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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predates GLP and test guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
Test substance applied dermally (occlusive dressing) for 24 hours, dressing removed (site not washed) and rabbits observed for up to 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
5,5-dimethylhydantoin
EC Number:
201-051-3
EC Name:
5,5-dimethylhydantoin
Cas Number:
77-71-4
IUPAC Name:
5,5-dimethylimidazolidine-2,4-dione
Constituent 2
Reference substance name:
Dimethylhydantoin
IUPAC Name:
Dimethylhydantoin
Details on test material:
- Name of test material (as cited in study report): Dantoin DMH
- Name of test material (as cited in study report): 5,5-Dimethylhydantoin (DMH)
-Physical state: white crystals

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test animals
Source: Marland Breeding Farms, Inc.
Weight at study initiation: 2.0-3.5 kgs
Housing: individual
Diet: ad libitum
Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: saline
Details on dermal exposure:
TEST SITE
- % coverage: 10%

TEST MATERIAL
- Amount applied: Each dose was weighed out and 20-25 mL of normal saline was added to moisten the material. A dose level of 20000 mg/kg was applied.


Duration of exposure:
14 days
Doses:
20000 mg/kg
No. of animals per sex per dose:
3/sex/group
Control animals:
no
Details on study design:
Two females and one male received the substance applied to abraded skin, two males and one female received the substance on intact skin.

Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred in the study
Clinical signs:
other: Fecal staining/soft stool, nasal discharge, ocular discharge, collar removed by animal, piloerection, motor activity increase and aggressive behaviour.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
LD50 was estimated > 20000 mg/kg bw.
Executive summary:

This study has been performed on DMH (Dimethyl Hydantoin) and has been used for read-across purposes.

LD50 was estimated > 20000 mg/kg bw.