GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 2426-08-6
Chemical Name n-Butyl 2,3-epoxypropyl ether
Substance ID H28-B-021, C-029B
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
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 Category 3


Warning
H226 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
 Based on a flash point of 54 deg C (closed cup) (ICSC(J) (2005)), it was classified in Category 3.
7 Flammable solids Not applicable
-
-
- -  Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible
-
-
- -  There is a chemical group associated with self-reactive properties (strained ring (epoxides)) present in the molecule, but the classification is not possible due to no data.
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
-
-
- -  It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to elements other than 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 the LD50 values of 2,050 mg/kg (HSDB (Access on May 2016)) and 2,260 mg/kg (ACGIH (7th, 2001, 2014), PATTY (6th, 2012), NTP (2004), HSDB (Access on May 2016)) for rats, this substance was classified as "Not classified" (Category 5 of UN GHS classification).
 Along with the revision of the GHS classification guidance for the Japanese Government, the classification was changed.
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
 There are reports of LD50 values for rabbits of 788 mg/kg (NTP (2004), PATTY (6th, 2012), HSDB (Access on May 2016)) and 4,930 mg/kg (ACGIH (7th, 2001, 2014), NTP (2004), PATTY (6th, 2012)).
 One case is equivalent to Category 3, and one case is equivalent to "Not classified." The category with higher hazard was adopted, and this substance was classified in Category 3.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
 Based on reports of LC50 values of 670 ppm (8 hours) (converted 4-hour equivalent value: 948 ppm) (ACGIH (7th, 2001, 2014)) and 1,030 ppm (8 hours) (converted 4-hour equivalent value: 1,457 ppm) (NTP (2004), PATTY (6th, 2012)) for rats, this substance was classified in Category 3.
 Note that it was judged that the mist was not present since these values are lower than 90% of the saturated vapor pressure concentration (4,245 ppm), so the reference value of the gas was applied.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
 As for effects on humans, since it is described that it is irritating to the skin (ACGIH (7th, 2001), DFGOT vol.4 (1992), PATTY (6th, 2001)), this substance was classified in Category 2.
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
 As for effects on humans, since it is described that it is irritating to the eyes (ACGIH (7th, 2001), DFGOT vol.4 (1992), PATTY (6th, 2001, 2012)), this substance was classified in Category 2B.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
 There are descriptions that sensitization was observed in two skin sensitization tests for humans (DFGOT vol. 4 (1992)) and that skin sensitization has been reported in humans (PATTY (6th, 2012)). In addition, because there are many reports that skin sensitization has been recognized for humans and animals, this substance is classified as Dermal Sensitizer (DSEN) in ACGIH (7th, 2014).
 Therefore, this substance was classified in Category 1.
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
 As for in vivo, positive and negative findings are reported in micronucleus tests using mice, and a chromosomal aberration test using rat bone marrow cells is positive (ACGIH (7th, 2014), PATTY (6th, 2012), Health Canada and Environment Canada (2010), NTP (2004)). As for in vitro, a bacterial reverse mutation test and a mouse lymphoma assay in mammalian cells are positive (ACGIH (7th, 2014), PATTY (6th, 2012), NTP (2004), Health Canada and Environment Canada (2010), NTP DB (Access on June 2016)). From the above, this substance was classified in Category 2 based on the GHS classification guidance for the Japanese Government.
 Additionally, there are several reports of dominant lethal assays using mice in vivo (Environment Canada/Health Canada (2010), ACGIH (7th, 2014), NTP (2004)). However, the reproducibility of the data is poor, there are problems and contradictions in the test conditions etc., and highly reliable evaluation results have not been obtained.
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
 In a 2-year inhalation exposure carcinogenicity study of this substance using rats or mice, in rats, squamous cell carcinomas, adenosquamous carcinomas, nasal neuroepithelioma and adenomas, etc. in the nasal cavity were observed; and in mice, hemangiomas in the nasal cavity and some rare cases of squamous cell carcinomas were observed (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on May 2016)). As for classifications by other organizations, the EU classifies this substance as Carc. 2 (ECHA CL Inventory (Access on May 2016)), and the Japan Society For Occupational Health (JOSH) has proposed classification in Group 2B (OEL Documentations (2016)).
 From the above, this substance was classified in Category 1B since clear evidence of carcinogenicity in the two species of experimental animals was observed. In addition, this substance is one of the substances announced in association with the guidelines to prevent health problems based on the provisions of Article 28, Paragraph 3 of the Industrial Safety and Health Law.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
 It is described that in a 10-week inhalation study using male rats, atrophy of the testes was observed at 400 mg/m3 (75 ppm) or above (NTP Review of Toxicological Literature (2004), Environment Canada/Health Canada (2010), ACGIH (7th, 2014), OEL Documentations (2016)).
 It is described that in a study in which untreated female mice were mated with male mice dermally exposed to 1500 mg/kg 3 times/week for 3 weeks, decreases in pregnancy rates and in the number of implants and an increase in fetal death rates were observed (Screening Assessment for the Challenge (Environment Canada/Health Canada (2010), ACGIH (7th, 2014), OEL Documentations (2016)). Moreover, it is described that in a study involving pregnant rats dosed by gavage during gestation days 0-19 at doses of up to 250 mg/kg/day, fetal hypoplasia and reductions in fetal number and in the implantation rate were observed (OEL Documentations (2016)), and the Japan Society For Occupational Health classifies this substance as Group 3 in Reproductive Toxicants based on the limited evidence in experimental animals (OEL Documentations (2016)). Therefore, this substance was classified in Category 2 for this hazard class.
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation)


Warning
H335 P304+P340
P403+P233
P261
P271
P312
P405
P501
 It is reported that inhalation of this substance was found to be irritating to the respiratory tract in humans (DFGOT vol. 4 (1992)). Therefore, this substance was classified in Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs), Category 2 (genetic organs (men))


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
 There is no information on humans.
 As for experimental animals, it is reported that in a 28-day repeated inhalation toxicity study using rats, degeneration of the nasal mucosa and hyperplastic-metaplastic lesions in the ciliated epithelium of the respiratory tract were observed at 92.5 ppm (converted guidance value: 0.15 mg/L), which is within the range of Category 1 (DFGOT vol.4 (1992), PATTY (6th, 2012)).
 In addition, it is reported that in a 10-week repeated inhalation toxicity study using rats, atrophy of the testes (slight patchy atrophy) was observed at 75 ppm (converted guidance value: 0.25 mg/L), which is within the range of Category 2 (DFGOT vol.4 (1992), PATTY (6th, 2012), ACGIH (7th, 2014)).
 Therefore, this substance was classified in Category 1 (respiratory organs) and Category 2 (genetic organs (men)).
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 2
-
-
H401 P273
P501
 From 48-hour EC50 = 2 mg/L for crustacea (Acartia tonsa) (AQUIRE, 2016), it was classified in Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2


-
H411 P273
P391
P501
 Reliable chronic toxicity data were not obtained. Due to not rapidly degradable (a degradation rate by BOD: 40% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1986)), and acute toxicity Category 2, it was classified in Category 2.
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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