GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 683-18-1
Chemical Name Dibutyltin dichloride
Substance ID H28-A-023, C-068A
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- -  There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- -  Solid (GHS definition).
3 Aerosols Not applicable
-
-
- -  Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- -  Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- -  Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- -  Solid (GHS definition).
7 Flammable solids Classification not possible
-
-
- -  It is combustible (HSDB (Access on June 2016)), but the classification is not possible due to no data.
8 Self-reactive substances and mixtures Not applicable
-
-
- -  There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- -  Solid (GHS definition).
10 Pyrophoric solids Classification not possible
-
-
- -  No data available.
11 Self-heating substances and mixtures Classification not possible
-
-
- -  Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- -  It contains a metalloid (Sn), but it is estimated that it does not react vigorously with water because water solubility data of 92 mg/L was obtained (SRC (Access on June 2016)).
13 Oxidizing liquids Not applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Not applicable
-
-
- -  It contains chlorine, which is the anion of organotin salt and does not contribute to oxidation.
15 Organic peroxides Not applicable
-
-
- -  Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- -  It is a solid substance with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
 This substance was classified in Category 3 based on 3 reports of LD50 value of 58.28 mg/kg (SIDS (2009)), 100 mg/kg (PIM 586 (1994), HSDB (Access on June 2016)) and 219 mg/kg (SIDS (2009), CICAD 73 (2006)) for rats.
1 Acute toxicity (Dermal) Classification not possible
-
-
- -  Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Category 2


Danger
H330 P304+P340
P403+P233
P260
P271
P284
P310
P320
P405
P501
 Based on the report of LC50 value (4 hours) of 59 mg/m3 (SIDS (2009), CICAD 73 (2006)) for rats, this substance was classified in Category 2.
2 Skin corrosion/irritation Category 1


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
 It is reported that this substance was highly irritating in a skin irritation test using rabbits (SIDS (2009)) and also corrosive in a dermal exposure test using rats (CICAD 73 (2006)). Irritation is also reported for humans (PIM 586 (1994), Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010)), therefore, this substance was classified in Category 1.
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
 Severe irritation was observed in an eye irritation test using rabbits (SIDS(2009)). Therefore, this substance was classified in Category 1.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
 As for in vivo, micronucleus tests using bone marrow cells of rats and mice were positive and negative (CICAD 73 (2006), Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)). As for in vitro, the results of bacterial reverse mutation tests and in vitro mammalian cell gene mutation tests were positive or negative, and the chromosomal aberration test was positive (ATSDR (2005), CICAD 73 (2006), Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)). Therefore, the substance was classified in Category 2 in accordance with the GHS classification guidance for the Japanese Government.
6 Carcinogenicity Classification not possible
-
-
- -  Since organotin compounds are classified in A4 by ACGIH (ACGIH (7th, 2001)), this substance was classified as "Classification not possible."
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
 As a result of dosing rats by feeding for 28 days including 2 weeks premating and mating for males and additionally through pregnancy and delivery and until the end of lactation for females, lower delivery index, decrease in the number of births, decrease in survival index and decrease in body weight gain in offsprings were observed at a dose where decrease in body weight gain (males and females), decrease in thymus weights and lymphocyte depletion (females), and an increase in ovarian cysts were observed in parent animals (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)).
 In addition, in multiple developmental toxicity studies using pregnant rats dosed in the organogenesis stage, an increase in post-implantation loss, a decrease in fetus body weight, and increases in the occurrence of various malformations such as external malformations (exencephalia, cleft of the mandible, cleft palate, ankyloglossia, umbilical hernia, etc.), skeletal malformations (fusion or absence of cervical or thoracic vertebral arches/bodies, fusion or absence of ribs, etc.), anophthalmia and microphthalmia etc. were observed in the fetus at less than or equal to the dose which suppressed body weight gain, a decrease in food consumption and some cases of death were observed in maternal animals (Environmental Document Risk Assessment Vol. 8 (Ministry of the Environment, 2010), SIDS (2009), CICAD 73 (2006)).
 Therefore, this substance was classified in Category 1B.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory organs)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
 No single exposure data in humans are available.
 As for experimental animals, it is described that in a 1-hour single inhalation exposure test using rats, bloody nasal discharge, and respiratory distress with gasping and wheezing were observed at doses of 0.64 mg/L (converted guidance value: 0.16 mg/L) or higher (SIDS (2009)).
 Therefore, this substance was classified in Category 1 (respiratory organs).
 Besides, it is reported that in a single oral exposure test using rats, apathy, dyspnoea, and diarrhea were observed at 200 mg/kg of near the lethal dose (SIDS (2009)).
 In addition, it is reported that dibutyltin oxide (CAS RN 818-08-6), dibutyltin maleate (CAS RN 78-04-6) and dibutyltin bis(2-ethylhexyl thioglycolate) (CAS RN 10584-98-2) undergo hydrolysis in artificial gastric juice and convert to this compound (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)).
 Moreover, it is reported that this compound, dibutyltin dilaurate (CAS RN 78-04-6), dibutyltin maleate, dibutyltin bis(2-ethylhexyl thioglycolate) and dibutyltin bis(isooctyl thioglycolate) (CAS RN 25168-24-5) are hydrolyzed to form dibutyltin oxide (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, immune system)


Danger
H372 P260
P264
P270
P314
P501
 No information in humans is available.
 As for the experimental animals, it is reported that in a 2-week repeated dose toxicity study using rats by feeding, effects on the immune system (decrease in relative weight of thymus, spleen and popliteal lymph nodes, and thymic atrophy) were observed at 0.005% (converted guidance value: 0.39 mg/kg/day), which is equivalent to Category 1, and effects on the liver (decrease in relative liver weight, severe proliferation of bile duct epithelial cells with pericholangitis or biliary fibrosis) and effects on the immune system (lymphoid depletion in thymus cortex) were observed at 0.015% (converted guidance value: 1.17 mg/kg/day) (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), CICAD 73 (2006)).
 In addition, likewise, in the 4-week or 6-week repeated dose toxicity test using rats administered by feeding, within the range of Category 1, depleted of lymphocytes in the thymus cortex, decrease in antibody response to sheep red blood cells and delay (decrease) in allograft rejection response for skin graft of tails from other rats etc. are reported (Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010), CICAD 73 (2006), PIM 586 (1994)).
 Therefore, this substance was classified in Category 1 (liver, immune system).
 In addition, it is reported that dibutyltin oxide (CAS RN 818-08-6), dibutyltin maleate (CAS RN 78-04-6), dibutyltin bis(2-ethylhexyl thioglycolate) (CAS RN 10584-98-2) undergo hydrolysis in artificial gastric liquid and converted to this compound (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)).
 Moreover, it is reported that this compound, dibutyltin dilaurate (CAS RN 78-04-6), dibutyltin maleate, dibutyltin bis(2-ethylhexyl thioglycolate) and dibutyltin bis(isooctylthioglycolate) (CAS RN 25168-24-5) are hydrolyzed to form dibutyltin oxide (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)).
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 1


Warning
H400 P273
P391
P501
 From 96-hour ErC50 = 0.04 mg/L for algae (Scenedesmus obliquus) (CICADs 73, 2006), it was classified in Category 1
11 Hazardous to the aquatic environment (Long-term) Category 1


Warning
H410 P273
P391
P501
 Due to being not rapidly degradable (BIOWIN), and 21-day NOEC = 10.5 microg/L for crustacea (Daphnia magna) (SIDS, 2006), it was classified in Category 1.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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