GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 88-85-7
Chemical Name 2-(1-Methylpropyl)-4,6-dinitrophenol [Dinoseb]
Substance ID H28-B-06-METI, M-005B
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 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 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.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- -  Solid (GHS definition).
3 Aerosols Not applicable
-
-
- -  Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- -  Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- -  Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- -  Solid (GHS definition).
7 Flammable solids Classification not possible
-
-
- -  No data available. Besides, there is the information that it is combustible (ICSC (2011)).
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.
9 Pyrophoric liquids Not applicable
-
-
- -  Solid (GHS definition).
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.
11 Self-heating substances and mixtures Classification not possible
-
-
- -  Test methods applicable to solid (melting point <= 140 deg C) 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
-
-
- -  Solid (GHS definition).
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.
15 Organic peroxides Not applicable
-
-
- -  Organic compounds containing no bivalent -O-O- structure in the molecule
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)).

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
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.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
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.
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.
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)).
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
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)).
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.
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.
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.
9 Specific target organ toxicity - Repeated exposure Category 1 (genetic 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.
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 LC50 = 0.058 mg/L for fish (Ictalurus punctatus) (SIDS, 2008), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) 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.
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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