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

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GENERAL INFORMATION
 
Item Information
CAS RN 16672-87-0
Chemical Name Ethephon
Substance ID m-nite-16672-87-0_v2
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. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
2 Flammable gases Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Aerosols Not classified (Not applicable)
-
-
- - Not an aerosol product. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Oxidizing gases Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
5 Gases under pressure Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
6 Flammable liquids Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
7 Flammable solids Classification not possible
-
-
- - No data.
Besides, there is information that it is nonflammable (HSDB (2010)).
FY2011 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. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
10 Pyrophoric solids Not classified
-
-
- - It was classified as "Not classified" from information that it is nonflammable (HSDB (2010)). FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Self-heating substances and mixtures Not classified
-
-
- - It was classified as "Not classified" from information that it is nonflammable (HSDB (2010)). FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- - It contains a semimetal (P), but it is conceivable that it does not react vigorously with water from data on the water solubility of 1239 g/l (GESTIS (Access on May. 2011)). FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - "Solids" according to GHS definition. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
14 Oxidizing solids Classification not possible
-
-
- - An organic compound that contains chlorine and oxygen chemically bonded to P, but the classification is not possible due to no data. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
15 Organic peroxides Not classified (Not applicable)
-
-
- - An organic compound that does not contain -O-O- structure. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
16 Corrosive to metals Classification not possible
-
-
- - No established test method suitable for solid substances. FY2011 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
[Rationale for the Classification]
Based on (1) to (4), it was classified in Category 4 by adopting the category with the higher hazard. Based on the new findings, the classification result was changed.

[Evidence Data]
(1) LD50 for rats: 2,144 mg/kg (males: 2,664 mg/kg, females: 1,563 mg/kg) (OECD TG 401) (CLH Report (2011), JMPR (2015))
(2) LD50 for rats: 1,600 mg/kg (EPA pesticide RED (1995))
(3) LD50 for rats (males): 2,639 mg/kg (JMPR (2015))
(4) LD50 for rats (females): 1,564 mg/kg (JMPR (2015))

[Reference Data, etc.]
(5) This substance was classified in Category 4 in the EU CLH.
FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
[Rationale for the Classification]
Based on the data on females in (1), it was classified in Category 3. Also, based on the new findings, the classification result was changed.

[Evidence Data]
(1) LD50 for rabbits: 1,517 mg/kg (males: 1,210 mg/kg, females: 983 mg/kg) (OECD TG 402) (CLH Report (2011), JMPR (2015))

[Reference Data, etc.]
(2) This substance was classified in Category 3 in the EU CLH.
FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified."
FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1 Acute toxicity (Inhalation: Dusts and mists) Category 4


Warning
H332 P304+P340
P261
P271
P312
[Rationale for the Classification]
Based on (1), it was classified in Category 4.

[Evidence Data]
(1) LC50 (4 hours) for rats: 3.20 mg/L (OECD TG 403) (CLH Report (2011))

[Reference Data, etc.]
(2) LC50 (exposure time unknown) for rats: 3.26mg/L (OECD TG 403) (JMPR (2015), EFSA (2008), EPA pesticide RED (1995))
FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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
Because corrosive to this substance proven by spots of necrosis and edema in 4 out of 6 animals and contact erythema in 6 animals observed after an application of 0.5 mL of a water solution to rabbit skins for one to four hours was reported (JMPR 861 (1993)), and a pH about 1 of this substance was described (Sax (11th, 2004)), it was classified in Category 1. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
Because a corneal injury in a test applied to rabbit conjunctival sac was reported (HSDB (2010)), and a pH about 1 of this substance was described (Sax (11th, 2004)), it was classified in Category 1.
Besides, this substance showed corrosive in a dermal irritation test, also had a response to eyes, and was classified in "Category I" (the highest category in four categories) in EPA (EPA RED factsheet (1996)).
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Respiratory sensitization Classification not possible
-
-
- - No data. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Skin sensitization Not classified
-
-
- - Evidence of contact sensitization was not found as a result of a skin sensitization test using guinea pigs. (JMPR 861 (1993))
And EPA concluded from no provocation of skin sensitization that this substance was negative. (EPA RED (1995))
Therefore, it was classified as "Not classified."
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
5 Germ cell mutagenicity Not classified
-
-
- - From negatives in a dominant lethal test (in vivo heritable mutagenicity test using germ cells) using rats and a micronucleus test (in vivo mutagenicity test) using mice (JMPR (861 (1993)), it was classified as "Not classified."
Besides, as in vitro test results, a positive in an Ames test, a negative in a chromosomal aberration test using Chinese hamster ovary cells, and a negative in an HGPRT gene mutation test using Chinese hamster ovary cells were reported. (JMPR 861 (1993))
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
6 Carcinogenicity Not classified
-
-
- - It was reported that carcinogenicity was not observed in both two diet administration tests using rats for 104 weeks or 97 to 104 weeks. (JMPR 861 (1993))
Furthermore, it was reported that carcinogenicity was not indicated from no increase in exposure-related incidences of tumors in both two 78-week diet administration tests using mice. (JMPR 861 (1993))
Because evidence of carcinogenicity was not obtained in any of carcinogenicity tests conducted twice in 2 species of animals respectively, it was classified as "Not classified."
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a two-generation reproductive diet administration test before mating and through mating, gestation, parturition, and lactation periods in rats, reduced body weights during gestation and lactation periods in a high dose group (30000 ppm) in parent animals of the second generation, and increased stillbirths and perinatal deaths in offspring from the second generation were reported. (JMPR 861 (1993))
Furthermore, in an oral administration test in pregnant rabbits during an organogenetic period, teratogenicity was not observed but decreases in a survival rate and weight gain were indicated in maternal animals. And high ratios in post-implantation losses and early resorption, and a low mean number of live offspring at the same dose were reported. (JMPR 861 (1993))
From the above results, it was classified in Category 2.
Besides, neither sexual function and fertility including mating, coitus, and gestation in each generation in the two-generation reproduction test (EPA RED (1995)) nor adverse effects on the development of the offspring including teratogenicity in an administration test during an organogenetic period in pregnant rats (JMPR 861 (1993)) were observed.
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
8 Specific target organ toxicity - Single exposure Category 2 (nervous system)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
At 1000 to 2000 mg/kg in oral administration in rats, in addition to deaths (only in females), transient symptoms such as pupil contraction, increased urination, decreased body temperature, and reduced motor activity were observed. (JMPR 861 (1993))
On the other hand, there is information that the most sensitive exposure indicator of this substance which causes poisoning symptoms similar to ones by organophosphates such as salivation, lacrimation, urination and defecation for test animals at a high dose, is an inhibition of cholinesterase in blood cells and plasma, which occurs even at a low dose. (IRIS RED (2006))
From the above knowledge, it was classified in Category 2 (nervous system) because rats showed symptoms at doses corresponding to Category 2 in Guidance values.
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - In a 16-day or 22-day oral administration test using human volunteers, a significant inhibition of plasma cholinesterase activity was reported. (JMPR 861 (1993))
Besides, in experimental animals, in oral administration tests dosed rats for 4 weeks, mice for 4 weeks, and dogs for 2 years, a significant inhibition of plasma and red blood cell cholinesterase activity was reported. (JMPR 861 (1993))
The inhibition of cholinesterase activity in plasma and red blood cells by exposure to this substance which occurred even at a low dose is considered to be a sensitive exposure indicator. (IRIS (2006))
However, effects observed in the above human and animal tests were not accompanied by other effects such as related poisoning symptoms and pathological changes but were only changes in test values (cholinesterase activity values), therefore, it was classified as "Classification not possible."
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
10 Aspiration hazard Classification not possible
-
-
- - No data. FY2011 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 3
-
-
H402 P273
P501
It was classified in Category 3 from 96-hour EC50 = 23.5 mg/L for algae (Chlorella pyrenoidosa) (AQUIRE, 2012). FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501
If chronic toxicity data are used, then it is classified as "Not classified" from 96-hour NOEC = 2 mg/L for algae (Chlorella pyrenoidosa) (AQUIRE, 2012), despite a lack of rapid degradability (BIOWIN).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 from a lack of rapid degradability (BIOWIN), and 48-hour EC50 = 31.7 mg/L for crustacea (Daphnia magna) (AQUIRE, 2012).
It was classified in Category 3 by drawing a comparision between the above results.
FY2011 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. FY2011 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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