2-Propenoic acid, polymer with 2,2-bis(hydroxymethyl)-1,3-propanediol, 2-methyloxirane and oxirane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 18 to 21 January 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study (B4 Method)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid

IUPAC Name:

2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid

Constituent 2

Reference substance name:

Reaction products of (1 mole) Pentaerythritol ethoxylated and propoxylated (4:1) with 2-propenoic acid (4 moles)

EC Number:

604-394-0

Cas Number:

144086-02-2

Molecular formula:

C17H28O12 (C3H6O.C2H4O)n

IUPAC Name:

Reaction products of (1 mole) Pentaerythritol ethoxylated and propoxylated (4:1) with 2-propenoic acid (4 moles)

Test material form:

other: liquid

Details on test material:

- Lot/batch No.: ZJ600
- Expiration date of the lot/batch: January 1995
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 11-14 weeks old
- Weight at study initiation: 2.4 to 3.2 kg
- Housing: individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): standard Iaboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes but no detail

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by means of a time switch to give 12 hours of artificial Iight (0700 - 1900 hours) in each 24 hours period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A 0.5 ml amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

Duration of treatment / exposure:

4 hours

Observation period:

Examination of the treated skin was made on Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).

Number of animals:

3 rabbits

Details on study design:

Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-Iumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
All animals were observed daily for signs of ill health or toxicity.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 rabbits

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

4

Remarks on result:

other: No erythema was observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 rabbits

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

4

Remarks on result:

other: No oedema was observed

Irritant / corrosive response data:

No dermal irritation was observed.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A single semi-occlusive application of 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid to intact rabbit skin for four hours elicited no dermal irritation. According to these study, 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid is not irritating for skin in rabbits.

Executive summary:

A study was performed to assess the skin irritation potential of 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid to the rabbit (Method B.4.). Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for four days. There were no signs of toxicity or ill health in any rabbit during the observation period. No dermal reactions were observed following a single semi-occlusive dermal application of 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid to intact rabbit skin for four hours. 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid does not require labelling as lrritating to skin.