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:
2000-09-18 to 200-10-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
22 March 1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
Directive 96/54/EEC
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
EC Number:
289-214-5
EC Name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
Cas Number:
86261-90-7
Molecular formula:
C9H14N2O3
IUPAC Name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: males: 150 g +/- 20 %; females: 150 g +/- 20 %
- Fasting period before study: over night
- Housing: animals were kept in Macrolon cages on Altromin saw fiber bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF), feeding at libitum
- Water: Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: Adequate acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 55 ± 10 %
- Air changes: 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.00 - 18.00

IN-LIFE DATES: From:2000-09-26 To: 2000-10-12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4000 mg of test item (50 % in water) were solved in 1 % conc. ad 10 mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no.: CMC, Sigma, Lot-No. 36H0738


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: The test substance was freshly mixed prior to application and stirred throughout dose administration to guarantee stability and homogenicity.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males/3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: Animals were observed for 14 days after dosing.
- Frequency of observations and weighing: The animals were weighed prior to first application and once a week thereafter.
- Necropsy of survivors performed: At the end of the observation period the animals were sacrificed by an overdosage of pentobarbital.
All animals were subjected to gross necropsy. All gross pathological changes were recorded.
- Other examinations performed: A careful clinical examination was made twice a day on the day of dosing and once a day thereafter.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No compound related mortality was observed.
Clinical signs:
No clinical signs of toxicity were observed throughout the observation period.
Body weight:
Throughout the 14-days observation period no weight loss was recorded. The weight gain for the male and female animals was within the expected range.
Gross pathology:
Necropsy revealed an acute injection of blood vessels in all animals in the abdominal region. This finding is due to euthanasia with an overdose of pentobarbital injected intraperitoneally.
No other macroscopic necropsy findings were recorded.
Other findings:
No other macroscopic necropsy findings were recorded.

Applicant's summary and conclusion

Categories Display