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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Near-guideline study, available as unpusblished report, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2-hydroxyethyl)imidazolidin-2-one
EC Number:
223-032-9
EC Name:
1-(2-hydroxyethyl)imidazolidin-2-one
Cas Number:
3699-54-5
Molecular formula:
C5H10N2O2
IUPAC Name:
1-(2-hydroxyethyl)imidazolidin-2-one
Details on test material:
- Name of test material: Hydroxyethylethylene urea
- CAS No.: 3699-54-5
- Appearance: white, solid, crystalline melt
- Purity: > 98%
- Impurities: urea < 1%, water < 1%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D7950 Biberach, FRG
- Weight at study initiation: animals of comparable weight (+- 20% of the mean weight)
- Fasting period before study: 16 hrs before administration
- Housing: stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG), 5 animals per cage
- Diet (ad libitum): Kliba-labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- vehicle: aqua dest
- justification for choice of vehicle: aqueous formulation corresponds to the physiological medium
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of signs and symptons several times on the day of administration. At least once each workday. Check for moribund and dead animals twice each workday and once on holidays
- Necropsy of survivors performed: yes
- Other examinations performed: body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality.
Clinical signs:
No abnormalities.
Body weight:
No effects.
Gross pathology:
No pathologic findings noted.

Applicant's summary and conclusion

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