GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 13356-08-6
Chemical Name Fenbutatin oxide
Substance ID H28-B-046, C-073B
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
-
-
- -  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.
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 applicable
-
-
- -  Solid (GHS definition).
10 Pyrophoric solids Classification not possible
-
-
- -  No data available.
11 Self-heating substances and mixtures Classification not possible
-
-
- -  No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- -  It is estimated that it does not react vigorously with water due to the water solubility result of 0.0127 mg/L measured (HSDB (Access on June 2016)).
13 Oxidizing liquids Not applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- -  It is an organic compound containing oxygen (but not fluorine or chlorine), 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
-
-
- -  Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- -  On the basis of 2 reported LD50 values of 2,631 mg/kg (JMPR (1977)), 4,400 mg/kg (EPA RED (1994), JMPR (1992)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification). The category was revised due to the revision of the GHS classification guidance for the Japanese Government.
1 Acute toxicity (Dermal) Not classified
-
-
- -  On the basis of a reported LD50 value of > 2,000 mg/kg (EPA RED (1994)) for rabbits, it was classified as "Not classified."
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 2


Danger
H330 P304+P340
P403+P233
P260
P271
P284
P310
P320
P405
P501
 On the basis of 3 reported LC50 values (4 hours) of 0.072-0.074 mg/L (JMPR (1992), EPA RED (1994)), 0.14, 0.23 mg/L (JMPR (1992)) for rats, it was classified in Category 2. The category was revised due to the revision of the GHS classification guidance for the Japanese Government.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
 It is reported that in a skin irritation test in rabbits, it was mildly irritating (EPA RED (1994)), and in a skin irritation test using experimental animals (described as mammals, but species is unknown) it was irritating (HSDB (Access on June 2016)). Therefore, it was classified in Category 2.
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
 It is reported that in an eye irritation test in rabbits, it was severely irritating (EPA RED (1994)), and in an eye irritation test using experimental animals (described as mammals, but species is unknown) it was severely irritating (HSDB (Access on June 2016)). It was classified in Category 2A because irreversible lesions are not described.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  It is reported that a skin sensitization test using guinea pigs (Buehler test) was negative (EPA RED (1994)), but there is only one datum of negative. Therefore, it was classified as "Classification not possible."
5 Germ cell mutagenicity 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, it was classified as "Classification not possible." As for in vivo, a micronucleus test using bone marrow cells of mice was negative (EPA RED (1994), JMPR (1992)). As for in vitro, bacterial reverse mutation tests were negative, and for cultured mammalian cell tests, gene mutation tests were negative and a chromosome aberration test was negative (EPA RED (1994), JMPR (1992)).
6 Carcinogenicity Classification not possible
-
-
- -  In carcinogenicity tests in which this substance was administered by feeding to rats for two years and mice for 18 months, a dose-related increase in tumors was not observed (JMPR (1992)). As the classification by other organizations, ACGIH classified organic tin compounds as A4 (ACGIH (7th, 2001)). 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 two and three generation reproductive toxicity studies (2 litters/maternal animal of each generation) with diet administration to rats, in a two generation study, even administering to parental animals until general toxicity expression occurred (reduced weight gain, decreased food consumption), no effect on fertility in parental animials and only slight effects in offspring (lower body weights by weaning) were observed. However, in a three generation study, in the high-dose group (300 ppm), along with general toxicity effects (lower body weights, hyperactivity, and irritability), reduced litter size was found in F1b maternal animals as reproductive effects, and decreased survival rate in F3a and F3b offspring during nursing and the decreased relative testicular weights in the F3b male pups were observed as developmental effects in next generation (JMPR (1992)). On the other hand, in development toxicity tests by gavage administration to pregnant rats or pregnancy rabbits during organogenesis period, at the dose where maternal toxicity (rats: reduced body weight gain, diarrhea; rabbits: decreased body weights, anorexia, abortion) were found, embryo/fetus toxicity such as increase in pre-implantation loss in rats, increase in post-implantation loss and increase in litters with no live offspring in rabbits was observed (JMPR (1992)). As above, it was classified in Category 2 for this hazard class because reproductive/developmental toxicity was observed at dose where general toxicity occurred in parent animals.
 Besides, the Category was assigned at this time because information of newer year than the information used in the previous classification.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory organs, kidney)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
 There is no data of a single exposure to this substance in humans. As for experimental animals, it is reported that in a single inhalation exposure test using rats, necrosis of bronchiolar epithelium, lung congestion and edema, and lesions in renal tubule epithelium were observed at a dose within a guidance value range of Category 1 (JMPR (1992)). Form the above, it was classified in Category 1 (respiratory organs, kidney). Besides, in the previous classification, the liver and testis were adopted as target organs on the basis of the report that massive fatty changes in the liver and reduced spermatogenesis were observed in a single oral exposure test using rabbits (JMPR (1977)), but as for effects on the testis, it is reported that effects were not found in a follow-up experiment which added control groups (JMPR (1992)). As for effects on the liver, detailed information such as a number of animals, whether necropsy result is that of dead animal or survival animal are unknown. From the above reasons, the classification was revised.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  There is no information in humans.
 As for experimental animals, 3-month or 2-year repeated dose toxicity studies using rats dosed by feeding, 5-week or 2-year repeated dose toxicity studies using dogs dosed by gavage, a 21-day repeated dose toxicity study using rabbits dermally applied, and so on were carried out. However, no finding to be available for the evidence for GHS classification was observed in any of the studies (JMPR (1992)).
 Therefore, it was classified as "Classification not possible" due to lack of data.
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 24-hour LC50 = 0.0008 mg/L for crustacea (Daphnia magna) (ECETOC TR91, 2003), 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 (BIOWIN), and NOEC (unknown time) = 0.31-0.61 ppb for fish (Oncorhynchus mykiss) (U.S.EPA: RED, 1994), 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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