Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-September 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The objective was to investigate the degree of irritation produced to the abraded and intact skin of 6 albino rabbits following 24 hours occluded contact with the test material. The procedure used is that described in the US Federal Register 1973, Vol.38, No.187, Section 1500:41.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine

EC Number:

500-425-6

EC Name:

Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine

Cas Number:

159034-91-0

Molecular formula:

Not available for this UVCB

IUPAC Name:

Reaction product of poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[(1-oxo-2-propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) and N-ethylethanamine

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS = Healthy females
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: in grid bottomed galvanised metal cages.
- Diet (e.g. ad libitum): 90-95g of a commercially available pelleted rabbit diet were provided for each animal at a similar time each day.
- Water (e.g. ad libitum): An automatic watering system provided a constant summply of drinking water to the cages.
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no details, but air-conditionned-room
- Photoperiod (hrs dark / hrs light): 10h/14h

Test system

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

No preparation of the supplied material was necessary.
0.5 ml of the test material was applied to each of two 2.5 cm square surgical lint pads attached to "sleek" plastic adhesive wrapping. The lint suares were then placed in contact with the animal's skin, one lint square in contact with abraded skin and one lint square with intact skin, bilateral to the midline, and secure in position by the attached "Sleek" adhesive tape. The entire trunk of the animal was then encircled with a length of elastic adhesive bandage 7.5 cm wide.

Duration of treatment / exposure:

24h

Observation period:

The reaction sites were assessed at 1 hour and at 48 hours after patch removal.

Number of animals:

6

Details on study design:

At least one hour before dosing the rabbits were placed in restraining stocks and the dorsal surface of the rabbits closely clipped ove an area consisting of approximately 10% of the total surface area, using an Oster model A.2 clipper with Angra blade.
The left flank was then lightly abraded with the point of 25 x 0.6 mm sterila disposable hypodermic needle. The abrasions were sufficiently deep to damage the stratum corneum but not to penetrate the dermis. the skin of the right flank remainded intact.

After a contact period of 24 hours the adhesive tapes and lint patches were removed from the animals. One hour was then allowed to permit irritation from the adhesive tapes to subsade then the reaction sites were assessed using the scoring system of Draize.

The values obtained for erythema at both abraded and intact sites at the 24 and 72 hour readings were summed and the total divided by six, the number of rabbits, to give an average score for erythema. The values obtained for oedema were treated in a similar manner to give an average score for aedema. A primary irritation score was calculated by adding the total value obtained for erythema to tje total of value obsained for oedema dividing by six to give an average of the total score. This average was then divided by four to give a value referred to as the primary irritation score.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

1.08

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Intact skin / Individual scores = 2 - 1 - 0.5 - 0.5 - 0.5 - 2

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Intact skin / individual scores = 1 - 0 - 0 - 0 - 0 - 2

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Abraded skin / Individual scores = 2 - 1 - 1 - 0.5 - 1.5 - 2

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Abraded skin / Individual scores = 1 - 0.5 - 0 - 0 - 0.5 - 2

Irritant / corrosive response data:

The average scores produced by the group of 6 rabbits were 4.8 for erythema and 2.3 for oedema, giving a primary irritation score of 1.8.
No data on reversibility of effects are showed.

Other effects:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not skin irritating

Conclusions:

According to this study, Diethylamine modified ethoxylated trimethylolpropane triacrylate is considered as slightly irritant but it is not classified as skin irritant according to CLP criteria.

Executive summary:

The objective of this study was to investigate the degree of irritation produced to the abraded and intact skin of 6 albino rabbits following 24 hours occluded contact with Diethylamine modified ethoxylated trimethylolpropane triacrylate.

Erythema and/or oedema were observed in all animals exposed to the substance (intact and abraded skin). However the effect are not severe, each score is equal or smaller than 2 (out of 4).

Diethylamine modified ethoxylated trimethylolpropane triacrylate is considered as slightly irritant but it is not classified as irritant according to CLP criteria.