Registration Dossier

Administrative data

Description of key information

Oral:
In this study, the acute oral LD50 is greater than 16.0 g/kg (Biosearch, Inc., 1980)
Inhalation:
The vapour pressure of Methylenebis (dibutyldithiocarbamate) is <1.3E-08 Pa at 20 ºC and there is no predicated inhalation exposure, therefore, this endpoint is waived.
Dermal:
In this study, the acute dermal LD50 is greater than 2.0 g/kg (Biosearch, Inc., 1980).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
16 000 mg/kg bw
Quality of whole database:
2 (reliable with restrictions)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
2 (reliable with restrictions)

Additional information

Oral:

According to OECD Guideline 401 (not conducted under GLP) male rats were exposed orally via gavage to Methylenebis (dibutyldithiocarbamate) (Biosearch, Inc., 1980). In this study, the acute oral LD50 is greater than 16.0 g/kg.

Inhalation:

According to Column 2 of Annex VIII of the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 1902/2006 regulation, inhalation study does not need to be conducted if exposure of humans via inhalation is likely taking into account the vapour pressure (<0.01 Pa at 20ºC is considered the cut off) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapour pressure of of Methylenebis (dibutyldithiocarbamate) is <1.3E-08 Pa at 20 ºC and there is no predicated inhalation exposure, therefore, this endpoint is waived.

Dermal:

In a study conducted according to equivalent or similar to test guidelineSection 1500.40-Federal Hazardous Substances Act Regulations-16 CFR-P(not conducted under GLP), male and female rabbits were exposed dermally to Methylenebis (dibutyldithiocarbamate) (Biosearch, Inc., 1980). In this study, the acute dermal LD50 is greater than 2.0 g/kg.


Justification for selection of acute toxicity – oral endpoint
The study was conducted in accordance with recognised scientific guidelines appropriate for the date the study was conducted (OECD 401). Limited deviations were observed in the study, however these were considered not to effect the validity of the study result. While the study was not conducted in accordance with GLP, due to the age of the study (1980) and the location of the testing laboratory (USA) it is considered that as the study was conducted at a reputable contract reasearch laboratory, this should not effect the reliability of the study result.

Justification for selection of acute toxicity – inhalation endpoint
According to Column 2 of Annex VIII of the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 1902/2006 regulation, inhalation study does not need to be conducted if exposure of humans via inhalation is likely taking into account the vapour pressure (<0.01 Pa at 20ºC is considered the cut off) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapour pressure of of Methylenebis (dibutyldithiocarbamate) is <1.3E-08 Pa at 20 ºC and there is no predicated inhalation exposure, therefore, this endpoint is waived.

Justification for selection of acute toxicity – dermal endpoint
The study was conducted in accordance with recognised scientific guidelines appropriate for the date the study was conducted (equivalent or similar to Section 1500.40-Federal Hazardous Substances Act Regulations-16 CFR-P. 123 and in accordance with OECD 402). Limited deviations were observed in the study, however these were considered not to affect the validity of the study result. While the study was not conducted in accordance with GLP, due to the age of the study (1980) and the location of the testing laboratory (USA) it is considered that as the study was conducted at a reputable contract research laboratory, this should not effect the reliability of the study result.

Justification for classification or non-classification

Acute toxicity - oral:

The acute oral LD50 of Methylene bis (dibutyldithiocarbamate) is 16.0 g/kg in rats, therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1 Methylene bis (dibutyldithiocarbamate) is not classifed for Acute Oral Toxicity.

Acute toxicity - Dermal:

The acute dermal LD50 of Methylene bis (dibutyldithiocarbamate) is > 2.0 g/kg in rabbits, therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1, Methylene bis (dibutyldithiocarbamate) is not classifed for acute dermal toxicity.