GHS Classification Result （Revision of the past classification result）

Chemical Name：Ethylene glycol mono-n-butyl ether, (Butyl cellosolve)
CAS：111-76-2

Result：
ID: 21B3020
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government （March, 2009）

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 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 ... 		Flash point is >60 degC and <=93 degC from the description of flash point 62 degC (closed-cup) (SIDS (Access on 4. 2009)), 141 degF (60 degC) (converted value: 60.55 degC) (closed-cup) (Merck (14th, 2006)).
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 - - - - Auto-ignition point is 240 degC (Hommel (1996)) exceeding 70 degC.
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) in the molecule which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds 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） 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 ... 		LD50 values are 1746 mg/kg (male), 1950 mg/kg (female), 2410 mg/kg (male) (SIDS (1997)), 1480 mg/kg, 1590 mg/kg (male), 2417 mg/kg, 2400 mg/kg (ATSDR (1998)), 917 mg/kg and 470 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 6 (2008)). Since seven values correspond to Category 4 and three values correspond to Category 5, the substance was classified into Category 4.
1 Acute toxicity （Dermal） Category 3 Danger H311: Toxic in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment （see ... on this label）.
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ... 		LD50 values are 610, 99, 435, 567 (male), 635 mg/kg (female) (SIDS (1997)), 220, 580, 638 (male) and 568 mg/kg (female) (ATSDR (1998)) for rabbits, one value corresponds to Category 2 and eight values correspond to Category 3. A LD50 value of 2273 mg/kg for rats (ATSDR (1998)) corresponds to Category 4. The data for rabbits with higher hazard was adopted and the substance was classified into Category 3.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Category 2 Danger H330: Fatal 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.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P284: Wear respiratory protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P320: Specific treatment is urgent （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on LC50 (4h) values of 2.4 mg/L (486 ppm)(male) and 2.2 mg/L (450 ppm)(female) (SIDS (1997)) and 500 ppm (ATSDR (1998)) for rats, the substance was classified into Category 2. Since the LD50 values were lower than 90% of saturated vapour pressure concentration (1158 ppm), the classification criteria for gas was adopted.
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. 		Based on a result of "irritating" in a rabbit test (similar to OECD TG404) where severe erythema with eschar and oedema were observed in 3/6 rabbits after a 4-hour application (SIDS (1997)), the substance was classified into Category 2. As relevant information, there is a report that some reddening of the skin and contact dermatitis occurred in cleaners using floor strippers containing high levels of the substance (SIDS (1997)).
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 rabbit Draize tests (OECD TG405 (GLP)), corneal opacity, iritis, conjunctival redness and chemosis were observed. Corneal opacity and iritis reversed but conjunctival redness and chemosis persisted at 7 days after application. The MMAS (Maximum Average Score) was calculated to be 68.7 (ECETOC TR48 (1998)). Since the MMAS value corresponds to an AOI (acute ocular irritation index) of 30 - 80 and conjunctival redness and chemosis were observed after 7 days, the substance was classified into Category 2A.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on negative results in 2 maximization tests using guinea pigs (SIDS (1997)) and a human repeated insult patch test (SIDS (1997)), the substance was classified as "Not classified".
5 Germ cell mutagenicity Not classified - - - - Based on negative results in rat and mouse bone marrow micronucleus tests by intraperitoneal administration (in vivo somatic cell mutagenicity test) (SIDS (1997), CICAD 10 (1998)) and a report that no increases in micronuclei or sister chromatid exchanges were observed in epidemiological research (ATSDR (1998)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of negative results for an Ames test (SIDS (1997)), a human lymphocyte chromosomal aberration test (ECETOC 95 (2005)), a chromosomal aberration test, a gene mutation test using CHO cells (SIDS (1997)) and a CHL cell gene mutation test (ATSDR (1998)).
6 Carcinogenicity Not classified - - - - The substance is classified into "Group 3" in IARC (IARC 88 (2006)), "A3" in ACGIH (ACGIH (7th, 2003)) and "C" in EPA (IRIS (1999)). Although these assessment documents classified the substance in different categories, it was classified as "Not classified" in accordance with the latest classification in IARC ("Group 3"). In 2-year inhalation tests in rats and mice, incidences of forestomach squamous cell papilloma was significantly increased in females and the incidence of hemangiosarcoma of the liver was significantly increased in males (NTP 484 (2000)).
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 ... 		Inhalation of the substance by rats and rabbits throughout gestation was associated with embryotoxicity, as evidence by a decreased number of implantations and an increased number of resorptions. At the same doses, dams exhibited general toxicity such as decreased body weight, increased kidney weight and changes in hematological parameters (SIDS (1997)). Based on the data the substance was classified into Category 2. An epidemiology test suggested the risk of cleft lip, however, the association with the substance is not clear (PATTY (5th, 2001)).
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, blood, kidney, liver), Category 3 (respiratory tract irritation) Danger
Warning 		H370: Causes damage to organs (central nervous system, blood, kidney, liver)
H335: May cause respiratory irritation (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. 		The effects on erythrocyte are characteristic in animals exposed to the substance (SIDS (1997)). There are human cases that demonstrated hematological effects such as decreased hemoglobin and/or erythrocyte counts, and hemoglobinuria. Additionally, it is reported that exposed individuals exhibited symptoms such as coma, dizziiness, breathing difficulties, metabolic acidosis, hematuria and liver dysfunction (SIDS (1997)). There are some reports of severe cases resulting in hospitalization of the exposed individuals (SIDS (1997), PATTY (5th, 2001)). Based on all human information, the substance was classified into Category 1 (central nervous system, blood system, kidney, liver). In addition, since there are reports of "nasal and throat irritation" in a human inhalation test (SIDS (1997)) and "recurrent respiratory irritation, and dry cough" in a case report (HSDB (2004)). Based on these results, the substance was classified into Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 2 (blood) Warning H373: May cause damage to organs through prolonged or repeated exposure (blood) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In a 90-day inhalation test, male and female rats exposed to 77 ppm exhibited hematological changes such as a decrease in red blood cell count, hemoglobin concentration and hematocrit as well as an increase in mean corpuscular hemoglobin (SIDS (1997)). In a 14-week inhalation test in male and female rats, anemia was present in males rats at 125 pm or higher concentrations and in female rats of all exposed groups. The anemia was characterized as normochromic and regenerative (PATTY (5th, 2001)). Based on these evidences of anemia, the substance was classified into Category 2 (blood system).
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 - - - - Classified into Not classified from its 96h-LC50 >116 mg/L for fish (Sheepshead minnow) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 6 (2008), etc) and 96h-LC50 >130 mg/L for Crustacea (Penaeus) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 6 (2008), etc).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified into Not classified since it is rapidly degradable (BOD degradation rate: 96% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1976)) and low bioaccumulative potential is estimated (log Kow = 0.83 (PHYSPROP Database, 2009)).
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
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information