(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene

Skin irritation / corrosion

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 guideline

Test guideline 1

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

Test guideline 2

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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:

probability of mild irritation

Results 5

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:

positive indication of irritation

Results 6

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:

probability of mild 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 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 were 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.