2-Propenoic acid, 2-methyl-, 2-(4-benzoyl-3-hydroxyphenoxy)ethyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in accordance with the OECD guideline 404 (adopted 17 July 1994) and in compliance with GLP (incl. certificate).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-benzoyl-3-hydroxyphenoxy)ethyl 2-methylprop-2-enoate

Cas Number:

16613-04-0

Molecular formula:

C19 H18 O5

IUPAC Name:

2-(4-benzoyl-3-hydroxyphenoxy)ethyl 2-methylprop-2-enoate

Details on test material:

- Name of test material (as cited in study report): ULS-611
- Physical state: cream coloured solid
- Analytical purity: no data given
- Impurities (identity and concentrations): no data given
- Lot/batch No.: I 1608X
- Storage condition of test material: ambient temperature (< 25 °C), under artificial light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.38-2.64 kg
- Housing: individual in suspended metal cages
- Diet (ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19 °C
- Humidity (%): 49-56 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g ULS-611, moistened with 0.5 ml distilled water

Duration of treatment / exposure:

4 hours

Observation period:

Skin changes were recorded 1 h, 24 h, 48 h and 72 h after removal of the patches.

Number of animals:

3

Details on study design:

On the day before the test, each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers.
On the day of the test, the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch, placed in position and secured with a strip of surgical adhesive tape (BLENDERM: ca. 2.5 cm x 4.0 cm). The trunk of each rabbit was wrapped in an elastic corset (CUBIGRIP) and the animals were returned to their cages during the exposure period.
4 hours after application, the corset and patches were removed. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
Approximately 1 hour after removal of the patches and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the method of Draize (Draize JH, 1977, "Dermal and Eye Toxicity Tests" in: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC, p. 31).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all animals

Time point:

other: 24-48-72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all animals

Time point:

other: 24-48-72 h

Score:

0

Irritant / corrosive response data:

No evidence of skin irritation and no corrosive effects were noted during the study.