Methyl (R)-2-(4-hydroxyphenoxy)propionate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl (R)-2-(4-hydroxyphenoxy)propionate

EC Number:

411-950-4

EC Name:

Methyl (R)-2-(4-hydroxyphenoxy)propionate

Cas Number:

96562-58-2

Molecular formula:

C10H12O4

IUPAC Name:

methyl (2R)-2-(4-hydroxyphenoxy)propanoate

Test material form:

solid

Details on test material:

- Appearance: Brown solid
- Storage conditions of test material: Refrigerator

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Male: 3.38 kg; females 2.84 kg
- Housing: Animals were housed individually in cages made of stainless steel with wire mesh walk floors (floor area 40 x 51 cm). There was no bedding in the cages but sawdust in the waste trays
- Diet: About 130 g per animal per day
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % (relative)
- Air changes: Not specified; the animals were housed ln fully air-conditioned rooms
- Photoperiod: 12 hours of light / 12 hours of darkness (lights on 06:00 to 18:00)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3; 1 male and 2 female

Details on study design:

TEST SITE
- Area of exposure: Upper third of the back or flanks. Clipping of the fur took place at least 15 hours prior to the start of the study.
- Type of wrap if used: The solid test material was warmed to 70 °C until liquid. The undiluted material cooled to body temperature was applied to a test patch (2.5 x 2.5 cm) that was secured in position with a porous dressing (four layers of absorbent gauze and porous bandage).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With Lutrol and Lutrol/water (1:1)
- Time after start of exposure: At the end of the 4 hour exposure period

OBSERVATION TIME POINTS
30 to 60 minutes after removal of the patches and 24, 48 and 72 hours after the beginning of the application.

SCORING SYSTEM:
Evaluation of erythema and oedema
0 = None
1 = Very slight
2 = Well defined
3 = Moderate to severe
4 = Severe to very severe

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

An erythema score of 1 was obtained for one of the female rabbits at the 24 hour observation. All other scores for erythema and all oedema scores were 0 at each time point.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the test material was determined to be not irritating to the skin of rabbits.

Executive summary:

The skin irritation potential of the test material was investigated in accordance with the standardised guidelines OECD 404 and EU Method B.4 under GLP conditions.

The undiluted test material was applied to the skin of three New Zealand White rabbits in a semi-occlusive fashion for 4 hours. At the end of the 4 hour exposure period, the test material was removed with Lutrol and Lutrol/water (1:1). Animals were observed 30 to 60 minutes after removal of the patches and after 24, 48 and 72 hours after the beginning of the application and scored for erythema and oedema formation.

An erythema score of 1 was obtained for one of the rabbits at the 24 hour observation. All other scores for erythema and all oedema scores were 0 at each time point.

Under the conditions of this study, the test material was determined to be not irritating to the skin of rabbits.