2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-10-08 to 2002-10-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented, according to OECD guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-860-9

EC Name:

-

Cas Number:

474510-57-1

Molecular formula:

C21 H24 O4

IUPAC Name:

2-hydroxy-1-(4-{[4-(2-hydroxy-2-methylpropanoyl)phenyl]methyl}phenyl)-2-methylpropan-1-one

Details on test material:

- Description: Slightly yellow powder
- Purity: 94.1%
- Stability of test item: Stable under storage conditions
- Storage conditions: In the original container, at room temperature (range of 17-23 °C), protected from light. The test item is light sensitive and was handled in a dark room.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes; F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 10 weeks (male); 20 weeks (females)
- Weight at study initiation: male: 2173 g; female: 3018 g (mean)
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water: Community tap water from Fullinsdorf, ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70%
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours light and 12 hours dark

IN-LIFE DATES: From: 08-Oct-2002 To: 17-Oct-2002

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g/0.1 mL

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours (reading performed at 1, 24, 48 and 72 hours)

Number of animals:

3 (animals of both sexes were used)

Details on study design:

TEST SITE
- Area of exposure: 100 cm2 (10 cm x 10 cm)
- % coverage: no data
- Type of wrap if used:semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water to clean the application site
- Time after start of exposure: 4 hours

SCORING SYSTEM: the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

female

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

female

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

male

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

female

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

female

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

- Irritation:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0).
- Corrosion:
No corrosive effects were evident on the skin.

Other effects:

- Viability/mortality/clinical signs:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Coloration:
No irreversible alterations of the treated skin were observed.
- Body weights:
The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

The test item is considered to be "not irritating" to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information