1-(2-hydroxyethyl)imidazolidin-2-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-hydroxyethyl)imidazolidin-2-one

EC Number:

223-032-9

EC Name:

1-(2-hydroxyethyl)imidazolidin-2-one

Cas Number:

3699-54-5

Molecular formula:

C5H10N2O2

IUPAC Name:

1-(2-hydroxyethyl)imidazolidin-2-one

Details on test material:

- Name of test material: HEEU
- Physical state: clear liquid containing 75% active ingredient
- Composition of test material, percentage of components: 1-(2-hydroxyethyl)imidazolidin-2-one: 75% Wt; water: 25% Wt.
- Lot/batch No.: Lot No. DLT 33:99
- Sample No.: 00-098

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: males were approximately 8 weeks old and the females were approximately 9 weeks old
- Weight at study initiation: from 251 to 262 g for males and from 208 to 224 g for females
- Fasting period before study: overnight
- Housing: individually housed in suspended stainless steel cages (18x34x20 cm) with wire mesh fronts and bottoms
- Diet (ad libitum): PMI Certified Rodent Diet 5002(C) (Purina Mills Inc., Richmond, IN)
- Water (ad libitum): via automatic watering, purified by reverse osmosis
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 23°C. During the study, the average daily temperature ranged from 21 to 22°C
- Humidity (%): range of 30-70%. During the study, the average daily relative humidity ranged from 51 to 65%
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: between the flank and shoulders, shaved intact skin
- % coverage: 10% body surface area
- Type of wrap if used: polyethylene sheet covered with Elastoplast® (Beiersdorf, Inc., Norwalk, CT) and PEG®(Becton-Dickinson Co., Franklin Lakes, NJ) elastic bandages and secured in place with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with paper towels saturated with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration: 100% HEEU containing 75% active ingredient
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw (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:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations 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.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were reported.

Clinical signs:

other: No clinical signs were reported.

Gross pathology:

Necropsy revealed no gross changes.

Other findings:

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 occluded testing methodology and by the use of collars.
No skin irritation effects were observed.