific details on test material used for the study:
Date of receipt: 08 June 2005

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: not specified
- Weight during study: 2.30-3.09 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: not specified
- Water: not specified
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature: 18-23 °C
- Humidity: 53-68 %
- Air changes: not specified
- Photoperiod: not specified
IN-LIFE DATES: 14 June -12 July 2005

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: On the opposite flank an untreated area was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted
Duration of treatment / exposure:
supposed to be 4 h
Observation period:
Skin reactions were appreciated 1, 24, 48 and 72 h & Days 4 to 14 after removal of the patch.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: undamaged skin area of the right flank of each animal.
- Type of wrap if used: The patch was secured in position with an extensible adhesive tape.
- Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.

SCORING SYSTEM: According to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
A moderate erythema associated to a moderate to severe oedema waere noted in the treated area 24 hours after exposure. These reactions are fully reversibles within Day 6 or 8.
Regarding the cutaneous structure, the skin become totally undamaged at Day 15 in one animal but a slight dryness is still noted in the remaining animals at the end of the observation period.
Other effects:
None

Any other information on results incl. tables

Table 7.3.1/1: Individual and average scores

Observations Scores
Skin reactions Observation time Animal no. A6723 (#1) Animal no. A6772 (#2) Animal no. A6773 (#3)
Erythema and eschar 1h 2 2 2
24h 2 2 2
48h 3 2 2
72h 3 3 3
4 d 3 3 3
5d 0 3 3
6d 0 0 0
7d 0 0 0
8d 0 0 0
9d 0 0 0
10d 0 0 0
11d 0 0 0
12d 0 0 0
13d 0 0 0
14d 0 0 0
Mean 24/48/72 h 2.7 2.3 2.3
Oedema 1h 4 3 2
24h 3 2 2
48h 2 2 2
72h 2 2 2
4 d 2 2 2
5d 0 2 2
6d 0 1 1
7d 0 0 0
8d 0 0 0
9d 0 0 0
10d 0 0 0
11d 0 0 0
12d 0 0 0
13d 0 0 0
14d 0 0 0
Mean 24/48/72 h 2.3 2.0 2.0

A6723: slight dryness from D3 to D4 and from D11 to D13; dryness from D9 to D10, loss of skin elasticity from D5 to D8

A6772: slight dryness from D12 to D14; dryness from D2 to D5 and at D11, loss of skin elasticity from D6 to D10

A6773: slight dryness from D13 to D14; dryness from D2 to D5 and from D11 to D12, loss of skin elasticity from D6 to D10

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the test conditions, the test substance is classified as skin irritation Category 2 (H315: Causes skin irritation) according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and as Category 2 "irritant" according to the GHS.
Executive summary:

In a dermal irritation study performed according to the OECD Guideline No. 404, 0.5 mL of undiluted test item was applied on the undamaged skin of the right flanks of 3 male New Zealand White rabbits. On the opposite flank an untreated area was served as the control. Test sites were covered with a extensible adhesive tape for 4 h. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h and day 4 to 14 after the removal of the patch. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated during 4 hours.

 

A moderate erythema associated to a moderate to severe oedema waere noted in the treated area 24 hours after exposure. These reactions are fully reversibles within Day 6 or 8.

Regarding the cutaneous structure, the skin become totally undamaged at Day 15 in one animal but a slight dryness is still noted in the remaining animals at the end of the observation period.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 2.7 / 2.3 / 2.3 for erythema and 2.3 / 2.0 / 2.0 for oedema.

Under the test conditions, test substance is classified as skin irritation Category 2 (H315: Causes skin irritation) according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and as Category 2 "irritant" according to the GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.