GHS Classification Result (Revision of the past classification result)

Chemical Name:Ethane, 1,1,2,2-tetrachloro-
CAS:79-34-5

Result:
ID: 22B4514
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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 4 - Warning H227: Combustible liquid P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Since its flash point 62 degC (Lange (16th, 2005)) is >= 60 degC and <= 93 degC, the substance is classified into Category 4. As relevant notes, it is reported that the substance is not combustible (Merck (13th, 2001), Chapman (2005), Hommel (1991), Weiss (2nd, 1985)), therefore it is considered that the substance has no sustained combustibility.
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 - - - - Not combustible (Merck (13th, 2001), Chapman (2005), Hommel (1991), Weiss (2nd, 1985)). As relevant notes, although its flash point 62 degC is reported (Lange (16th, 2005)), it is considered not to sustain combustion.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Not classified - - - - Not combustible (Merck (13th, 2001), Chapman (2005), Hommel (1991), Weiss (2nd, 1985)). As relevant notes, although its flash point 62 degC is reported (Lange (16th, 2005)), it is considered not to sustain combustion.
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 - - - - The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon.
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. As relevant notes, it is reported that "aluminum is unsuitable as a container, and steel is durable" (Hommel (1991)).

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Eight LD50 values for rats of 800 mg/kg, 250 - 430 mg/kg, 570 mg/kg (all from SIDS (Access on Jun. 2009)), 250 mg/kg, 330 mg/kg (both from ATSDR (2008)), 319 mg/kg (ACGIH (2001)), 1000 mg/kg (CICAD 3 (1998)) and 200 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 4 (2005)) were reported. Two of them corresponded to Category 3, one of them corresponded to Category 3 or Category 4, and five of them corresponded to Category 4. The substance was classified as Category 4 since the majority of obtaining data corresponded to it.
1 Acute toxicity (Dermal) Not classified - - - - Four LD50 values for rabbits of 3990 mg/kg, 6400 mg/kg (both from SIDS (Access on Jun. 2009)), 4000 mg/kg (PATTY, 5th (2001)) and 6300 mg/kg (ACGIH (2001))) were reported. All of them corresponded to "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" in the UN-GHS classification).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 3 Danger H331: Toxic if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
Both LC50 values for rats of 1000 ppm/4hrs (ACGIH (2001)) and 1200 ppm/4hrs (SIDS (Access on Jun. 2009)) corresponded to Category 3. The LC50 value was lower than 90% of the saturated vapor pressure concentration (approximately 6000 ppm), the criterion values of gas were adopted for the classification.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
In the rabbit test, open application of 0.01 mL of undiluted substance for 24 hours caused high irritation with the primary skin irritation index value of 6 (maximum value was 8) (SIDS (Access on Jun. 2009)). In the other rabbit test, application of the substance caused hyperemia, edema, and severe blister formation (ATSDR (1996)). It was also reported that only erythema was noted and the primary skin irritation index value was 2.6 (maximum value was 8), and the substance was evaluated as moderate irritant (IUCLID (2000)). Based on the information, the substance was classified as Category 2.
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
In the rabbit study, instillation of 0.1 mL of undiluted substance caused irritation and eye irritation index value was 42.5 (maximum value was 110)(SIDS (Access on Jun. 2009)). It was reported that exposure to vapors caused eye irritation for both human and guinea pig (CICAD 3 (1998), ATSDR (1996)). Based on the information, the substance was classified as Category 2A.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Classification not possible - - - - As for in vivo tests, negative results in the dominant lethal test using rats by inhalation exposure (SIDS (Access on Jun. 2009)), negative results in the UDS test using liver of mice orally administered (SIDS (Access on Jun. 2009)) and positive results in the somatic cell DNA binding assay using rats and mice (IARC 71 (1999)), were reported. Positive results were indicated in the micronucleus test using peripheral blood obtained from mice by the 14-week dietary administration (NTP TOX-49 (2004)). The positive data described above were not sufficient to make a decision of Category 2 in this hazard class based on the weight-of-evidence by the expert judgment, and similar opinion was also mentioned in ATSDR (ATSDR (2008)). Therefore, the substance was classified as "Classification not possible". As relevant information, as for in vitro studies, negative and positive results in the Ames test, negative results in the chromosome aberration test using CHO cells (SIDS (Access on Jun. 2009)) and gene mutation test using mouse lymphoma L5178Y cell (NTP TOX 49 (2004)), and negative and positive results in the transformation test using BALB/c3T3 cell (ACGIH (2001)), were reported.
6 Carcinogenicity Classification not possible - - - - The substance was classified as "Classification not possible" based on the criterion of "Group 3" in the carcinogenicity assessment of the IARC (IARC 71 (1999)). As relevant information, the 78-week oral administration tests using rats and mice were reported (NTP TR 27 (1978)). The statistically significant neoplastic lesions were not found in rats of both sexes in the examination after the lapse of 32 weeks of observation period following the termination of administration. The highly significant and dose-dependent incidences of hepatocellular carcinomas were showed in mice of both sexes in the examination at the terminal of administration and at after a subsequent lapse of 12 weeks.
7 Reproductive toxicity Classification not possible - - - - In the one generation study in rats that males inhaled for nine months and mated with untreated females (SIDS (Access on Jun. 2009)), no statistically significant difference between the treated groups and control group with respect to the evaluation target such as pregnancy indices and the offspring indices, and no external congenital malformation was observed. In the developmental studies by the oral administration during the organogenetic period (gestation day 6 - 15) in rats or mice (SIDS (Access on Jun. 2009)), total resorptions were observed, however, this finding was observed only at the high dose level that severe toxic effects including maternal deaths were observed. Therefore, it was not adopted for the classification. In addition to the study mentioned above, standard reproductive and developmental toxicity studies for this substance have not been carried out. Therefore, it was described that it was not possible to draw valid assessment from these limited data on reproductive/developmental toxicity (SIDS (Access on Jun. 2009), and it was also described that no conclusion on the reproductive or developmental toxicity of this substance could be drawn from these limited data (NTP TOX49 (2004)). Therefore, the substance was classified as "Classification not possible" due to lack of sufficient data.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, liver), Category 3 (narcotic effects, respiratory tract irritation) Danger
Warning
H370: Causes damage to organs (central nervous system, liver)
H335: May cause respiratory irritation (narcotic effects, respiratory tract irritation)
H336: May cause drowsiness or dizziness (narcotic effects, respiratory tract irritation)
P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
It was described that many cases of acute intoxications by the substance were fatal and that the target organs were central nervous system and the liver (HSDB (2005)). In fact, all of the eight persons who ingested 3 mL of the substance by mistake revealed coma within 1.5 - 2.5 hours, then they lost the reflexes and their pulse was barely perceptible (PATTY, 5th (2001)). In the other report, it was described that as the effects on humans who were exposed to vapors of the substance by inhalation at higher concentrations or who ingested by mistake, the signs containing tremor, headache, paralysis, lethargy, dizziness, unconsciousness were reported (SIDS (Access on Jun. 2009)). While, hepatic effects and deaths were reported following accidental poisoning with the substance. And as the human toxic findings in the early phase after exposure, in addition to unconsciousness, neurological distress, tremors, dizziness and numbness, jaundice and enlargement or degeneration of the liver were reported (CICAD 3 (1998)). In necropsy of the other acute poisoning cases, acute liver dystrophy or, as a later stage, cirrhosis were proved (BUA 29 (1989)). Based on the information on humans as described above, the substance was classified as Category 1 (central nervous system, liver). Furthermore, in addition to presence of the cases who recovered with no aftereffects from the symptoms of depressive effects on central nervous system such as dizziness, lethargy, coma, loss of reflexes, etc. (PATTY, 5th (2001)), there was information describing that narcosis was found in multiple inhalation studies in mice, guinea pigs or cats (ACGIH (2001)), and that mucosal irritation and respiratory failure were reported in workers or volunteers exposed by inhalation (CICAD 3 (1998)). Thus, the substance was additionally classified as Category 3 (narcotic effects, respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system, liver) Danger H372: Cause damage to organs through prolonged or repeated exposure (central nervous system, liver) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
It was described that increase in the prevalence of nervous symptoms containing tremors, headaches and vertigo was noted in 380 workers exposed with dependency on airborne concentrations of the substance (CICAD 3 (1998)). While, in 277 individuals exposed chronically to the substance, 75 caused symptoms and 55 had enlarged livers (PATTY, 5th (2001)). Moreover, it was reported that chronic intoxication by the substance could take two forms: one was the effects on central nervous system such as tremor, vertigo and headache, and the other was gastrointestinal and hepatic symptoms containing nausea, vomiting, gastric pain, jaundice, and enlargement of the liver (HSDB (2005)). Based on the information, the substance was classified as Category 1 (central nervous system, liver). Besides, in animal studies, symptom of lethargy was observed at the dose level of 208 mg/kg in the 3-week oral dose study in rats (SIDS (Access on Jun. 2009)), and the effects on the liver such as increased activities of hepatic enzymes containing ALT, vacuolation, hypertrophy and necrosis of hepatocytes, or focal pigmentation were observed at the dose levels greater than 80 mg/kg in rats and at greater than 160 - 200 mg/kg in mice, respectively, in the 14-week oral dose studies in rats and mice (NTP TOX-49 (2004)).
10 Aspiration hazard Classification not possible - - - - Although its coefficient of kinematic viscosity (0.98 mm2/s) at 28.89 degrees centigrade is less than 20.5 mm2/s, this substance is a chlorinated hydrocarbon and outside the scope of the guidance criteria, and no information on adverse effects on respiratory tract by aspiration in the human case are available . Therefore it was classified as "Classification not possible".

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 2 from its 48h-EC50 = 9.3 mg/L for crustacea (Daphnia magna) (SIDS, 2005), etc.
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified as "Not classified" based on 28d-NOEC = 6.9 mg/L for crustacea (Daphnia magna) (SIDS, 2005), etc., though its acute toxicity is Category 2.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

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MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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