NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	25154-52-3
Chemical Name	Nonylphenol
Substance ID	H28-B-063, C-142B
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	Not classified	- -	-	-	Based on a flash point of 141 deg C (closed-cup) (GESTIS (Access on November 2016)), it was classified as "Not classified."
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	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 370 deg C (GESTIS (Access on November 2016)).
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Three values are reported as LD50 values for rats: 1,200 - 2,400 mg/kg (male, EU-RAR (2002)), 1,600 - 1,900 mg/kg (female, EU-RAR (2002)), 1,300 - 2,462 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), SIAP (2001)). These correspond to Category 4 - "Not classified," Category 4, and Category 4 - "Not classified," respectively. On the basis of these, this substance was classified in Category 4 by adopting the category with higher hazard. Besides, the Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not used for the classification because it is information source listed in List 3.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the LD50 values of 2,031 mg/kg (EU-RAR (2002)), > 2,000 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), this substance was classified as "Not Classified." Besides, the Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not used for the classification because it is information source listed in List 3.
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	Category 1C	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 changes suggesting corrosiveness, such as full-thickness necrosis and ulceration etc. were found with 4 hour application in skin irritation tests using rabbits (three tests according to OECD TG 404, one test with unknown details), and in addition, that in the two tests of them, slight to severe irritation was observed in the groups ranged from 3-minute to 1-hour application, however, necrosis etc. suggesting corrosiveness were not observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2002)). Elsewhere, it was reported that moderate to severe irritation was observed also in the skin irritation tests (two tests according to OECD TG 404, one test with unknown details) using rabbits (two tests according to OECD TG 404, one test with unknown details) using rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2002), CEPA (2001)). From the above results, this substance is considered to have corrosiveness, but the corrosiveness was not observed by 3-minute to 1-hour application. Therefore, this substance was classified in Category 1C.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In rabbit eye irritation tests (OECD TG 405), conjunctival redness (score 3) and corneal opacity (score 3 or 4) are observed, and severe irritation is reported (EU-RAR (2002)). In addition, moderate to severe irritation is reported in rabbit eye irritation tests though the details are unknown (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), CEPA (2001)). 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	Not classified	- -	-	-	In skin sensitization tests using guinea pigs (three maximization tests containing OECD TG 406), this substance was not shown to be a skin sensitizer (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2002), SIAP (2001)). In addition, it is noted that this substance was negative in a skin sensitization test using guinea pigs though the details are unknown (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Therefore, this substance was classified as "Not Classified."
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, negative is observed in a micronucleus test using bone marrow cells of mice (EU-RAR (2002)); as for in vitro, negative results have been reported in a bacterial reverse mutation test and a gene mutation test and chromosome aberration test using mammalian cultured cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), (JECDB (Access on October 2016), EU-RAR (2002)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a three-generation test using rats dosed in the diet, at doses (50 - 160 mg/kg/day) at which the effects of general toxicity (decreased weight gain, decreased relative kidney weight, and renal tubular degeneration) were observed in F0 - F2 parental animals, accelerated timing of vaginal opening, increased uterus weight, decreased ovarian weight , increase in the estrous cycle (F1, F2), decrease in epididymal sperm density and decrease in testicular spermatid were observed in F1 - F3 pups (EU-RAR (2002)). In addition, in a two-generation test using rats, at the dose (50 mg/kg/day) at which increases in the weights of kidney and liver (males) and decrease in ovary weight (females) were observed in F0 and F1 parental animals, a decrease in survival rate, an accelerated timing of vaginal opening, a decrease in the number of implantations in F1 pups, and a decrease in live F2 pups were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). From the above, in the two- and three-generation tests using rats, at doses at which the effects of general toxicity are largely observed in parent animals, effects on the next generations such as effects on sexual function/genetic organs and decrease in survival rate are observed in pups, and it was considered appropriate to classify this substance in Category 2 for this hazard class. In addition, the EU classifies this substance as "Repr. 2" (ECHA C&L Inventory (Access on October 2016)). Additionally, in the previous classification, this substance was classified in Category 1B because, in a three-generation reproductive toxicity test, effects on pups were observed at a dose in which no toxic effects were observed in parental animals. This time, however, as a result of researching in the different information sources, it was confirmed that the effects on the pups are observed at doses at which toxic effects on the parent animals are observed in a three-generation reproductive toxicity test. Therefore, the category was changed.
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	As for humans, it is described that this substance indicates irritation of the respiratory system (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), and a slight smarting is caused to the eyes and respiratory system by the exposure to vapors of this substance in high concentrations (HSDB (Access on October 2016)). As for experimental animals, in a single inhalation exposure test, it is reported that high concentration of this substance indicated respiratory tract irritation (EU-RAR (2002)). From the above, this substance was classified in Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney, urinary bladder)	Warning	H373	P260 P314 P501	There is no information in humans. As for experimental animals, in a 28-day repeated dose toxicity study using rats dosed by gavage, at 250 mg/kg/day (converted guidance value: 77.8 mg/kg/day), which is equivalent to Category 2, liver weight increase, centrilobular hepatocellular hypertrophy , kidney weight increase, basophilic change and single cell necrosis of the proximal tubule in the corticomedullary junction of the kidney, cellular infiltration of stroma, casts, basophilic change and dilatation of collecting tubules, simple hyperplasia of renal pelvic mucosa, pelvic dilatation, and simple hyperplasia of the transitional epithelium of the urinary bladder were observed. (JECDB (Access on October 2016), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). As for the liver, it was not adopted as the target organ because only hepatocellular hypertrophy was observed. Therefore, this substance was classified in Category 2 (kidney, urinary bladder).
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 EC50 = 0.0207 mg/L for crustacea (Hyalella azteca) (EU-RAR, 2002; Initial Risk Assessment (NITE, CERI, NEDO, 2005); SIAP (Conclusions Agreed in SIAM 12, 2001)), 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 (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and 28-day NOEC (growth) = 0.0039 mg/L for crustacea (Mysidopsis bahia) (CEPA, 2001; EU-RAR, 2002; Initial Risk Assessment (NITE, CERI, NEDO, 2005); SIAP (Conclusions Agreed in SIAM 12, 2001)), 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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