Latest GHS Classification Results by the Japanese Government (edited by NITE)

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 110-65-6
Chemical Name 2-Butyne-1,4-diol
Substance ID m-nite-110-65-6_v1
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) To Guidance List
UN GHS document (External link) To UN GHS document
FAQ(GHS classification results by the Japanese Government) To FAQ
List of Information Sources (Excel file) List of Information Sources
List of Definitions/Abbreviations Definitions/Abbreviations
Sample Label by MHLW (External link) MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) To OECD/eChemPortal (External link)

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Explosives Not classified
-
-
- - Although including unsaturated C-C bonds, it is classified into Division 6.1, PGIII in UNRTDG (UN2716). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
7 Flammable solids Classification not possible
-
-
- - It is reported as flammable (ICSC (J) (2008)), but classification is not possible due to lack of additional data. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
8 Self-reactive substances and mixtures Type G
-
-
- - Although there are chemical groups (unsaturated C-C bonds) present in the molecule associated with self-reactive properties, the substance is classified into Division 6.1, PGIII in UNRTDG (UN2716), therefore it was judged that this substance is Type G. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
10 Pyrophoric solids Not classified
-
-
- - Since its auto ignition point is 335 degC (Ullmanns (E) (6th, 2003)), it is considered that the substance does not ignite at room temperature. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to solid (melting point <= 140 degC) substances are not available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (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). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing oxygen which is chemically bonded only to carbon or hydrogen. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
17 Desensitized explosives -
-
-
- - - - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Acute toxicity (Oral) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
Based on the rat LD50 values of 132 mg/kg bw (male) and 176 mg/kg bw (female) (EU RAR54 (2005)), the substance was classified into Category 3. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
The three LD50 values for rats (424 mg/kg bw, 983 mg/kg bw and 1240 mg/kg bw) were documented (EU-RAR 54 (2005)). Since the two data are equivalent to the guidance value of Category 3 and the other is Category 4, the substance was classified as Category 3. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Dusts and mists) Category 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
Based on the rat LC50 value of 0.69 mg/L/4h (EU-RAR 54 (2005)), the substance was classified into Category 3. According to the description of liquid aerosol for the test substance, criterion value for dust/mist was adopted. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
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
In the rabbit test (OECD TG 404) treated 6 animals with 0.5 g for 4 hours, severe erythema and severe edema within 24 hours, and necrosis within 6 days were noted in all animals. Based on the information, the substance was classified as Category 1. The substance was classified as "R34" in the EU classification (EU-Annex I (Access on May 2010)) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
In the rabbit tests (OECD TG 405), instillation of 100 mg of test substance caused moderate irritation of iris, cornea and conjunctivae in all 6 rabbits, and 1/6 rabbits exhibited irreversible corneal opacity (EU-RAR 54 (2005)). Based on these information, the substance was classified into Category 1. As for this substance, skin corrosion was also reported (EU RAR 54 (2005)). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Respiratory sensitization Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
Dermatitis developed by the occupational exposure and positive reaction of patch tests were reported. There were many documents that the substance is allergenic (EU-RAR 54 (2005)). The substance was classified as "R43" in the EU classification (EU-Annex I (Access on May 2010)). Based on these documents, the substance was classified as Category 1. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
5 Germ cell mutagenicity Not classified
-
-
- - The substance was classified as "Not classified" based on the negative results in the micronucleus test using bone marrow cells by intraperitoneal administration to mice (in vivo mutagenicity test in somatic cells) (EU-RAR 54 (2005)). As relevant information, as for in vitro studies, negative results in the Ames test (NTP DB (Access on May 2010)) and equivocal results in the chromosomal aberration test using V79 cells (EU-RAR 54 (2005)) were reported. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
6 Carcinogenicity Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
7 Reproductive toxicity Not classified
-
-
- - In the one-generation reproductive study (OECD TG415) in which male and female rats were administered via drinking water during the period of premating, mating, gestation and lactation, signs of developmental retardation (impaired postnatal weight gain associated with a delay in sexual maturation) were observed in the F1 progeny at the dose level causing general toxicity to parent animals. However, there was no adverse effect on reproductive ability and no indication of adverse impairment in reproductive organs for both sexes, spermatic indices for males and estrous cycle for females (EU-RAR 54 (2005)). In the developmental toxicity study (OECD TG 414) using pregnant rat administered orally during the organogenetic period, no substance-related impairment was observed in gestational parameters, fetal viability, gross morphological appearance. Embriotoxic, fetotoxic or teratogenic potential was not identified (EU-RAR 54 (2005)). As mentioned above, in the study that conforms to the OECD guidelines, there were no adverse effects on sexual functions and fertility of parental animals, and development of offspring. Therefore, the substance was classified as "Not classified". FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
8 Specific target organ toxicity - Single exposure Category 1 (systemic)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
It was reported that the main clinical signs of toxicity appeared after oral treatment in rats were apathy, dysequilibrium, convulsions, tremors, etc. (EU-RAR 54 (2005)), while there was no concern of the substance affecting on the nervous system according to all data obtained at present (EU-RAR 54 (2005)). In rats applied dermally up to 5000 mg/kg, the changes in livers and kidneys demonstrated severe hyperemia and degeneration containing necrosis (EU-RAR 54 (2005)), which were the findings observed at higher doses beyond the upper limit of the guidance values. Otherwise, respiratory effects were also noted in both inhalation and dermal exposure (EU-RAR 54 (2005)). As stated above, it was difficult to identify the target organ(s) and the values of LD50 or LC50 were ranged within Category 1 of the guidance values. Thus, the substance was classified as Category 1 (systemic toxicity). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
9 Specific target organ toxicity - Repeated exposure Category 1 (hematopoietic system, liver), Category 2 (kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
In the 28-day oral study in rats, significantly decreased corpuscular indices suggesting anemia, mononuclear cell infiltration and numerous megakaryocytes in the red pulp of the spleen were observed at 10 mg/kg/day (converted dose level as that of 90-day study: 3.1 mg/kg/day (equivalent to Category 1)) or more (EU-RAR 54 (2005)). In addition, microscopic examination revealed the liver lesions at 10 mg/kg/day (converted dose level as that of 90-day study: 3.1 mg/kg/day (eq. Category 1)) or more, which consisted of hypertrophy of parenchymal cells, increased polymorphonuclear hepatocytes, some parenchymal cells with macronucleus and chromatin margination, etc. (EU-RAR 54 (2005)). Furthermore, in histopathology of the animals that died at 50 mg/kg/day (converted dose level as that of 90-day study: 15.6 mg/kg/day (eq. Category 2)), renal tubular degeneration and interstitial mononuclear cell infiltration in the kidney were noted (EU-RAR 54 (2005)). As described above, the main toxicity appeared in hematopoietic systems, liver, and kidneys, and with reference to the guidance values from the doses appeared, the substance was classified as Category 1 (hematopoietic systems, liver) and as Category 2 (kidney). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
10 Aspiration hazard Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
11 Hazardous to the aquatic environment Short term (Acute) Category 3
-
-
H402 P273
P501
Classified into Category 3 from its 48h-EC50 = 26.8 mg/L for crustacea (Daphnia magna) (EU-RAR, 2005). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Hazardous to the aquatic environment Long term (Chronic) Not classified
-
-
- - Classified as "Not classified" since it is rapidly degradable (DOC degradation rate tested by OECD 301: 100% (EU-RAR, 2005)) and its bioaccumulation potential is estimated to be low (Log Kow = -0.93 (PHYSPROP Database, 2009)) though its acute toxicity is Category 3. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in Annexes to the Montreal Protocol. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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