Registration Dossier

Administrative data

Description of key information

The collected experimental data suggest that the substance does not meet the criteria for acute toxicity classification either for oral or dermal route of exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
GLP compliance:
not specified
Specific details on test material used for the study:
Identity: 5,5-Dimethylhydantoin (CAS RN 77-71-4)
Purity: No information provided

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
8 430 mg/kg bw
Clinical signs:
The following linical signs were reported:

LUNGS, THORAX, OR RESPIRATION: dyspnea

BEHAVIORAL: withdrawal, somnolence (general depressed activity)
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 for 5,5-Dimethylhydantoin was determined to be 8430 mg/kg in guinea pig.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
GLP compliance:
not specified
Specific details on test material used for the study:
Identity: 5,5-Dimethylhydantoin (CAS RN 77-71-4)
Purity: No information provided
Species:
rabbit
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
12 660 mg/kg bw
Clinical signs:
The following effect were reported:
LUNGS, THORAX, OR RESPIRATION: dyspnea
BEHAVIORAL: somnolence (general depresses activity), regidity
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 for 5,5-Dimethylhydantoin was determined to be 12660 mg/kg in rabbit.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
GLP compliance:
not specified
Specific details on test material used for the study:
Identity: 5,5-Dimethylhydantoin (CAS RN 77-71-4)
Purity: No information provided
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 7 800 mg/kg bw
Clinical signs:
The following effect were reported:
LUNGS, THORAX, OR RESPIRATION: dyspnea
BEHAVIORAL: withdrawal, somnolence (general depressed activity)
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 for 5,5-Dimethylhydantoin was determined to be 7800 mg/kg in rat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
GLP compliance:
not specified
Specific details on test material used for the study:
Identity: 5,5-Dimethylhydantoin (CAS RN 77-71-4)
Purity: No information provided
Species:
mouse
Strain:
New Zealand White
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
The route of exposure specified is the subcutaneous one. As a conservative assumption the subcutaneous route was use for the evaluation of the acute dermal toxicity of the substance.
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Interpretation of results:
GHS criteria not met
Conclusions:
The route of exposure specified is the subcutaneous one. As a conservative assumption, the subcutaneous route was used for the evaluation of the acute dermal toxicity of the substance.
The acute dermal LD50 for 5,5-Dimethylhydantoin was determined to be 2800 mg/kg in mouse.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 800 mg/kg bw

Additional information

Justification for classification or non-classification

The substance does not meet the criteria for acute toxicity classification for either oral or dermal route of exposure.