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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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
Reliability:
2 (reliable with restrictions)

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 3 animals used per test group
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5,5-dimethylhydantoin
EC Number:
201-051-3
EC Name:
5,5-dimethylhydantoin
Cas Number:
77-71-4
Molecular formula:
C5H8N2O2
IUPAC Name:
5,5-dimethylimidazolidine-2,4-dione

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

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

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ~20-25 ml


Duration of exposure:
24 hours
Doses:
20 000 mg/kg
No. of animals per sex per dose:
3/sex/group
Control animals:
no
Details on study design:
2 females and 1 male received the substance applied to abraded skin, 2 males and 1 female received the substance on intact skin.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: In-life signs observed within 24 hours of dosing included motor activity decrease and ataxia. Other signs included fecal staining/soft stool, nasal discharge, ocular discharge, collar removed by animal, piloerection, motor activity increase and aggressive
Gross pathology:
No effects specified

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 Dantoin DMH >20000mg/kg.