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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Version / remarks:
No reference to a guideline provided in the publication.
Principles of method if other than guideline:
Non-pregnant female CD-1 mice were intraperitonally injected hydantoin suspended in methylcellulose on 3 consecutive days. Mortality was recorded for up to 14 days following the final injection.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydantoin
EC Number:
207-313-3
EC Name:
Hydantoin
Cas Number:
461-72-3
Molecular formula:
C3H4N2O2
IUPAC Name:
hydantoin
Test material form:
not specified
Specific details on test material used for the study:
Material was greater than 98% pure, as determined by GLC, TLC, and NMR techniques.

Test animals

Species:
mouse
Strain:
CD-1
Sex:
female
Details on test animals or test system and environmental conditions:
Adult female non-pregnant CD-1 mice (Charles River Laboratories, Wilmington, Mass.)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
methylcellulose
Remarks:
suspension, 0.5%, w/w, 1 mL/100 g body wt
Details on exposure:
Single daily ip injections on 3 consecutive days
Doses:
Not specified
No. of animals per sex per dose:
Not specified
Control animals:
not specified
Details on study design:
Mortality was recorded for up to 14 days following the final injection.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
53.7 other: mmol/kg/day
Based on:
test mat.
95% CL:
47.6 - 62.1
Sex:
female
Dose descriptor:
LD50
Effect level:
5 374 mg/kg bw
Based on:
test mat.
95% CL:
> 4 764 - <= 6 215
Remarks on result:
other: calculated based on the mmol/kg/day values
Mortality:
Yes, but no details stated
Clinical signs:
Not specified
Body weight:
Not specified
Gross pathology:
Not specified

Applicant's summary and conclusion

Conclusions:
Female non-pregnant CD-1 mice were administered hydantoin intraperitoneally daily on 3 consecutive days. The resulting LD50 was calculated to be 5374 mg/kg bw/day (4764 - 6215 mg/kg bw/day).