4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

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

Remarks:

basic information given; scientifically acceptable

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

In accordance with the techniques specified in the Regulations for the Enforcement of the Federal Hazardous Substances Act (Code of Federal Regulatioris, Title 16, Part 1500).

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

EC Number:

223-496-2

EC Name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

Cas Number:

3923-79-3

Molecular formula:

C5H10N2O3

IUPAC Name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

Details on test material:

Name of the test substance used in the study report: Textile Resin NF-U

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rabbits were individually identified by means of numbered ear tags.
The rabbits were housed in individual stainless steel cages suspended above the droppings. Food, consisting of Purina Laboratory Chow, and water were available at all times. The animals were kept on a 12-hour light/12-hour dark cycle.
Weight range 2431 to 3000 gram.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The rabbits were acclimated to the laboratory for at least 10 days before being dosed. The dose was applied to the abdominal skin area from which the fur had been previously removed with electric clippers. The abdominal skin area of half of the rabbits in the group was abraded by making a series of longitudinal minor epidermal incisions placed two to three centimeters apart, using a hypodermic needle as a cutting tool. The abrasions were sufficiently deep to penetrate the epidermis but not to induce bleeding. The skin of the remaining rabbits in the group remained intact. An equal number of males and females were assigned to the intact skin and abraded skin sub-groups.
The undiluted sample was applied at a dosage level of 3.0 ml/kg of body weight. The sample was introduced into a sleeve of rubber dental damming which was wrapped around the trunk of the animal and secured with staples. An outer layer of gauze and tape was placed around the trunk of the animal. The rabbit was restrained for 24 hours in a Newmann harness.
At the end of the 24-hour exposure period the binder was removed and any unabsorbed sample remaining on the skin was removed by gentle sponging with a moistened towel.
Each rabbit was examined throughly for gross signs of systemic toxicity and dermal irritation.
All rabbits were maintained for 14 days following completion of the exposure period. Examinations for gross signs of systemic toxicity and dermal irritation were carried out at frequent intervals during this period. At the end of the 14-day observation period the rabbits were weighed, sacrificed by T-61 overdose, and a gross necropsy was performed on each animal.

Duration of exposure:

24 hours

Doses:

3.0 mL/kg

No. of animals per sex per dose:

10

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 mL/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 300 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

none

Clinical signs:

other: Upon removal of the binders from the animals, the exposed area and binder appeared dry with no sample apparent on any of the animals. This proved evidence of complete dermal absorption of the sample. Irritative effects noted during the study included eryt

Gross pathology:

Gross necropsies performed at the termination of the study revealed pitted kidneys in one animal. No other gross-pathological alterations or lesions were noted in any of the rabbits.

Any other information on results incl. tables

Body weight changes (dose level: 3.0 ml/kg):

Rabbit No.	Sex	Skin		Body weight
		Intact	Abraded	Start (gm)	Finish (gm)	Change (gm)
1	male	x		2691	2971	280
2	male		x	2964	3292	328
3	male	x		3000	3531	531
4	female		x	2998	3327	329
5	male	x		2940	3069	129
6	male		x	2995	3215	220
7	female	x		2999	3302	303
8	female		x	2599	2709	110
9	female	x		2431	3024	593
10	female		x	2775	3145	370