3,6,9-trioxaundecamethylene dimethacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-07-01 to 1997-07-04

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

limited documentation of test data and substance purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981) and EEC guideline 84/449/EWG, B.4

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-ethylenedioxydiethyl dimethacrylate

EC Number:

203-652-6

EC Name:

2,2'-ethylenedioxydiethyl dimethacrylate

Cas Number:

109-16-0

Molecular formula:

C14H22O6

IUPAC Name:

ethane-1,2-diylbis(oxyethane-2,1-diyl) bis(2-methylacrylate)

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Three healthy adult rabbits of the New Zealand Whte strain were obtained from Harlan Interfauna
(UK) Ltd., Huntingdon, Cambridgeshire, England.
They were in the weight range of 2.4 to 2.6 kg and approximately 10 to 11 weeks of age, prior to
treatment (Day 1). All rabbits were acclimatised to the experimental environrnent.
The rabbits were selected without conscious bias for the study. They were housed individually in meta1
cages with perforated floors in Building R 1 4 Room 5.
A standard laboratory diet SDS Stanrab (P) SQC Rabbit Diet and drinkmg water were provided ad
libitum.
The batch of diet used for the study was analysed for nutrients, contarninants and micro-organisms.
Results of routine physical and chemical examination of drinking water as conducted by the supplier,
are made available to Huntingdon Life Sciences Ltd as quarterly sumrnaries.
Amal room temperature was maintained at 16 to 20°C and relative hurnidity at 52 - 72%. These
environmental pararneters were recorded daily. Air exchange was maintained at approximately 19 air
changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial
light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This
nurnber was unique within the Huntingdon Life Sciences Acute Toxicology Departrnent throughout the
duration of the study. Each cage was identified by a coloured labe1 displayng the study schedule
number, animal number and initials of the Study Director and Home Office licensee.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin areas of the test animals serve as the control (clipped).

Amount / concentration applied:

0.5 mL undiluted test substance

Duration of treatment / exposure:

72 hours

Observation period:

Examination of the treated skin was made on Day 1 (ie 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

Details on study design:

TREATMENT PROCEDURE
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 skm approximately 100 mm x100 mm.
Approximately 0.5 ml of the test substance was applied under a 25 mrn x 25 mrn 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 retumed to their cages immediately
after treatment.
At the end of the exposure penod, 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.

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

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


SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

not observed

Any other information on results incl. tables

Overall primary irritation score (PDII): 0.0 of 8 scores FDA (Draize), 1959,  re-evaluated according to OECD 404

Reevaluation of the test results according to OECD404/GHS: only records for the shaved skin were considered  Erythema/ 24h     Erythema/72h  Oedema/24h  Oedema/72h  animal 1  0  0  0  0  animal 2  0 0  0  0  animal 3  0  0  0  0  average (single scores: animal 1 -3)  0.00  0.00  0.00  0.00  Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores  0.00  Primary irritation index II =  Mean oedema score (Oedema; 24h, 72h);   out of 4 scores  0.00    Overall average PDII out of 8 scores; For evaluation according to GHS classification system:  0.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not skin irritating

Conclusions:

The results demonstrate that TREGDMA is not a dermal irritant

Executive summary:

In a primary dermal irritation study according to OECD TG 404, New Zealand white rabbits were dermally exposed to 0.5 mL Ethylene glycol dimethacrylate (TREGDMA; CAS 109-16-0) for 72 hours. The mean erythema score was determined to be 0.00 out of 4 and, accordingly, the mean edema score 0.00 out of 4. Systemic toxic effects could not be detected as well.The results demonstrate that TREGDMA is not a dermal irritant.

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