GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 107-07-3 |
| Chemical Name | Ethylene chlorohydrin |
| Substance ID | H29-B-018 |
| Classification year (FY) | FY2017 |
| 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) | |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| 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 |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Category 3 |
 Warning |
H226 |
P303+P361+P353
P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Based on a flash point of 60 deg C (closed cup) (ICSC (J) (2003)), it was classified in Category 3. Besides, it is classified in Division 6.1, Subsidiary Risk 3, PG I in UNRTDG (UN 1135). |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 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 classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 425 deg C (ICSC (J) (2003)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid 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 |
- |
- | - | It is an organic compound does not contain fluorine but contains oxygen and chlorine, amd the oxygen and chlorine are not chemically bonded to elements other than carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 3 |
 Danger |
H301 |
P301+P310
P264 P270 P321 P330 P405 P501 |
There are five reports of LD50 values of 71 mg/kg (PATTY (6th, 2012)), 71.3 mg/kg (DFGOT Vol. 5 (1993), PATTY (6th, 2012)), 72 mg/kg (ACGIH (7th, 2001), PATTY (6th, 2012)), 77 mg/kg (DFGOT Vol. 5 (1993)), and 95 mg/kg (PATTY (6th, 2012)) for rats. Based on these, it was classified in Category 3. |
| 1 | Acute toxicity (Dermal) | Category 2 |
Danger |
H310 |
P302+P352
P361+P364 P262 P264 P270 P280 P310 P321 P405 P501 |
Based on reported LD50 values of 68 mg/kg for rabbits (PATTY (6th, 2012)), 84 mg/kg for rats (PATTY (6th, 2012)), and 70 mg/kg for guinea pigs (PATTY (6th, 2012)), it was classified in Category 2. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 1 |
Danger |
H330 |
P304+P340
P403+P233 P260 P271 P284 P310 P320 P405 P501 |
Based on a 4-hour inhalation LC50 value of 33 ppm for rats (PATTY (6th, 2012)), it was classified in Category 1. Besides, since the LC50 value is lower than 90% of the saturated vapor pressure concentration (6,436 ppm), a reference value in the unit of ppm was applied as vapour with little mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | Based on reports that in skin irritation tests with rabbits, slight erythema was observed, and no significant irritation was observed (NTP TR275 (1985), DFGOT Vol. 5 (1993), PATTY (6th, 2012)), it was classified as "Not classified" (Category 3 in UN GHS classification). |
| 3 | Serious eye damage/eye irritation | Category 2A |
 Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
Based on reports that eye irritation was observed in workers handling this substance (AGCIH (7th, 2001)), and that moderate eye irritation was observed in eye irritation tests with rabbits (PATTY (6th, 2012), DFGOT Vol. 5 (1993), NTP TR275 (1985)), it was classified in Category 2A. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Although there is a description that it was not sensitizing in a skin sensitization test with guinea pigs (PATTY (6th, 2012), NTP TR275 (1985)), it was classified as "Classification not possible" because test conditions and reaction rate, etc. are unknown. Besides, because IUCLID (2000) which was the evidence for the previous classification was not available and could not be confirmed, it was not used. Therefore, the classification result was changed from the previous one. |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, a dominant lethal test and a reciprocal translocation test with mice, micronucleus tests with mouse bone marrow cells or peripheral blood, and a chromosome aberration test and a sister chromatid exchange test with mouse bone marrow cells were all negative, and a chromosome aberration test with rat bone marrow cells was positive (ACGIH (7th, 2001), DFGOT Vol. 5 (1993), PATTY (6th, 2012), NTP DB (Access on May 2017)). As for in vitro, bacterial reverse mutation tests, and a mouse lymphoma test, a chromosome aberration test and a sister chromatid exchange test with mammalian cultured cells were all positive (ACGIH (7th, 2001), DFGOT Vol. 5 (1993), PATTY (6th, 2012), NTP DB (Access on May 2017)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - |
In an epidemiological study of 278 male workers assigned for 2 years or more in a production section for this substance (chlorohydrin section) of company A, six deaths due to pancreatic cancer (expected value 0.7) and three deaths due to leukemia (expected value 0.4) are reported. Statistically significant trends between duration of assignment to the chlorohydrin section and both diseases were observed. In chlorohydrin production, this substance is primarily produced from ethylene and chlorine, and ethylene dichloride (1,2-dichloroethane) and bischloroethyl ether are produced as by-products. In the follow-up survey after ten years, two cases of pancreatic cancer were added, the total deaths due to pancreatic cancer became 8 cases (expected value 1.6) and a standard mortality ratio (SMR) became 492. There were no additional deaths due to leukemia, but 8 cases from lymphopoietic and hematopoietic cancers (expected value 2.7, SMR=294) were observed. Most of the cases were the workers who were first assigned to this section in the 1930s, when manufacturing was in its infancy and the control over exposure was not enough. From the viewpoint of industrial hygiene, it is suggested that a part of the deaths due to pancreatic cancer may come from accidental overexposures to ethylene dichloride, perhaps in combination with other chlorinated hydrocarbons. On the other hand, in the study of 1,361 workers assigned to the manufacturing processes of ethylenechlorohydrin and propylenechlorohydrin in company B, no increased risk of pancreatic cancer and lymphopoietic and hematopoietic cancer was seen. As the difference between them, differences in the process of producing ethylene oxide from this substance were pointed out (PATTY (6th, 2012)). As in the above, there are contradictory reports as epidemiological studies, and it cannot be stated that there is sufficient evidence indicating that this substance is carcinogenic in humans. As for experimental animals, in a 2-year carcinogenicity test with rats and mice dosed dermally, in a 70-week test with mice dosed subcutaneously, and in a 2-year test with rats dosed by drinking water, no evidence of carcinogenicity was shown in any (NTP TR275 (1985), PATTY (6th, 2012)). However, there is a report that in a test in which rats were subcutaneously dosed (2 times/week) for one year and were observed after six months, an increased incidence of pituitary gland adenomas was observed (PATTY (6th, 2012)). As for classification results by other organizations, only ACGIH classified it in A4 (ACGIH (7th, 2001)). From the above, although there are reports that in epidemiological studies in humans, an increase of pancreatic cancer, lymphopoietic and hematopoietic cancers were observed, there are also negative reports, and many animal tests were negative. Therefore it was classified as "Classification not possible" for this hazard class. Besides, in the previous classification, it was classified in Category 1 based on the epidemiological data from the information source of PATTY (previous edition); however, as described above, there are contradictory reports of carcinogenicity with this substance, and it is highly possible that in the report that it is carcinogenic, the effects were not by exposure of this substance alone but by a combined exposure. Therefore, the classification result was changed. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
As a result of administration by gavage during the organogenesis period (gestational day 6-15) to pregnant mice, only low values of body weight and liver weight in fetuses were observed at 100 mg/kg/day where a decreased body weight was observed in maternal animals. In addition, in a test with pregnant mice dosed by drinking water during an organogenesis period, no effects were observed in either maternal animals or fetuses at doses up to 200 mg/kg/day (DFGOT Vol. 5 (1993), PATTY (6th, 2012)). On the other hand, in an intravenous administration test with pregnant rats, embryotoxicity/foetotoxicity (gestational day 4-6, and gestational day 10-12) or teratogenicity (gestational day 8-10) were observed in fetuses at a dose (120 mg/kg/day) where deaths and decreased body weight gain were observed in maternal animals. However, in an intravenous administration test with pregnant rabbits (gestational day 6-14, maximum 36 mg/kg/day), no effects were observed in either maternal animals or fetuses (DFGOT Vol. 5 (1993), PATTY (6th, 2012)). From the above, in developmental toxicity tests with pregnant animals dosed orally or intravenously, there was no or minor developmental effects other than fetal toxicity or teratogenicity at the maternal toxic doses in the intravenous administration to mice. Therefore, it was judged that this substance is unlikely to show developmental toxicity. However, there is no information on the effect of this substance on fertility and sexual function, so it was classified as "Classification not possible" due to lack of data for this hazard class. Besides, in the previous classification, it was classified in Category 2 based on the effects observed in fetuses. It was thought that these were the effects observed in the intravenous administration test with pregnant mice. However, as described above, in any of the intravenous administration test with rabbits and the two oral administration tests with mice, no findings supporting the evidence for the previous classification were found in the fetuses, and it was considered that developmental toxicity was due to a secondary effect of maternal toxicity. Therefore, it was not adopted. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, cardiovascular system, respiratory organs), Category 3 (narcotic effects) |
Danger Warning |
H370
H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
As for humans, multiple cases were reported that in acute inhalation of this substance, headaches, dizziness, burning in the eyes, nausea, vomiting and numbness in the hands and fingers occurred in early times, and subsequently confusion, dyspnea, unconsciousness and circulatory collapse occurred, and deaths due to cardiocirculatory failure and pulmonary oedema occurred (DFGOT Vol. 5 (1993), PATTY (6th, 2012)). As a result of autopsy, there were reports that hyperaemia of the multiple organs, cerebral oedema, pulmonary oedema, fatty change in the liver and myocardium, and swelling of the kidneys were observed (DFGOT Vol. 5 (1993), PATTY (6th, 2012)). In addition, two fatal cases due to accidental ingestion were reported, and there is a description that the symptoms were similar to those seen in the inhalation exposure cases (DFGOT Vol. 5 (1993)). Moreover, there is a description that this substance is irritating to the upper respiratory tract (HSDB (Access on June 2017)). From the above, it is considered that this substance affects the central nervous system, cardiovascular system, and respiratory organs, and it shows narcotic effects. Therefore, it was classified in Category 1 (central nervous system, cardiovascular system, respiratory organs), Category 3 (narcotic effects). In the previous classification, the haemal system, kidneys, and liver were also adopted as target organs, but the details of these organs were unknown, so the classification result was revised. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (pancreas, systemic toxicity) |
Warning |
H373 |
P260
P314 P501 |
No information on humans is available. As for experimental animals, in a 90-day repeated oral dose toxicity test with rats dosed by gavage, growth retardation and deaths were observed at 67.5 mg/kg/day within the guidance value range for Category 2 (PATTY (6th, 2012), DFGOT Vol. 5 (1993), ACGIH (7th, 2001)), in a 220-day repeated dose toxicity test with rats dosed by feeding, growth retardation was observed at or above 0.12% (converted guidance value: 60 mg/kg/day) within the guidance value range for Category 2, and an increase in mortality rate was observed at 0.24% (converted guidance value: 120 mg/kg/day) exceeding the guidance value range for Category 2 (PATTY (6th, 2012), DFGOT Vol. 5 (1993)). In addition, it is reported that in a 13-week dermal application test with rats and mice, in rats, pancreatic acinar cell vacuolar change was observed at or above 125 mg/kg/day within the guidance value range for Category 2, deaths were observed at or above 250 mg/kg/day exceeding the guidance value range for Category 2, and in the case of animals which died or were sacrificed in extremis, pulmonary congestion or edema was observed, in mice, at doses exceeding the guidance value range for Category 2, death, acute nephrosis, hepatocellular fatty changes, pancreatic acinar cell necrosis were reported (NTP TR275 (1985)). Other than these, there is a report that in a 4-month inhalation toxicity test (4 hours/day) with rats, decreased body weights, histopathological effects on the liver and lungs, and an effect on the nervous system were observed at or above 0.31 ppm (converted guidance value: 0.0007 mg/L) within the guidance value range for Category 1, but the details were unknown (PATTY (6th, 2012)). From the above, because the target organ other than the pancreas could not be identified and deaths were observed, therefore, it was classified in Category 2 (pancreas, systemic toxicity). Besides, although RTECS was used in the previous classification, it was not used this time because of the information source in List 3. Moreover, the classification was revised because of using the new information sources. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 |
P273
P501 |
From 96-hour LC50 = 19.1 mg/L for fish (Carassius auratus) (ECETOC TR91: 2003), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Due to being rapidly degradable (readily biodegradable, a degradation rate by BOD: 50%, 87% (10 days) (NLM HSDB: 2005)), no bioaccumulation (BCF = 0.62 (NLM HSDB: 2005)), and 38-day NOEC (survival rate) = 8.89 mg/L for fish (Oryzias latipes) (ECETOC TR91: 2003), it was classified as "Not classified." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |