Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

April 24th, 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2004/73/EC

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-

Cas Number:

809282-20-0

Molecular formula:

C15H25NO2

IUPAC Name:

Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-

Test material form:

solid: crystalline

Details on test material:

white crystalline solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

albino

Details on test animals or test system and environmental conditions:

Three female albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste – F40260 Linxe).
They were kept during a minimal 5-day acclimatisation period.
During the test, the animals weighed between 2.34 and 2.70 kg.

Housing:
Each animal was kept in an individual box installed in a conventional air conditioned animal husbandry; the environmental conditions were:
- Temperature: between 20˚C and 24˚C
- Relative humidity: between 45% and 67%

Food and drink:
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out every six months by the Institut Européen de l’Environnement de Bordeaux (I.E.E.B.).

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

Approximately 24 hours before treatment, the left and right flank were clipped with an electric clipper, from the scapular to lumbar region.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Treatment:
The test item was applied, as supplied, at a dose of 0.5 g, on an undamaged skin of one flank of each animal. The patch was secured in position with a strip of surgical adhesive tape. After the removal of the patch, the treated area was rinsed with distilled water.
On the opposite flank, an untreated area was served as the control.

Duration of treatment / exposure:

The skin reactions were appreciated after 1, 24, 48 and 72 hours after removal of the test item.

Observation period:

The skin reactions were appreciated after 1, 24, 48 and 72 hours after removal of the test item.

Number of animals:

3

Details on study design:

The test item was applied, as supplied, at a dose of 0.5 g, on an undamaged skin of one flank of each animal. The patch was secured in position with a strip of surgical adhesive tape. After the removal of the patch, the treated area was rinsed with distilled water.
On the opposite flank, an untreated area was served as the control.

Initially, one animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.

Macroscopic examination and evaluation of the skin irritation:
The skin reactions were appreciated after 1, 24, 48 and 72 hours after removal of the test item.
This examination consists in assessing the irritant reactions in the treated zone, compared to a control area.
The following sales are used:
Erythema and Eschar formation, scale 0 (no erythema) to 4 (severe erythema – beef redness – with eschars formation preventing grading of erythema)
Oedema, scale 0 (no oedema) to 4 (severe oedema – raised more than 1 mm, and extending beyond area of exposure).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48, and 72 hours).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritating to skin.

Executive summary:

Summary:

The test item T2955 was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the OECD guideline no 404, dated April 24^th, 2002 and the test method B.4 of the directive no 2004/73/EC.

 

No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48, and 72 hours).

 

The results obtained, under these experimental conditions, enable to conclude that the test item T2955 need not to be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the EEC directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.