GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 68648-93-1
Chemical Name Mixture of bis[alkyl(C=6,8,10)] phthalate
Substance ID H28-A-007, C-018A
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
-
-
- -  Liquid (GHS definition)
3 Aerosols Not applicable
-
-
- -  Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- -  Liquid (GHS definition)
5 Gases under pressure Not applicable
-
-
- -  Liquid (GHS definition)
6 Flammable liquids Not classified
-
-
- -  A flash point is 246 deg C (CPSC Staff Toxicity (2010)).
7 Flammable solids Not applicable
-
-
- -  Liquid (GHS definition)
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 Classification not possible
-
-
- -  No data available.
10 Pyrophoric solids Not applicable
-
-
- -  Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- -  Test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- -  The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- -  The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable
-
-
- -  Liquid (GHS definition)
15 Organic peroxides Not applicable
-
-
- -  Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- -  No data available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- -  Based on a report of an LD50 value of > 10,000 mg/kg for rats (PATTY (6th, 2012)), the substance was classified as "Not classified."
1 Acute toxicity (Dermal) Classification not possible
-
-
- -  Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- -  Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
3 Serious eye damage/eye irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
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 Classification not possible
-
-
- -  Classification not possible due to lack of data.
6 Carcinogenicity Classification not possible
-
-
- -  There is no information on the carcinogenicity of this substance, and there is no data available for classification on any of the components with an alkyl carbon number of 6, 8, or 10. Therefore, the classification is not possible due to lack of data.
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
 There are no experimental data for this substance (mixture). Among the individual components, for bis(n-hexyl) phthalate which is C6, in a continuous breeding test (administration by feeding) in mice by NTP, decreases in pregnancy rate and the number of live pups/litter were observed at 3,000 ppm (equivalent to 380 mg/kg/day) or more. As a result of crossover mating using females/males of the high-dose group at 12,000 ppm (equivalent to 1,670 mg/kg/day) and females/males of the control group, all pairs of a treated female/male and a control male/female were effectively infertile (treated female x control male pairs were all infertile; for treated male x control female pairs, only one out of eighteen cases became pregnant). Toxicity to the testis (reduced epididymal sperm count and motility) was observed in the high-dose males (CPSC (2010)). From the above, bis(n-hexyl) phthalate is thought to be a clear reproductive toxicant (equivalent to 1B) in experimental animals. On the other hand, for bis(n-octyl) phthalate which is C8, in a continuous breeding test in mice by NTP, no effects were seen on fertility at up to 7,500 mg/kg/day (ECHA Review Report (2010)). Besides, there is no available data on bis (n-decyl) phthalate which is C10.
 As above, since this substance (a mixture of phthalates of C=6, 8, 10) is considered to be a mixture containing the threshold value of 0.3 % or more of bis(n-hexyl) phthalate, C6, which can be determined to be a clear reproductive toxicant (equivalent to 1B) in experimental animals, this substance was classified in Category 1B according to the GHS Classification Guidance for mixtures (the GHS Classification Guidance for Enterprises). Besides, for this substance, the EU classified a mixture containing 0.3% or more of bis(n-hexyl) phthalate as Repr. 1B and designated it as SVHC (ECHA (2015)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- -  Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  Classification not possible due to lack of data.
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) Classification not possible
-
-
- -  No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- -  No data available.
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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