Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Constituent 1
Chemical structure
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:
There were no signs of systemic toxicity.


There were no signs of systemic toxicity.


All animals showed expected bodyweight gains over the study
period.
Body weight:
All animals showed expected gains in bodyweight 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.