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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to GLP and is equivalent to a guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 5,5-dimethylhydantoin
- Physical state: Solid (white crystalline powder)
- Storage condition of test material: Room temperature in a locked cabinet

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries, Indianapolis. Indiana
- Age at study initiation: Young adult
- Weight at study initiation: Males: 151 - 159 g. Females: 131 - 146 g
- Housing: Individually housed in stainless steel cages
- Diet: ad libitum
- Acclimation period: 8 days


Administration / exposure

Route of administration:
oral: gavage
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for gross signs of systemic toxicity and mortality at frequent intervals during dosing and twice daily thereafter. All rats were weighed on day 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Mortality:
No mortalities occurred during the study
Clinical signs:
On the day of dosing two females were observed to be slightly to moderately lethargic and slight lacrimation was noted which subsided by day 1. The females were observed to be normal throughout the remainder of the study
Gross pathology:
No signs of systemic toxicity were observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The acute oral LD50 DMH was > 5000 mg/kg