GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 112-34-5 |
| Chemical Name | Diethylene glycol mono butyl ether [2-(2-buthoxyethoxy)ethanol] |
| Substance ID | H27-B-008/C-029B_P |
| Classification year (FY) | FY2015 |
| 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 | FY2009 FY2008 |
| 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 |
| 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 present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 6 | Flammable liquids | Category 4 |
Warning |
H227 | P370+P378 P403+P235 P210 P280 P501 |
Based on a flash point of 78 degrees C (closed cup) (HSDB (Access on June 2015)), it was classified in Category 4. |
| 7 | Flammable solids | Not applicable |
- |
- | - | "Liquids" according to 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 ignition point of 204 degrees C (HSDB (Access on June 2015)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No established test method suitable for liquid substances. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Not containing 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 which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an organic compound that does not contain bivalent -O-O- structure in the molecule. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | From reported LD50 values of 5,660 mg/kg (ACGIH (7th, 2013), DFGOT vol. 7 (1996)), 5,080 mg/kg (females), 6,530 mg/kg (males), 6,560 mg/kg (PATTY (6th, 2012)), 9,600 mg/kg (fed), 7,300 mg/kg (fed) (ACGIH (7th, 2013)), 9,623 mg/kg (fed), and 7,292 mg/kg (fasted) (PATTY (6th, 2012), EU-RAR (1999), ECETOC TR 64 (1995)) for rats, it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From reported LD50 values of > 2,000 mg/kg (DFGOT vol. 7 (1996)) for rats and 2,764 mg/kg (PATTY (6th, 2012), EU-RAR (1999), ECETOC TR 64 (1995)), 3,000-4,000 mg/kg (DFGOT vol. 7 (1996)), and 4,000 mg/kg (PATTY (6th, 2012)) for rabbits, it was classified as "Not classified" (Category 5 in UN GHS classification). |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. The classification is not possible only with the data that no deaths were reported after 7-hour exposure to the saturated vapour (28.8 ppm) in rats (converted to a 4-hour equivalent: 38.1 ppm) (EU-RAR (1999), ECETOC TR 64 (1995)). |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that slight irritation was observed after application of this substance (undiluted) in rabbits or guinea pigs (PATTY (6th, 2012)), and it is written that slight irritation was found after long-term or repeated application to rabbit skin (ECETOC TR64 (2005), BUA 204 (1997)). Besides, it is decided in EU-RAR (1999) that the category of skin irritation should not be allocated because effects were not observed after repeated dermal administration (2000mg/kg) using rabbits or rats (EU-RAR (1999)). It is reported that some persons showed erythema in a patch test with undiluted liquid in humans, but details are unknown (DFGOT vol. 7 (1996)). From the above results, the substance 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 |
It is reported that moderate eye irritation was observed after application of 0.1 mL this substance to rabbit eyes, but resolved within 14 days (ECETOC TR 64 (1995), ACGIH (7th, 2001), PATTY (6th, 2012)). Besides, the substance is classified in "Eye Irrit. 2 H319" in EU CLP classification (ECHA CL Inventory (Access on June 2015)). From the information of moderate irritation and reversibility, it was classified in Category 2A in accordance with Guidance. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported in a Maximization test using guinea pigs that sensitization was not observed (ECETOC TR. 64 (1995), BUA 204 (1997)) and that it was not sensitizing (EU-RAR (1999)). However, they were judged as insufficient data to be used for the classification due to unknown details on results and so on. The classification was revised by reviewing information. |
| 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 in mouse bone marrow cells was negative (DFGOT vol. 7 (1996), EU-RAR (1999), ACGIH (7th, 2013), PATTY (6th, 2012)). Moreover, as for in vitro, there is a weakly positive result in a mouse lymphoma test, but other tests, namely, a bacterial reverse mutation test, and a chromosomal aberration test, a gene mutation test, and an unscheduled DNA synthesis test in cultured mammalian cells were negative. (ACGIH (7th, 2013), DFGOT vol. 7 (1996), EU-RAR (1999), PATTY (6th, 2012)) |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Due to no classification by other organizations, the classification is not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | There is no information on reproductive effects in humans. As for experimental animals, in a 1-generation test in which either male or female rats were administered this substance by gavage before mating and mated with non-exposure animals, toxic effects on fertility of male and female parent animals were not observed at doses up to 1,000 mg/kg/day. However, F1 pups at 1,000 mg/kg/day showed weight gain reduction during a late nursing period (EU-RAR (1999)). Moreover, also in a 1-generation test in rats in a dermal application at 2,000 mg/kg/day for 13 weeks from prior to mating and for females until day 20 of gestation, toxic effects on fertility were not observed in either males or females (EU-RAR (1999), ACGIH (7th, 2013)). On the other hand, as developmental toxicity effects, it is written that in a developmental toxicity test in pregnant female rats in gavage administration during an organogenetic period (day 6-15 of gestation), effects were not found in a number of live births, survival rate by day 3 after birth of newborns, and body weight transition even administered up to the high dose (2,050 mg/kg/day) where 25% of maternal animals died (teratogenicity was not a target for evaluation), and that in a teratogenicity test in pregnant female rats in diet administration during the whole gestation period, pre and postnatal developmental effects were not observed even at the dose where maternal animals showed weight gain reduction (EU-RAR (1999), ACGIH (7th, 2013)). Moreover, it is written that in a teratogenicity test in pregnant rabbits in an occlusive dermal application during an organogenetic period (day 8-19 of gestation), statistically not significant but a trend of weight gain reduction was observed in maternal animals, which were administered up to the dose where skin irritation was observed, but fetuses did not show developmental toxicity including malformations (EU-RAR (1999), ACGIH (7th, 2013)). As above, it is thought that in experimental animals, toxic effects on fertility of parent animals and developmental toxicity effects including malformation almost do not occur in 2 routes of oral and dermal. However, because in a 1-generation test in rats in an oral route, results suggesting growth suppression were obtained in pups born at the high dose during a nursing period, it was judged that data are not sufficient to classify as "Not classified" including information in humans. Therefore, the substance was classified as "the classification is not possible" in this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (Narcotic effects) |
Warning |
H336 | P304+P340 P403+P233 P261 P271 P312 P405 P501 |
There is no human information. As for experimental animals, deaths occurred in oral administration at 2,000 mg/kg corresponding to Category 2 in rabbits, and prone position, transient atonia, prostration, rapid breathing, narcotic signs, and kidney damage were observed at 1,060 mg/kg (DFGOT vol. 7 (1996)). Moreover, there is the information that "this substance has low acute toxicity in oral and dermal routes," "toxic signs before death in orally dosed mice and rats were hypoactivity, labored breathing, anorexia, weakness, and tremors," but the dose is above Category 2, and "anorexia, enlargement of the kidney, discoloration of the renal pelvis, and edema and hemorrhagic lesions in the thymus in dermal exposure in rabbits" were observed, but the dose is above Category 2 (above EU-RAR (1999)). From the above, effects on the kidney were considered in dermal exposure in rabbits, but kidney was not taken as a target for classification due to the dose above Category 2. Because other findings were caused by narcotic effects, it was classified in Category 3 (narcotic effects). The previous classification was revised by confirming information. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs, liver) |
 Danger |
H372 | P260 P264 P270 P314 P501 |
There is no human information. As for experimental animals, in a 5-week inhalation toxicity test using rats, increased relative liver weight and hepatocellular fatty degeneration were observed at 117 mg/m3 (converted to a Guidance value equivalent: 0.0325 mg/L) (EU-RAR (2000)). Moreover, in a 2-week inhalation toxicity test using rats, perivascular and peribronchial cellular infiltration of granulocytes, bronchiolization, and increased lung weight were found at 100 mg/m3 (converted to a Guidance value equivalent: 0.011 mg/L) (EU-RAR (2000)). All of these were observed within a range of Category 1. Besides, hemolysis was found as effects on blood system (red blood cells), but at the dose above a range of Category 2. In a 6-week gavage administration toxicity test using rats, hemolytic anemia, increased liver weight, and hyperkeratosis and acanthosis of the forestomach were observed (EU-RAR (2000), PATTY (6th, 2012), DFGOT vol. 7 (1996)), and in a 13-week drinking water administration toxicity test using rats, hemolytic anemia and increased liver weight were found (PATTY (6th, 2012)). These were at the doses above a range of Category 2. Systemic effects were not observed in a 13-week dermal administration toxicity test using rats (EU-RAR (2000), PATTY (6th, 2012)). Therefore, the substance was classified in Category 1 (respiratory system, liver). The previous classification was "the classification is not possible" because toxicity effects were not clear in an inhalation route. However, the classification was possible by the information obtained in an inhalation route. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, a kinematic viscosity value was calculated to be 0.069 mm2/sec (20 degrees C) from numerical data (viscosity: 0.0649 mPa*s; density (specific gravity): 0.9536) listed in HSDB (Access on June 2015). |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Not classified |
- |
- | - | From 96-hour EC50 >100 mg/L for algae (Desmodesmus subspicatus), 48-hour EC50 >100 mg/L for crustacea (Daphnia magna), and 96-hour LC50 = 1300 mg/L for fish (Lepomis macrochirus) (all EU-RAR, 1999), it was classified as "Not classified." |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Reliable chronic toxicity data were not obtained. Due to not water-insoluble (water solubility = 1000000 mg/L, PHYSPROP Database 2009), and "Not classified" in acute toxicity, it was classified as "Not classified." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
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. |