2-(2-oxoimidazolidin-1-yl)ethyl methacrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-08-22 to 2001-09-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

92/69/EEC

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan 59 NohSan Notification No. 4200, Acute Dermal Toxicity Study

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-oxoimidazolidin-1-yl)ethyl methacrylate

EC Number:

289-214-5

EC Name:

2-(2-oxoimidazolidin-1-yl)ethyl methacrylate

Cas Number:

86261-90-7

Molecular formula:

C9H14N2O3

IUPAC Name:

2-(2-oxoimidazolidin-1-yl)ethyl methacrylate

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

other: Crl CD BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC.
- Age at study initiation: Females were approximately 9 weeks old and males were 8 weeks old.
- Weight at study initiation: The body weights ranged from 258 to 275 g for males and from 203 to 241 for females.
- Fasting period before study:
- Housing: The animals were individually housed in suspended stainless steel cages (18x34~20c m) with wire mesh fronts and bottoms. Cages were suspended above absorbent-paper pan liners which were changed 3 times a week.
- Diet: Throughout the test period, all rats had free access to PMI Certified Rodent Diet 5002(C) (Purina Mills Inc., Richmond, IN).
- Water: Throughout the test period, all rats had free access to water (via automatic watering) purified by reverse osmosis.
- Acclimation period: approximately one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 46-58
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: entire trunk between flank and shoulders; intact skin
- % coverage: approx. 6*6 cm (10% of the body surface area (target))
- Type of wrap if used: Polyethylene sheet covered with Elastoplast elastic bandages and secured in place with adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing: After the 24-hr exposure, the application sites were wiped with paper towels saturated with tap water and blotted dry with paper towels.

Duration of exposure:

24 h

Doses:

5000 mg/kg bw. The dose was calculated on an "as is" basis; no adjustment was made for percent active ingredient.

No. of animals per sex per dose:

5

Control animals:

other: Historical data were used for weight controls.

Details on study design:

All animals were observed for signs of ill health, or reaction to treatment at approximately 1, 2 and 4 hrs after dosing and once daily thereafter for 14 days. Body weights were recorded on day 0 (prior to dosing) and on days 7 and 14. Surviving rats were euthanized on day 14 and necropsied. Necropsy consisted of a gross examination of organs in situ.

Statistics:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

- Time of death: No mortality was observed.
- Number of deaths at each dose: No mortality was observed.

Clinical signs:

other: Scant feces was observed in 2 females on a single day during the observation period. Periodically during the study, the fur surrounding the eyes and muzzle of several animals was observed to be red stained; these effects were judged to be caused by the oc

Gross pathology:

No gross changes.

Other findings:

LOCAL FINDINGS
Signs of skin irritation including edema, erythema and desiccation was observed beginning day 1 of the observation period and continuing through day 11.