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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: Scientifically valid study, comparable to guideline, but not according to current standards or GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959
Reference Type:
secondary source
Title:
Unnamed
Year:
2003
Report Date:
2003
Reference Type:
publication
Title:
1,3-Dimethylurea (CAS: 96-31-1), SIDS Initial assessment report for SIAM 17
Author:
OECD SIDS
Year:
2009
Bibliographic source:
Unep publications
Report Date:
2003

Materials and methods

Principles of method if other than guideline:
BASF test: In principle, the methods described in OECD Guideline 401 were used.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,3-Dimethylurea, N,N'-Dimethylurea
- Physical state: cristalline
- Analytical purity: technical grade

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: breeder
- Age at study initiation: Young adult
- Weight at study initiation: Average weight at beginning of the test: 96 - 174 g
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The doses were applied as 1 % or 10% preparations of the test substance in aqua dest.

MAXIMUM DOSE VOLUME APPLIED: no data

DOSAGE PREPARATION (if unusual):
- The concentrations of these preparations were usually adjusted to achieve comparable volumes (e.g. 10 ml) per kg body weight.

Doses:
20; 79; 316; 1260 mg/kg (1 animal per dose); 3160; 5010; 6310; 7940; 10000 mg/kg (5 animals per dose)
No. of animals per sex per dose:
5 rats per dose group, except for the four lowest dose levels (1 rat/dose).
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Body weight was determined before the beginning of the study for dose calculation.
Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: no, only of the died animal.
Statistics:
On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 000 mg/kg bw
Based on:
test mat.
Mortality:
Results are given as dead animals/total number of animals at this dose at 24 h, 48 h and 7 days after dosing:
20 mg/kg bw: 0/1, 0/1, 0/1
79 mg/kg bw: 0/1, 0/1, 0/1
316 mg/kg bw: 0/1, 0/1, 0/1
1260 mg/kg bw: 0/1, 0/1, 0/1
3160 mg/kg bw: 0/5, 0/5, 0/5
5010 mg/kg bw: 0/5, 0/5, 4/5
6310 mg/kg bw: 0/5, 4/5, 5/5
7940 mg/kg bw: 1/5, 5/5, 5/5
10000 mg/kg bw: 5/5, 5/5, 5/5
Clinical signs:
unspecific; apathy and narcotic like state at doses near to or exceeding the LD50. None of the animals had blood in the urine.

SYMPTOMS PER DOSE GROUP:
20-3160 mg/kg bw: no symptoms
5010 mg/kg bw: piloerection, vocalisation during urination
6310-7940 mg/kg bw: piloerection, narcotic-like state
10000 mg/kg bw: partly lateral position, staggering-unsteady gait, apathy, piloerection, narcotic-like state
Body weight:
No data
Gross pathology:
In 2 animals stomach filled with liquid and dilated, all other animals without findings in the inner organs . Necropsy was performed by a pathologist.
Other findings:
No other fndings

Applicant's summary and conclusion