NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	9016-45-9
Chemical Name	Poly(oxyethylene) nonylphenyl ether
Substance ID	H28-B-03-METI, M-003B
Classification year (FY)	FY2016
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2007 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) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), when the mole number of ethylene oxide added (hereinafter, referred to as EO) is 9.5. Changed to a solid from a liquid when EO is increased).
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), when EO = 9.5).
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), when EO = 9.5).
6	Flammable liquids	Not classified (when polymerization degree of ethylene oxide is 9.5)	- -	-	-	Based on a flash point of 282 deg C (when EO = 9.5) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)), it was classified as "Not classified."
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), when EO = 9.5).
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) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), when EO = 9.5).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available (when EO = 9.5).
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) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), when EO = 9.5).
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)	Classification not possible	- -	-	-	Theoretically, there are more than 100 types of isomers of this substance due to the differences in branching and substitution positions of nonyl groups. In this classification, the added molar number of ethylene oxide (EO) was specified when there is a description in the information source. Classification not possible due to lack of data. There is a marked difference in the LD50 value of this substance since the chain length of this substance varies depending on the added molar number of EO. The LD50 values of 1,300 mg/kg (EO 10), 1,800 mg/kg (EO 9), 1,980 mg/kg (EO 6), 2,500 mg/kg (EO 15), 4,300 mg/kg (EO 4) (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)) were reported, and each value corresponds to Category 4, Category 4, Category 4, "Not classified" (Category 5 in UN GHS classification), "Not classified" (Category 5 in UN GHS classification), respectively. Besides, in Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), which was used for the previous classification, it is described that LD50 values for rats are 1,300 - 7,400 mg/kg for EO 2 - 15 and 15,900 mg/kg for EO 20, and these correspond to Category 4 - "Not classified" and "Not classified," respectively. However, the classification was not possible because the category coule not be determined by these values alone.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is a marked difference in the LD50 value of this substance since the chain length of this substance varies depending on the added molar number of EO. Besides, it is described that the LD50 value of rabbits used in the previous classification was 1,800 to more than 10,000 mg/kg for EO 4-10 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), and these correspond to Category 4 - "Not classified." However, the classification is not possible because the category cannot be determined by these values alone.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition) (in the case of EO 9.5) (Hazard Assessment Report (CERI, NITE, 2007)).
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	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In the multiple reports in which this substance was applied to volunteers, skin irritation caused by this substance was reported, therefore, it is stated that this substance shows skin primary irritation to humans (Hazard Assessment Report (CERI, NITE, 2007)). Besides, it was reported that in the skin irritation test using rabbits, application of EO 2-9 showed moderate to strong irritation and application of undiluted solution of EO 10 or more showed no irritation to mild irritation (Hazard Assessment Report (CERI, NITE, 2007)), but the details of the test such as application time were unknown. From the above, based on the description that it shows primary irritation in humans, it was classified in Category 2.
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In the eye irritation test using rabbits, it was reported that moderate to strong irritation was exhibited by applying undiluted solution of EO 2-15 (Hazard Assessment Report (CERI, NITE, 2007)). From the above, this substance was classified in Category 2A.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	In a maximization test using guinea pigs, it was reported that as a result of application of this substance (EO 6), it did not show sensitization (Hazard Assessment Report (CERI, NITE, 2007)). Also, there are multiple reports of patch tests on volunteers, and it is reported that they showed sensitization by applying 10% of this substance (EO 2) (Hazard Assessment Report (CERI, NITE, 2007)), a small number of people showed sensitization to this substance (EO 4 or 9) (Hazard Assessment Report (CERI, NITE, 2007), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). It is written in Hazard Assessment Report (CERI, NITE, 2007) that based on these reports, the possibility of this substance with EO 10 or less showing skin sensitization is high. However, since the details of the test conditions and etc. are unknown in any of the reports, they were judged to be not sufficient to use for classification, and the substance was classified as "Classification not possible."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible," because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo test, this substance which added molar number of EO is 9 - 12 were negative in a mouse dominant lethal test, micronucleus tests using mouse bone marrow cells (Hazard Assessment Report (CERI, NITE, 2007)), and as for in vitro test, it was negative in bacterial reverse mutation tests, a mammalian cell chromosomal aberration test (Hazard Assessment Report (CERI, NITE, 2007), Safety Test (Ministry of Economy, Trade and Industry (METI), Access on September 2016).
6	Carcinogenicity	Classification not possible	- -	-	-	In a 2-year carcinogenicity studies dosed in diet, in which NPE (EO 4) was administered to both male and female rats or both male and female dogs at up to 1,000 mg/kg/day, and in which NPE (EO 9) was administered to male rats at up to 140 mg/kg/day and to both male and female dogs at up to 88 mg/kg/day, no dose-dependent carcinogenesis was observed in either case (Hazard Assessment Report (CERI, NITE, 2005)). In a promoter test using N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) as carcinogen initiator, after oral administration of drinking water containing 100mg/L of MNNG and 2,000 mg/L of NPE (the added molar number of EO is unknown) for 36 weeks to male rats, the incidence of tumor of glandular stomach was 12/15 (80%) for the group dosed with MNNG + NPE versus 8/13 (62%) for the control group dosed with only MNNG, and the incidence of small intestinal tumor was 7/15 (47%) for the group dosed with MNNG + NPE versus 1/13 (7.7%) for the control group dosed with only MNNG. From these results, it was concluded that NPE has tumor promoting effect (Hazard Assessment Report (CERI, NITE, 2005)). From the above, although it is considered that there is no carcinogenicity in NPE (EO 4) or NPE (EO 9), the possibility that this substance has a promoter action is pointed out, and thus, it was determined that the data were not enough to classify this substance as "Not classified." Therefore, the substance was classified as "Classification not possible" for this hazard class.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the developmental toxicity test in which this substance with 9 added moles of EO (EO 9) was dosed by gavage to pregnant rats during organogenesis (gestation 6-15 day) or the entire gestation period (gestation 1-20 day), as for the administration during organogenesis, suppression of body weight gain and a decrease in the litter size were observed in the maternal animals and extra ribs were observed in the fetus at doses of 250 mg/kg/day or more. On the other hand, in the case of total gestation administration, dilatation of the pelvic cavity in the fetus of the group of 500 mg/kg/day was only observed (Hazard Assessment Report (CERI, NITE, 2007), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). Therefore, since the litter size decreased at the dose with the expression of maternal toxicity, this substance was classified in Category 2 for this hazard class. Besides, it was reported that a single injection of EO 9 into uterine horns of pregnant rats on the first day of pregnancy and cesarean section at 8 - 12 days of pregnancy resulted in a decrease in pregnancy rate and average embryo number in the 0.5 mg/animal infusion group (Hazard Assessment Report (CERI, NITE, 2007), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)), and it was also reported that in the case of intravaginal administration of NPE 9 (50 mg/kg) to pregnant rats on 3rd or 7th day of gestation and caesarean section at 6-15 days of pregnancy or 8-15 days of pregnancy, a decrease in the number of implantation of embryos and an increase in the number of absorbed embryos were observed (Hazard Assessment Report (CERI, NITE) (2007)).
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	- -	-	-	No data available for humans. As for experimental animals, multiple tests using rats and dogs have been carried out on this substance with different added molar numbers of EO. The liver weight gain was seen within the range of up to Category 2 in many cases, and hepatocyte degeneration accompanied by lipid deposition, focal necrosis of hepatocytes and necrosis of renal tubules etc. have been observed at doses exceeding Category 2 (Hazard Assessment Report (CERI, NITE, 2007), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). Besides, it was reported that in a 90-day repeated dose toxicity study of EO 4, 6, 15, 20 and 30 administered by diet, localized necrosis of cardiac muscle was observed for only EO 20 (Hazard Assessment Report (CERI, NITE, 2007), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). As for this result, the similar finding was not observed in a similar study of dogs using EO 4 or EO 9, by the same author, a longer term study dosed by diet (2-year repeated dose toxicity study). Moreover, the similar result was not observed in the similar test using rats by the same author (a 90-day repeated dose toxicity test using rats given EO 4, 6, 15, 20, 30 by diet). Furthermore, the similar finding was not observed in multiple tests using rats (tests using rats and EO 4, 9, 40) (Hazard Assessment Report (CERI, NITE, 2007), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). From the above, because the effect on the cardiovascular system was observed only in the dogs given EO 20 and the same result was not seen in rats, it was considered that it would not be seen in this substance (EO ca. 10), and it was considered not appropriate to determine it as the target organ. Therefore, because there is no sufficient effect for classification within a range of Category 2, and no information available on other routes, etc., the substance was classified as "Classification not possible."
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 48-hour LC50 (NPE9, branched) = 0.71-2.2 mg/L for crustacea (Mysidopsis bahia) (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	Because it is not rapidly degradable (a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1982)), and its 7-day NOEC (growth) (NPE9) = 1 mg/L for fish (Pimephales promelas) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)), 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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