NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	88-85-7
Chemical Name	2-(1-Methylpropyl)-4,6-dinitrophenol [Dinoseb]
Substance ID	m-nite-88-85-7_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	- -	-	-	There is a nitro group as a chemical group associated with explosive properties present in the molecule, and the calculated oxygen balance is -140. However, because it is classified in Division 6.1 (Poisonous Material), PG I (UN2779) in UNRTDG, it is estimated that it does not correspond to explosives which is hazard class with the highest precedence.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is the information that it is combustible (ICSC (2011)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a nitro group as a chemical group associated with explosive properties present in the molecule. However, because it is classified in Division 6.1 (Poisonous Material), PG I (UN2779) in UNRTDG, and it does not correspond to self-reactive substances and mixtures which is hazard class with the highest precedence, it was classified in Type G.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	Because it is classified in Division 6.1 (Poisonous Material), PG I (UN2779) in UNRTDG, it is estimated that it does not correspond to pyrophoric solids which is hazard class with the highest precedence.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (N), but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	It is a substance with a melting point of 55 deg C or lower, but the classification is not possible due to no data. Besides, there is the information that "it is corrosive to mild steel in the presence of water" (HSDB (Access on October 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	As for an LD50 value for rats, based on the information "it was estimated to be between 5 mg/kg and 50 mg/kg" (JECDB (Access on October 2016), SIDS (2008)), this substance was classified in Category 2. 　Besides, since Chemical Substance Hazard Data (CERI, 1988) used in the previous classification is the information source listed as List 3, this information was not adopted as the evidence of classification.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 1	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	There are 2 reports that LD50 values for rabbits are 40 mg/kg (males and females), 146 mg/kg (males and females) (SIDS (2008)). One data corresponds to Category 1, and the other corresponding to Category 2. It was classified in Category 1 by adopting a more hazardous category. The classification was revised based on the new information. 　Besides, since Chemical Substance Hazard Data (CERI, 1988) used in the previous classification is the information source listed as List 3, this information was not adopted as the evidence of classification.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Category 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	There are 2 reports that LC50 values (4 hours) for rats are between 33 mg/m3 and 290 mg/kg (SIDS (2008)) and between 35 mg/m3 and 130 mg/m3 (SIDS (2008)), and they correspond to Category 1 - Category 2. It was classified in Category 1 by adopting a more hazardous category. The category was revised based on the new information.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　The category was changed due to the revision of the GHS classification guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It is reported that because in an eye irritation test using rabbits, as a result of applying this substance (51 - 55%), corneal opacity and irritation of the conjunctiva were observed until 7 days after application, this substance was highly irritating to the eye 　 (SIDS (2008)). From the above, this substance was classified in Category 2A. 　Besides, this substance was classified as "Eye Irrit. 2 H319" in EU CLP classification (ECHA C&L Inventory (Access on June 2015)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　There was no in vivo data. 　As for in vitro, a bacterial reverse mutation test and a mammalian cell chromosomal aberration test were negative (SIDS (2008), JECDB (Access on October 2016), IRIS summary (1989)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	In a 2-year carcinogenicity study using mice dosed by feeding, it was showed that the incidence of liver adenomas significantly increased. However, because the reanalysis failed to observe an increased trend, and changes observed before developing hepatocellular carcinomas such as hyperplasia and degeneration were not observed in the liver, EPA judged that the increase in liver adenoma is not the effects of administration of the test substance, therefore, it was classified as Group D (IRIS Summary (1989)). 　On the other hand, Office of Pesticide Programs (OPP) in the EPA classified this substance as Group C (Possible Human Carcinogen) (EPA OPP Chemicals Evaluated for Carcinogenic Potential (2015 (year of classification: 1986)). 　Thus, although the classification results differ between IRIS and OPP, the substance was classified as "Classification not possible" for this hazard class by adopting the classification result of EPA IRIS which classification year is more recent.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) using rats dosed by gavage, 10 out of 12 in females died or were sacrificed in extremis on 19-21 days of gestation in the high dose group (7 mg/kg/day). In the surviving females, suppressed body weight gain was observed, but no severe toxicity was observed in males. As for reproductive effects, a decrease in sperm viability and motility, an increase in the abnormal sperm rate in paternal animals, and a decreased gestation index in maternal animals were observed (SIDS (2008), Environmental Risk Assessment for Chemical Substances vol.7 (Ministry of the Environment, 2009)). 　In addition, in a one-generation test in which male rats were dosed by feeding for 77 days and then mated with untreated females, at 15.6 mg/kg/day or more, deaths in males (15.6 mg/kg/day: 1 out of 20, 22.2 mg/kg/day: 10 out of 36) and toxic symptoms including fever, weakness and irregular breathing were observed, at 9.1 mg/kg/day or more, decreased sperm counts and increased abnormal sperm rate, and at 15.6 mg/kg/day or more, decrease in sperm motility and gestation index (increase in infertile females) were observed (SIDS (2008), Environmental Risk Assessment for Chemical Substances vol.7 (Ministry of the Environment, 2009)). 　On the other hand, in a developmental toxicity study using pregnant rats given this substance by oral (feeding) administration on 6-15 days of gestation, microphthalmia in addition to lowered body weight and skeletal variations in fetuses were observed at the dose (200 ppm) where reduced body weight gain was observed in maternal animals (SIDS (2008)). 　Moreover, also in a study using pregnant rabbits given this substance by dermal application on 7-19 days of gestation, an increased incidence of hydrocephaly and anophthalmia was observed in fetuses at the dose of 3 mg/kg/day or more where maternal animals toxicity (death, fever) was observed (SIDS (2008)). 　From the above, the reproductive effects including the effects on sperm, a decreased gestation index and an increased incidence of external malformations in fetuses were observed at the doses where severe toxicity findings such as deaths were observed in the parental animals, therefore, the substance was classified in Category 2 for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, liver), Category 2 (kidney), Category 3 (narcotic effects)	Danger Warning	H370 H371 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	It is described that in humans, this substance exerts direct actions on the cerebrum and lower brain centers consisting of stimulation followed by depression, that it may also produce a necrotizing tubular injury of the kidneys, and that in the case of fulminating type of poisoning, people die within 24 hours, and the cause of death is respiratory and circulatory collapse (HSDB (Access on October 2016). As for case reports, the case is reported that a farmer who was exposed by inhalation and had his/her hands exposed due to malfunction of the equipment during spraying of the herbicide containing this substance developed fever, tremors, dyspnea, a sudden cough, rales, Kernig's signs, jaundice in the skin and the sclera of the eyes, a decrease in liver and lung function, and lethargy but recovered after about 12 weeks (Environmental Risk Assessment for Chemical Substances vol.7 (Ministry of the Environment, 2009)). In addition, it is reported that an infant who accidentally ingested a liquid containing this substance as a main ingredient died of heart paralysis after showing unconsciousness, convulsions and high fever, and that at necropsy, yellow discoloration of the hands, meninges, respiratory tract, esophagus and stomach mucosa were observed, and that in the histological findings of liver, cells containing glycogen-containing nuclear inclusions suggesting damage of cells in the perilobular region of the liver were observed (Environmental Risk Assessment for Chemical Substances vol.7 (Ministry of the Environment, 2009)). 　As for experimental animals, in a 4-hour single inhalation exposure study using rats, labored breathing and decreased activity were observed at 0.033 mg/L, which is equivalent to Category 1 (SIDS (2008)). In addition, in a single oral dose test using rats, a prone position, bradypnea, diarrhea, and a decrease in locomotor activity were observed at 50 mg/kg, which is equivalent to Category 1 (JECDB (Access on October 2016)). 　From the above, it is thought that this substance shows effects on the central nervous system, respiratory organs, cardiovascular system, liver, and kidney. Of these, since the effects on respiratory organs and cardiovascular system are thought to be the secondary effects of action on the central nervous system, these organs were excluded from the target organs. Therefore, it was classified in Category 1 (central nervous system, liver), Category 2 (kidney), Category 3 (narcotic effects). Since HSDB is the information source listed in List 2, it was classified in Category 2 for the kidney. Since new information source was used, the category was changed from the previous classification.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (reproductive organs, eye)	Danger	H372	P260 P264 P270 P314 P501	There is no useful information on humans. 　As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test using rats dosed by gavage, at 0.78 mg/kg/day (converted guidance value: 0.36 mg/kg/day), which corresponds to Category 1, or higher, an increase or an increased trend in red blood cell counts and the hematocrit level, and at 2.33 mg/kg/day (converted guidance value: 1.09 mg/kg/day) or higher, an increase in the hemoglobin content, a decrease in extramedullary hematopoiesis in the spleen, etc. were observed, and at 7.0 mg/kg/day (converted guidance value: 3.27 mg/kg/day), an increase in mean corpuscular volume, a decrease in sperm motility, a decrease in a sperm survival rate, and an increase in a malformed sperm rate, etc. were reported (JECDB (Access on October 2016), SIDS (2008), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009). In a 13-week repeated dose toxicity study using rats dosed by feeding, at 0.004% (converted guidance value described in the original article: male: 3.49 mg/kg/day, female: 3.76 mg/kg/day), which is equivalent to Category 1, or higher, an increase in red blood cell counts, hemoglobin levels, and hematocrit values, at 0.012% (converted guidance value described in the original article: male: 11.95 mg/kg/day, female: 11.97 mg/kg/day) or higher, an increase in relative weights of the heart, kidney, and spleen, a decrease in specific gravity of urine, and at 0.036% (converted guidance value described in the original paper: male: 56.8 mg/kg/day, female: 52.8 mg/kg/day), deaths (13 out of 20 in 1 week, surviving animals were slaughtered due to moribundity after 6 week), suppressed body weight gain, aplasia of the lymphoreticular tissue, and an increase in blood urea nitrogen were observed. In a 12-month repeated dose toxicity study using rats dosed by feeding, depletion of the glycogen in the liver, a minor increase in iron deposition in the liver and kidney, an increase in the amount of blood urea nitrogen and the tendency of hemoconcentration were reported at 0.004% (converted guidance value described in the original article: male: 2.46 mg/kg/day, female: 3.28 mg/kg/day), which is equivalent to Category 1, or higher (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)). Moreover, in a 2-year carcinogenicity study using mice dosed by feeding, at 1 mg/kg/day, which is equivalent to Category 1, or higher, cystic endometrial hyperplasia and testicular atrophy or degeneration with hypospermatogenesis (IRIS (1987), SIDS (2008)), and at 3 mg/kg/day or higher (low-dose animals not examined), lenticular opacities were reported (IRIS (1987)). 　Of the described above, with respect to the increase in red blood cells, it is thought that dinitrophenols have an effect of increasing oxygen consumption, resulting in a decrease in arterial blood oxygen saturation and an increase in erythropoietin, leading to an increase in red blood cell production (JECDB (Access on October 2016)). 　From the above, this substance was classified in Category 1 (genetic organs, eye). 　Besides, as for the description in the previous classification that "it has toxic effects on the liver, kidneys and nervous system, and produces degenerative changes in the hepatic parenchyma and renal tubules," it was a description on aromatic nitro compounds in general.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 96-hour LC50 = 0.058 mg/L for fish (Ictalurus punctatus) (SIDS, 2008), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	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, 2004)), its 10-day NOEC for fish (Salvelinus namaycush) is < 0.0005 mg/L , and its 10-day NOEC for fish (Oncorhynchus clarkii) is < 0.0005 mg/L (both SIDS, 2008), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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