(3-methoxy-2-methylpropyl)benzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 04 to 13, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

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:

[(2S)-3-methoxy-2-methylpropyl]benzene

Molecular formula:

C11H16O

IUPAC Name:

[(2S)-3-methoxy-2-methylpropyl]benzene

Constituent 2

Reference substance name:

[(2R)-3-methoxy-2-methylpropyl]benzene

Molecular formula:

C11H16O

IUPAC Name:

[(2R)-3-methoxy-2-methylpropyl]benzene

Test material form:

liquid

Details on test material:

- Physical state: Colourless liquid

Specific details on test material used for the study:

- Storage condition of test material: Stored at room temperature, away from the light and heat.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BERTHO, 22120 Yffiniac, France
- Weight at study initiation: 2.3 kg (average weight)
- Housing: Animals were housed individually on floor grids.
- Diet: Complete pelleted rabbit maintenance diet Energie H326 (COFNA, 37000 - Tours, France)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS: Environmental conditions and controls were in accordance with the requirements of the 86/609/EEC guideline.

IN-LIFE DATES: From: August 04, 1997 To: August 13, 1997.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 h after patch removal and then on Days 5, 6, 7, 8 and 9.

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the trunk
- Type of wrap if used: Test material was applied to the clipped skin and covered with a gauze (2.5 x 2.5 cm) held in place by means of a 5 x 5 cm wide "Micropore" fastening tape. Then the animal's trunk was wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width and placed in such a way so as not to hinder respiratory movements.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed using absorbent paper moistened with distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scale, as described in OECD Guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 9 day

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- Formation of erythema and oedema of index 1 (in 1 animal) or index 2 (in 2 animals) were observed at 1 h after patch removal.
- At 24 h observation, 2 animals exhibited a well-defined erythema with barely visible oedema, and a very slight erythema was noted in the third animal.
- A very slight or well defined erythema was noted in the two animals and no cutaneous reaction was observed in the third animal after 48 h.
- Observed oedematous and erythematous reactions were completely disappeared within 72 h and 9 days respectively.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test

Score at time point	Erythema (Animal no 1 / 2 / 3) Max. score 4	Oedema (Animal no 1 / 2 / 3) Max. score 4
1 h	2 / 2 / 1	2 / 2 / 1
24 h	2 / 2 / 1	1 / 1 / 0
48 h	2 / 2 / 1	0 / 1 / 0
72 h	1 / 2 / 0	0 / 0 / 0
Day 5	1 / 2 / -	0 / 0 / -
Day 6	1 / 2 / -	0 / 0 / -
Day 7	1 / 2 / -	0 / 0 / -
Day 8	1 / 1 / -	0 / 0 / -
Day 9	0 / 0 / -	0 / 0 / -
Average 24, 48 and 72 h	1.7 / 2.0 / 0.7	0.3 / 0.7 / 0.0
Reversibility	Completely reversible	Completely reversible
Average time for reversion	9 days	72 h

Key:

- : No reading

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Under the test conditions, test material is not classified as irritant to the skin according to the criteria of the Annex VI of Regulation (EC) No. 1272/2008 (CLP) but is classified as mild irritant (Category 3) according to the GHS.

Executive summary:

In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of the test material was applied on the clipped skin of three male New Zealand White rabbits. The test material was held in contact with the skin by means of a semi-occlusive dressing for 4 h. Skin reactions were assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after removal of the dressing and on Days 5, 6, 7, 8 and 9.

Formation of erythema and oedema of score 1 (in 1 animal) or score 2 (in 2 animals) were observed at 1 h after patch removal. At 24 h observation, 2 animals exhibited a well-defined erythema with barely visible oedema, and a very slight erythema was noted in the third animal. A very slight or well defined erythema was noted in the two animals and no cutaneous reaction was observed in the third animal after 48 h. Observed oedematous and erythematous reactions had completely disappeared within 72 h and 9 days respectively.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.7 / 2.0 / 0.7 for erythema and 0.3 / 0.7 / 0.0 for oedema.

Under the test conditions, test material is not classified as irritant to the skin according to the criteria of the Annex VI of Regulation (EC) No. 1272/2008 (CLP) but is classified as mild irritant (Category 3) according to the GHS.

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