Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 18 June to 03 July 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch No.: not specified
Purity: not specified

Test animals

Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: The rats were deprived of food but not water overnight prior to dosing.
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR Part 3.

IN-LIFE DATES: From: 18 June 1980 To: 03 July 1980

No additional data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Each animals was dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle. Deviations are considered not to effect the validity of the study result.
Doses:
1.0, 2.0, 4.0, 8.0 and 16.0 g/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed once daily, weighed on initial day and final day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross pathology.
Statistics:
None stated

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
No untoward symptoms were observed at the dosage levels of 1.0-8.0 g/kg. At 16.0 g/kg the animals were slightly dirty and ruffled after 18-24 hours. They appeared normal and clean after 48 hours.
Body weight:
Normal body weight gains were observed.
Gross pathology:
Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of Methylenebis (dibutyldithiocarbamate) to rats is greater than 16.0 g/kg.