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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 17 June to 01 July 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Section 1500.40-Federal Hazardous Substances Act Regulations-16 CFR-P. 123
Deviations:
yes
Remarks:
One group of six albino rabbits was employed in this study (3 males and 3 females). Deviations are considered not to effect the validity of the study result.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
One group of six albino rabbits was employed in this study (3 males and 3 females). Deviations are considered not to effect the validity of the study result.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

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:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 2.0 and 3.0 kg
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR Part 3.

IN-LIFE DATES: From: 17 June 1980 To: 01 July 1980

No additional data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- Type of wrap if used: The treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg

No additional data
Duration of exposure:
24 hours
Doses:
2.0 g/kg
No. of animals per sex per dose:
3 males and 3 females
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/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
other: There were no unusual behavioral signs noted.
Gross pathology:
Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of Methylenebis (dibutyldithiocarbamate) to rabbits is greater than 2.0 g/kg.