reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November - December 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole)

EC Number:

821-997-6

Cas Number:

2136366-99-7

Molecular formula:

C11H16O6 to C21H32O8

IUPAC Name:

reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole)

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Highgate farm, market Rasen, Lincolnshire, England.
- Age at study initiation: at least 9 weeks
- Weight at study initiation: 2.5-2.8 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: > 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19+/-2
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Approximately 0.5 ml of the test substance was applied under a 2-ply 25 mm x 25 mm porous gauze pad to each intact skin site on each animal.

Duration of treatment / exposure:

32 min, 60 min, 4h

Observation period:

Examination of the treated skin was made on Day 1 (ie immediately after removal of the dressings following the three minute and one hour exposure or approximately 60 minutes after removal of the dressings following the four hour exposure) and on Day 2, 3 and 4 (equivalent to approximately 24, 48 and 72 hours after exposure). Additional observations were made for all animals on Days 5 and 6, for 2 animals on Day 7 and for one animal on Day 8 through 12.

Number of animals:

3

Details on study design:

Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
To help to clarify the irritant potential of the test substance, initially only one animal was treated. With this animal, the test substance was applied to 3 treatment sites and the exposure period was varied between treatment sites. On the basis of initial results from this phase of the study, 2 further animals were exposed to the test substance for 4 hours.
Each treatment site was covered with Elastoplast elastic adhesive dressing for up to 4 hours. only during the 3 minute exposure period was the initial animal restrained. For the 60 minute and 4 hour expsure, none of the animals were restrained but were returned to their cages immediately after treatment.
At the end of the exposure periods, the semi-occlusive dressing and gauzer pad were removed and the treatment sites washed with warm water (34-37°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper

All animals were observed daily for signs of ill health or toxicity.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(4h exposure)

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

1.43

Max. score:

4

Reversibility:

fully reversible within: 12 days

Remarks on result:

other: Mean individual scores: 1.3-2-1

Results 2

Irritation parameter:

edema score

Remarks:

(4h exposure)

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0.87

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: Mean individual scores: 0.3-1.3-1

Irritant / corrosive response data:

Very slight erythema was elicited from Day 2 following a single semi-occlusive application of test material to intact skin for 3 and 60 minutes. reactions had resolved completely by Day 4 and 3, respectively.
Very slight to well-defined erythema with slight oedema was observed in all 3 animals following the 4 hour exposure. reactions were first noted approximately an hour after bandage removal and had resolved completely by either Day 6, 7 or 12.
The mean scores for these reactions at approximately 24, 48 and 72 hours after administration, calculated separately for each animal are : 1.3, 2 and 1 for erythema, and 0.3,1.3 and 1 for oedema.

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:

GHS criteria not met

Remarks:

Not skin irritating.

Conclusions:

Based on these results, the test material is considered to be slightly skin irritating.

Executive summary:

A study was performed to assess the skin irritation potential of test material to the rabbit. The method foolowed was that described in OECD test guideline n°404.

Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance an observed for up to 12 days. The effects of a 3 minutes, 60 minutes and 4 hours exposure were initially investigated using a screen animal.

Very slight dermal irritation was elicited following a single semi-occlusive application of test material to intact rabbit skin for 3 and 60 minutes.

A single semi-occlusive application of test material to intact rabbit skin for 4 hours alicited slight to well-defined dermal irritation in all animals.

The mean scores for these reactions at approximately 24, 48 and 72 hours after administration, calculated separately for each animal are : 1.3, 2 and 1 for erythema, and 0.3,1.3 and 1 for oedema.

Based on these results, the test material is considered to be slightly skin irritating.