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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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Predates implementation of GLP and/or development of study guidelines, restrictions in reporting, acceptable with restrictions.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1964
Reference Type:
publication
Title:
Unnamed
Year:
1965

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Young adult Osborne-Mendel rats evenly divided by sex received the test substance. All doses were given by intubation. All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: methylenedioxybenzene

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult
- Fasting period prior to treatment: 18 hours
- Diet: food was replaced in cages as soon as animals received their respective doses.
- Water: access to water at all times


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on study design:
All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were seen, the animals were observed for only one week.
Statistics:
LD50's were computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
580 other: mg/kg
Based on:
test mat.
95% CL:
>= 487 - <= 690
Mortality:
Times of death 1 - 6 days
Clinical signs:
Depression and coma on high doses, rough fur, porphyrin-like deposit around eyes and nose
Other findings:
Slope function with 95% confidence limits: 1.4 (1.2-1.7)

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 reported for methylenedioxybenzene in rats was 580 mg/kg with 95% confidence limits of 487-690 mg/kg.
Executive summary:

In an acute oral toxicity study young adult Osborne-Mendel rats evenly divided by sex were fasted for approximately 18 hours prior to treatment. All doses were given by intubation. All animals were maintained under close observation for recording toxic signs and time of death. These observations were continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were seen, the animals were observed for only one week. Observed toxic signs were depression and coma on high doses, rough fur, porphyrin-like deposit around eyes and nose. Times of death 1 - 6 days. The LD50 reported for methylenedioxybenzene in rats was 580 mg/kg with 95% confidence limits of 487-690 mg/kg.