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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-methylene bis(dibutyldithiocarbamate)
EC Number:
233-593-1
EC Name:
4,4'-methylene bis(dibutyldithiocarbamate)
Cas Number:
10254-57-6
Molecular formula:
C19H38N2S4
IUPAC Name:
N,N-dibutyl({[(dibutylcarbamothioyl)sulfanyl]methyl}sulfanyl)carbothioamide
Constituent 2
Reference substance name:
4,4'-Methylene(dibutyldithiocarbamate)
IUPAC Name:
4,4'-Methylene(dibutyldithiocarbamate)
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 or test system 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:
other: 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.
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.