NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	84852-15-3
Chemical Name	4-Nonylphenol (branched)
Substance ID	m-nite-84852-15-3_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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (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)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified	- -	-	-	Its flash point reported 155 degC (closed-cup) (IUCLID (2000)) is >= 93 degC.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	Since its auto ignition point is about 370 degC (industrial substance mainly containing p-isomer) (Hommel (1996)), it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid 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)	- -	-	-	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）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	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	- -	-	-	No data available. As relevant note, stainless steel is durable as a container (Hommel (1996)).	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 4	Warning	H302	P301+P312 P264 P270 P330 P501	The one LD50 value for rats of 580 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment vol. 2 (2003)), which was the data from the "List 1" information source designated in the GHS classification guidance for the Japanese government was reported. And three LD50 values (1900 mg/kg, 1882 mg/kg and 1246 mg/kg) from studies which were complying with the test guidelines (OECD TG 401 or USA IRLG Guideline) (IUCLID (2000)), which was the "List 2" information designated in the same guidance mentioned above, were reported. All data were equivalent to Category 4, the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rabbit LD50 value of 2037 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment vol.2 (2003)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification). For further information, another rabbit LD50 values of > 2000 mg/kg (IUCLID (2000)) was documented.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (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)	Classification not possible	- -	-	-	No data available.	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), occlusive administration of 0.5 ml of test substance caused mild to moderate erythema, and mild to moderate edema at 3 minutes of exposure, moderate erythema and severe edema at 4 hours, subsequently, epidermal necrosis, full-thickness skin necrosis, fissure, exfoliation, ulceration, loss of hair, crust formation and cicatrization were observed. The substance was classified as Category 1 since the symptoms were not reversible (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In the rabbit test, instillation of 0.1 ml or 100 mg of the substance caused moderate to severe irritation (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)). In another rabbit test (OECD TG405), irritation was caused and irritation score was 38.42/110 (IUCLID (2000)). Based on these documents, the substance was classified as Category 2. Pre-existing classification for skin corrosion/irritation is Category 1.	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	Classification not possible	- -	-	-	In EU-RAR 10 (2002), three guinea pig maximization tests were reported. Two cases reported that the substance was non-sensitizing, and the other case was inconclusive because of the defect of test methods. In Initial Risk Assessment Report (Ver.1.0, No.1, NITE, CERI, NEDO) (2005), there were 5 reports in which the substance was concluded as non-sensitizing excepting the studies that have defects of test methods. Thus, there were no clear conclusion about sensitization in the information source, the substance was classified as "Classification not possible".	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 the bone marrow cells of mice (in vivo mutagenicity test in somatic cells) in both administrations with intraperitoneal and oral (EU-RAR (2002)). As relevant information, as for in vitro studies, negative results in the Ames test and in the chromosome aberration test using CHL cells (Initial Risk Assessment Report (NITE, CERI, NEDO) (2005)) as well as the HPRT gene mutation test (OECD TG 476) using Chinese hamster V79 cells (EU-RAR (2002)) 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	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the two-generation reproductive toxicity study by oral administration in rats, effects of reproductive parameter such as decrease in the number of implantation and live pups were observed at the dose level (50 mg/kg/day) causing general toxicity (increases in weights of the liver and kidney) in parental animals (Initial Environment Risk Assessment of Chemicals (Ministry of Environment), vol. 2 (2003)). Therefore, the substance was classified as Category 2. As relevant information, in the three-generation reproductive toxicity study by oral administration using rats, there were no adverse effects on sexual functions and fertility of parents and developmental indices for litter were observed, however prolongation of the estrus cycle and accelerated vaginal opening in females, decreased testicular spermatid counts in males were reported (NTP TR (1997)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	Based on the reports that the clinical signs after oral administration in rats included sedation, ataxia, and lethargy, etc. (Initial Risk Assessment Report (NITE, CERI, NEDO (2005)), EU-RAR (2002)), the substance was classified as Category 3 (narcotic effects). Additionally, from a description that in mice exposed to saturated vapor, irritating effects on the respiratory system were observed (EU-RAR (2002)), the substance was classified as Category 3 (irritation in the respiratory tract). Besides, it was also reported that inflammatory changes in the gastrointestinal tract (Initial Risk Assessment Report (NITE, CERI, NEDO (2005))) and an erosion of the mucosal surface of the stomach (EU-RAR (2002)) were observed in dead animals. But the information was not adopted as evidence to classify because these were considered as local effects by corrosive/irritating property of this substance.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	In the 28-day repeated dose oral toxicity study in rats, the findings noted at 250 mg/kg/day (converted dose level as that of 90-day study: 77.8 mg/kg/day) included centrilobular hypertrophy of hepatocytes, basophilic cytoplasm in renal proximal tubules, basophilic and dilated collecting tubule, transitional epithelial hyperplasia of the urinary bladder in both sexes. Furthermore, in the kidneys in females, scattered whitish points and enlargement, necrosis of epithelial cells in proximal tubules, inflammatory infiltration in interstitial cells, cast, hyperplasia in renal pelvic mucosa and dilatation of renal pelvis were observed (Initial Risk Assessment Report (NITE, CERI, NEDO (2005)). Moreover, in the 90-day feeding study with rats, it was reported that the only noteworthy histopathological changes were found in the liver and kidneys, and that slight to moderate hepatic cell necrosis accompanied by the marked elevation of hepatic enzymes (AST and ALT) were noted in some animals in 2000 ppm (140 mg/kg/day) group (EU-RAR (2002)). In the rat feeding study over three generations (3-generation reproductive toxicity study), degeneration or hypertrophy in renal tubules was noted in males of all generations and in females of third generation at the dose levels of 15 mg/kg/day or more, and in females of F1 and F2 generations at 160 mg/kg/day (Initial Environment Risk Assessment of Chemicals (Ministry of Environment), vol. 2 (2003)). According to the results described above, histopathological changes in the liver and kidneys were found at doses applicable to Category 2 of the guidance values or higher, thus the substance was classified as Category 2 (liver, 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 1	Warning	H400	P273 P391 P501	Classified into Category 1 from its 96h-EC50 = 0.027 mg/L for algae (Skeletonema costatum) (EU-RAR, 2002).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (EU-RAR, 2002).	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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