2-methoxy-4-(methoxymethyl)phenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

The skin irritation in vivo (according to OECD TG 404) was performed before the new guidelines were initiated.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was carried out between 28 November and 9 December 2005.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxy-4-(methoxymethyl)phenol

EC Number:

226-882-9

EC Name:

2-methoxy-4-(methoxymethyl)phenol

Cas Number:

5533-03-9

Molecular formula:

C9H12O3

IUPAC Name:

2-methoxy-4-(methoxymethyl)phenol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

other: SPF albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: stock Chbb:HM from Charles River Deutschland GmbH, D-88353 Kisslegg
- Age at study initiation: 7-18 months
- Weight at study initiation: 2.3 - 2.8 kg bw
- Housing: During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 sq. cm) with perforated floor.
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants were performed.
- Water: The animals had free access to bottles with dometic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants were performed.
- Acclimation period: At least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: at least 30 % and not exceeding 70%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Test material
- Applied volume: 0.5 ml
- Concentration: undiluted

Duration of treatment / exposure:

4-hour exposure period

Observation period:

After the exposure, the observation was performed immediately and at 1h, 24 h, 48 h and 72 h.

Number of animals:

A total of 3 animals were used, treated with the test substance.

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Coverage: The test item was applied on a 16-layer gauze patch and put on an animal. Adhesive Gothaplast tape (2.5 cm and 5 cm wide) served as the semi-occlusive securing.

REMOVAL OF TEST SUBSTANCE
- Washing: After the period of 4 hours of exposure, the patch was removed and the treated skin was cleaned with mild soap and lukewarm water.

SCORING SYSTEM:
- Method of calculation: erythema and oedema formation were scored and the mean values for both were calculated

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: immediately after application

Score:

1

Reversibility:

fully reversible within: 24 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 24 h

Results 3

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: immediately after application and after 1h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

All three rabbits at the readings of 24, 48 and 72 h were free of any signs of skin irritation. The mean individual erythema scores were 0 for all three rabbits. Also the mean individual oedema scores were 0 for all three rabbits.
Only one rabbit showed reaction immediately after the termination of exposure. It was a very slight erythema and it remained until 1 h after termination of exposure.

Other effects:

No other effects were noted:
- No acute clinical symptoms were observed
- No mortality occurred
- No adverse effect on the body weight gain was observed

Any other information on results incl. tables

Rabbit no.	Exposure	Erythema formation						Oedema formation
		0	1	24	48	72		0	1	24	48	72
3104	3 min	0	0	0	0	0		0	0	0	0	0
	1 h	0	0	0	0		0	0	0	0	0	0
	4 h	1	1	0	0		0	0	0	0	0	0
3300	4 h	0	0	0	0		0	0	0	0	0	0
3297	4 h	0	0	0	0		0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

According to EU CLP 1272/2008 and its amendments.

Conclusions:

In a skin irritation study with rabbits, performed according to OECD 404 (2005), the substance was not irritating.

Executive summary:

The substance was tested in a skin irritation test in 3 rabbits in accordance with OECD TG 404 (2005) test guideline. No irritation was observed: the mean value for both erythema and edema from gradings at 24, 48 and 72 hours after patch removal was 0 in all animals. This effect does not result in classification and labelling for EU CLP.