GHS Classification Result

Chemical Name：2,2' -oxybisethanol; diethylene glycol
CAS：111-46-6

Result：
ID: 20A2042
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

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 molecules.
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 Not classified - - - - Its flash point is 124degC (ICSC (2007)), which is above 93degC.
7 Flammable solid 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 - - - - Its autoignition point is 229degC (ICSC (2007)), which is above 70degC.
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 - - - - The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - All of the rat LD50 values documented (15.6, 16.6, and 20.8g/kg bw) (PATTY 5th (2001)) fall within "Not classified".
1 Acute toxicity （Dermal） Not classified - - - - Based on the rabbit LD50 of 13300mg/kg bw (DFGOT vol. 10 1998), the substance was classified into "Not classified".
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - There was no mortality in rats exposed to 4500mg/m3 (mist) for 4 hours (DFGOT (vol. 10, 1998)). However, since no other data were available, classification is not possible.
2 Skin corrosion/irritation Not classified - - - - Skin irritation tests using rabbits (Draize tests) concluded that the substance was slightly irritating (IUCLID (2000)). Similarly, 48-hour application to humans and repeated application to guinea pigs suggested that the substance produced no skin irritation (DFGOT vol. 10 (1998). Thus, the substance was classified into "Not classified" using JIS classification criteria (Category 3 in the United Nations GHS classification).
3 Serious eye damage/eye irritation Not classified - - - - Since no irritation was detected in rabbit tests (DFGOT vol. 10 (1998), PATTY (5th, 2001)), the substance was classified into "Not classified".
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Since skin sensitization tests using guinea pigs (maximization tests) (DFGOT vol. 10 (1998)) and patch tests in humans (IUCLID (2000)) provided no evidence of sensitization. The substance was classified into "Not classified".
5 Germ cell mutagenicity Classification not possible - - - - Among in vivo chromosomal aberration tests using hamsters, intraperitoneal administration resulted in a slight increase in chromosomal aberrations in the form of gaps; and oral administration tests yielded ambiguous results (DFGOT vol. 10 (1998)). In micronucleus tests and dominant lethal tests, basic information such as animal species used, administration methods, and administration durations are lacking, and the results are inadequate and contain some uncertainty to assess the genotoxicity of the substance (DFGOT vol. 10 (1998), IUCLID (2000)). As such, the substance was classified into "Classification not possible". Most in vitro mutagenicity tests resulted negative (DFGOT vol. 10 (1998), NTP DB (accessed June 2008), IUCLID (2000)).
6 Carcinogenicity Classification not possible - - - - Decreased survival rates, as well as bladder tumors or kidney tumors have been documented in 2-year oral route exposure tests using rats (DFGOT vol. 10 (1998)). However, the data on bladder tumors were obtained from studies involving male rats only, and the data are old. Regarding kidney tumors, initiation / promotion tests conducted by the same author later revealed that diethylene glycol was not carcinogenic and does not have promotion effects (DFGOT vol. 10 (1998)). Other documented tests do not provide sufficient data either. As such, the substance was classified into "Classification not possible".
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In a 2-generation reproduction test using mice that were exposed to the substance prior to mating, reduced litter size, craniofacial malformations such as exencephaly and cleft palate were observed (DFGOT vol. 10 (1998)). Cleft palates have been also documented in hamsters that received intraperitoneal administration on day 8 of gestation (DFGOT vol. 10 (1998)). These toxic doses were also associated with decreased body weight of maternal animals and mortality in hamsters (DFGOT vol. 10 (1998)). That is to say, clear cases of reproductive toxicity are documented at doses that induce general toxicity in parental animals. As such, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Although specific acute toxicity symptoms that are common among different animal species, are documented (DFGOT vol. 10 (1998), PATTY (5th, 2001), their relationships to exposure doses are not documented. As such, classification is not possible.
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney, liver) Danger H372: Cause damage to organs through prolonged or repeated exposure (kidney, 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 ... 		In repeated oral route exposure using rats, increased excretion of oxalic acid, formation of calcium oxalate crystals, and kidney damage (nephrosis) were observed as common symptoms (DFGOT vol. 10 (1998)). Long-term exposure, bladder stones, kidney damage, and infrequent liver damage were also observed in some studies (PATTY (5th, 2001)). However, these symptoms were associated with much higher doses than the cutoff value of the guidance range (100mg/kg/day). In humans, several epidemiological studies have been conducted, which revealed many cases of death, progressive kidney damage followed by kidney failure, and a few cases of liver damage (DFGOT vol. 10 (1998)). Based on the results of the human epidemiological studies, with the results of the repeated exposure in rats taken into account, the substance was classified into Category 1 (kidney, liver).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Not classified - - - - Since its 96-hour LC50 = 75200mg/L for fish (fathead minnow) (AQUIRE, 2008), the substance was classified into "Not classified".
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Since it is water soluble (water solubility: 1,000,000mg/L (SRC, 2005)) and its classification for acute toxicity is "Not classified", the substance was classified into "Not classified".


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
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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