Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Brief report of acute toxicity screening test: limited experimental detail and no test laboratory information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962
Report date:
1962

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Single dose toxicity screen using 1 rabbit and 3 rats.
GLP compliance:
no
Remarks:
Pre-GLP study
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
EC Number:
254-372-6
EC Name:
N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
Cas Number:
39236-46-9
Molecular formula:
C11H16N8O8
IUPAC Name:
N',N'''-methylenebis{1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea}

Test animals

Species:
other: Rabbit and rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
1 male rabbit, 3 female rats

Administration / exposure

Route of administration:
other: Rabbit injected intravenously, rats injected intraperitoneally
Vehicle:
water
Details on exposure:
Aquepus 50% solution of test substance injected.
Doses:
Rabbit: 2000 mg/kg.
Rats: 1000, 2000 and 4000 mg/kg
No. of animals per sex per dose:
1
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Rabbit: transient pain reaction and raised body temperature, recovered one day after dosing.
Sex:
female
Dose descriptor:
other: lethal dose
Effect level:
4 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Rat: no death at 1000 or 2000 mg/kg but animal dosed at 4000 mg/kg died within 21h of dosing.
Mortality:
Rabbit: no death in single animal dosed at 2000 mg/kg.
Rat: the single animal dosd at 4000 mg/kg died within 21h.
Clinical signs:
Ataxia, lethargy, abnormal posture seen in all 3 test rats.

Applicant's summary and conclusion

Conclusions:
Inravenous injection of test substance at 200 mg/kg was not lethal to a single test rabbit. One rat injected intraperitoneally at 4000 mg/kg died.