sodium 4,4-dimethyl-2,5-dioxoimidazolidin-1-ide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 14- July 5, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed in compliance with GLP standards and in accordance with the Guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2004/73/EC

GLP compliance:

yes (incl. QA statement)

Remarks:

see data source

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

476-160-4

EC Name:

-

Cas Number:

54807-34-0

Molecular formula:

C5H7N2NaO2

IUPAC Name:

sodium 4,4-dimethyl-2,5-dioxoimidazolidin-1-ide

Details on test material:

Identification: NaDMH
Description: white powder
Storage conditions: RT, in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Female Sprague-Dawley CD (Crl: CD(R) IGS BR) strain rats were supplied by the testing lab. The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continous light (06:00 to 18:00) and twelve hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level.
The test material was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity. There were no signs of systemic toxicity. All animals showed expected bodyweight gains over the study period.

Gross pathology:

There were no abnormalities noted at necropsy.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg
bodyweight.

Executive summary:

The acute oral median lethal dose (LD50) of NaDMH in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight.