2,2'-ethylenedioxydiethyl dimethacrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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:

publication

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

subacute study according to EPA Dermal Bioassay Workshops (April 28-29, 1987 and May 18-19, 1988), 14 d dose range finder

GLP compliance:

yes

Test type:

other: 14 d dose-range finding study

Limit test:

no

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:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): triethylene glycol dimethacrylate

Test animals

Species:

mouse

Strain:

other: C3H/HeNHsd

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague-Dawley (Indianapolis, IN)
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2-3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-77
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

open

Vehicle:

acetone

Details on dermal exposure:

TEST SITE
applied to the clipped interscapular region of the back
- Type of wrap if used: no wrap
- Time intervals for shavings or clipplings: during the week prior to the first dose and as needed during the dosing period, the fur was clipped from the dorsal area of the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): 25, 50, 100%

USE OF RESTRAINERS FOR PREVENTING INGESTION: no

Duration of exposure:

14 d

Doses:

50 µl of 25, 50, 100% corresponding to approximately 500, 1000 and 2000 mg/kg bw/d

(density = 1.092 g/cm³; body weight assumed 25 g; purity 91%; resulting in 500 mg/kg bw/d for 25% dose group,1000 mg/kg bw/d for 50% dose group and 2000 mg/kg bw/d for 100% dose group)

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: dose was applied daily for 14 days

Mortality:

no mortality occurred in all dose groups

Clinical signs:

other: no significant clinical observations

Gross pathology:

No necropsy findings on internal organs

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The dermal LD50 of TREGDMA is greater than 2000 mg/kg bw even when this dose is not applied once, but daily for 14 days.

Executive summary:

In a dose-range-finding study for a repeated-dose dermal toxicity study, TREGDMA (95% a.i.) was applied to the shaved skin of 5 male C3H/HeNHsd mice/dose at dose levels of 0, 25, 50 and 100% (applied in 50 µL) corresponding to approx. 500, 1000 and 2000 mg/kg bw/d for 14 days.

No mortality, no significant clinical signs, and no necropsy findings on internal organs were observed in all dose groups.

Desquamation and exfoliationwas the only skin finding noted during the study and at necropsy in the 50 and 100% TREGDMA treated groups. Microscopic changes in the treated skin primarily consisted of dermatitis, intracorneal pustule formation, acanthosis, and hyperkeratosis. Epidermal necrosis or ulceration was not evident in the treated mice. 

The dermal LD50 in this study was greater than 2000 mg/kg bw even when this dose is not applied once, but daily for 14 days.