5,5-Dimethylimidazolidine-2,4-dione, reaction products with oxirane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19th November 1986 to 3rd December 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione

EC Number:

701-388-0

Cas Number:

26850-24-8

IUPAC Name:

1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione

Test material form:

other: pale yellow solid block

Details on test material:

- Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: mist

Type of inhalation exposure:

whole body

Vehicle:

other: water

Mass median aerodynamic diameter (MMAD):

3.4 µm

Geometric standard deviation (GSD):

2

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

240 min

Concentrations:

5 mg/L

No. of animals per sex per dose:

Five/sex/dose

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.5 mg/L air

Based on:

test mat.

Exp. duration:

240 min

Mortality:

None.

Clinical signs:

other: None.

Body weight:

No change.

Gross pathology:

None.

Other findings:

Chromodacryarrhoea was observed in all animals by the end of the exposure period indicating that the test material could be an ocular irritant. The effect was found to be reversible.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A 4-hour inhalation LC50 of > 5.5mg/L is estimated for the test material based on the absence of mortality or evidence of gross systemic toxicity in SD rats following inhalation exposure.

Executive summary:

In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by inhalation exposure at a dose level of 5 mg/L (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LC50 is 5 mg/L.