(2,5-dimethyl-2,3-dihydro-1H-inden-2-yl)methanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 18 to 28, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline 404 without any deviation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

inspected on September 22, 1999 / signed on January 18, 2000

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

437-760-1

EC Name:

-

Cas Number:

285977-85-7

Molecular formula:

C12H16O

IUPAC Name:

(2,5-dimethyl-2,3-dihydro-1H-inden-2-yl)methanol

Test material form:

solid

Details on test material:

- Physical state: White solid (but some samples were received as liquid, due to stability in supercooled state)
- Storage condition of test material: At room temperature, protected from light and under nitrogen atmosphere

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: No data available
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: Animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: 112 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30–70%
- Air changes: Approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: January 18, 2000 To: January 28, 2000

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: moistened with water

Controls:

other: untreated skin served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 500 mg (ground to a fine powder using a mortar and pestle)
- Purified water was used to moisten the test substance and ensure good contact with the skin

Duration of treatment / exposure:

4 hours

Observation period:

Observations at 1, 24, 48 and 72 hours and daily as needed up to 14 days after removal of the dressing.

Number of animals:

3 male animals

Details on study design:

TEST SITE
- Area of exposure: Right flank
- % coverage: no data available
- Type of wrap if used: The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the dressing, any residual test substance was wiped off by means of a dry gauze pad.
- Time after start of exposure: 4 hours

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

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

probability of weak irritation

Remarks:

A well-defined erythema (score 2) was noted on Day 1, then a very slight erythema (score 1) persisted up to Day 5. Dryness of the skin was recorded between Day 6 and Day 10

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

probability of weak irritation

Remarks:

A very slight erythema was observed on Day 1 and 2 only

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

In one animal, a well-defined erythema (grade 2) was noted on day 1, then a very slight erythema (grade 1) persisted up to day 5. Dryness of the skin was recorded between day 6 and day 10.
In a second animal, a very slight erythema (grade 1) was observed on days 1 and 2 only.
No cutaneous reactions were observed in the third animal.

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

 

Score at time point	Erythema (Animal no 1 / 2 / 3) Max. score 4	Oedema (Animal no 1 / 2 / 3) Max. score 4
1 h (D1)	2 / 1 / 0	0 / 0 / 0
24 h (D2)	1 / 1 / 0	0 / 0 / 0
48 h (D3)	1 / 0 / 0	0 / 0 / 0
72 h (D4)	1 / 0 / 0	0 / 0 / 0
D5	1 / - / -	0 / - / -
D6	0 / - / -	0 / - / -
D7	0 / - / -	0 / - / -
D8	0 / - / -	0 / - / -
D9	0 / - / -	0 / - / -
D10	0 / - / -	0 / - / -
D11	0 / - / -	0 / - / -
Average 24, 48 and 72 h	1.0 / 0.3 / 0.0	0.0 / 0.0 / 0.0

 

-:Cutaneous examination not performed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

Under the test conditions, test material is not classified as irritating to skin according to the annex I of the Regulation EC No. 1272/2008 (CLP) and of the GHS.

Executive summary:

In a primary dermal irritation study performed according to the OECD Guideline No. 404/EU Method B.4, and in compliance with GLP, 500 mg of test material moistened with purified water was applied on the clipped skin of the right flank area of 3 male New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 h. The untreated skin served as control. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions.

 

In one animal, a well-defined erythema was noted on day 1, then a very slight erythema persisted up to day 5. Dryness of the skin was recorded between day 6 and day 10. In a second animal, a very slight erythema was observed on days 1 and 2 only. No cutaneous reactions were observed in the third animal. Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.3 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.

 

Therefore, test material is not classified as irritating to skin according to the annex I of the Regulation EC No. 1272/2008 (CLP) and of the GHS.

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