esterification product of 2-hydroxypropane-1,3-diyl-bis(2-methylprop-2-enoate) and 3-hydroxypropane-1,2-diyl-bis(2-methylprop-2-enoate) and diphosphorus pentoxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 October 2001 to 18 October 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

GLYPHO

IUPAC Name:

GLYPHO

Details on test material:

- Name of test material (as cited in study report:GLYPHO
- Substance type:Yellowish liquid
- Physical state:Liquid
- Lot/batch no.:AH2/170
- Expiration date of the lot/batch:01 February 2002
- Storage condition of test material:In the original container, in the refrigerator, away from direct sunlight.

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:16-17 weeks (male), 14-16 weeks (females)
- Housing: Individually
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees C
- Humidity (%):30-70
- Air changes (per hr):10-15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 08 Oct 2001 To: 18 Oct 2001

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

1 male, 2 females

Details on study design:

TEST SITE
- Area of exposure: Flanks, 6 square cm
- Type of wrap if used: Semi occlusive dressing anchored with tape
SCORING SYSTEM:Erythema 0-4/Oedema 0-4

Results and discussion

In vivo

Results

Irritation parameter:

other: Skin Irritation Score

Basis:

other: Mean scores for irration and oedema

Time point:

other: 24, 48, 72 hours

Score:

ca. 0 - ca. 1

Reversibility:

fully reversible

Remarks on result:

other: No abnormal findings were observed at the test site of any animal 72 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EEC Commission Directive 93/21/EEC of April 27, 1993

Conclusions:

Based on the results of the study, the test article is a mild dermal irritant.

Executive summary:

The primary skin irritation potential of the test article was evaluated in New Zealand White rabbits. This study was performed in accordance with Swiss GLP (2000) and OECD GLP (1997). The study design was based on the following guidelines: OECD 404 (1992) and Directive 92/69 EEC, B.4 (1992). Only 1 female rabbit was initially tested as the test article was suspected to produce irritancy. At a concentration of 10% of the test article in purified water, the pH was found to be 1.72. The hair was clipped from the dorsal skin of the rabbit. The test material (0.5 mL) was placed on a 2.5 x 2.5 cm gauze patch and was applied to the intact skin of the clipped area. The torso was wrapped with a dressing in a semi-occlusive manner and secured with non-irritating tape. Three patches were applied to three different intact sites for a 3 minute, 1 hour, or 4 hour exposure, respectively. Since no severe irritation was observed, a test article patch was placed on each of the remaining 2 animals (1 male, 1 female) following the aforementioned protocol, for a 4-hour exposure. Observations for skin irritation (erythema and edema) were recorded at 1, 24, 48 and 72 hours. Skin observations were also recorded at 7 days for the first treated female. The skin irritation score was calculated. Following the 3 minute and 1 hour applications, erythema (score: 1) was observed immediately after unwrapping and at 1 hour postdose but cleared by 24 hours postdose. No edema was observed following 3 minute and 1 hour exposures. At 1, 24, and 48 hours post 4 hour exposures, erythema (scores: 2, 2, 1, respectively) and edema (scores: 2, 2, 0, respectively) were observed in the initially treated female. All skin reaction scores for the other animals were 0 throughout the study. The individual mean scores (24-72 hours) for erythema were 0.0, 1.0, and 0.0. The individual mean scores (24-72 hours) for edema were 0.0, 0.67, and 0.0. The PII was 0.56/8.0. Based on the results of this study, the test article is a mild dermal irritant.