GHS Classification Result (Revision of the past classification result)

Chemical Name:Methylisobutylketone
CAS:108-10-1

Result:
ID: 21B3061
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 2 Danger H225: Highly flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
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.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Classified into Category 2 since flash point 14 degC (ICSC (J) (1997), IUCLID (2000)), 18 degC (NFPA (13th, 2006)) are <23 degC and boiling point 117 - 118 degC (ICSC (J) (1997), Merck (14th, 2006)), 117.4 degC (Howard (1997)) are >35 degC.
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 460 degC (ICSC (J) (1997)), 448 degC (NFPA (13th, 2006)) and 457 degC (Weiss (2nd, 1986)) 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) Not classified - - - - Based on LD50 values of 2080 mg/kg (ACGIH (2001)), 3200 mg/kg (PATTY (5th, 2001)), 4500 mg/kg (ACGIH (2001)), 4540 mg/kg (PATTY (5th, 2001)), 4570 mg/kg (EHC 117 (1990)) and 4600 mg/kg (EHC 117 (1990)) for rats, the substance was classified into "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).
1 Acute toxicity (Dermal) Not classified - - - - Based on a LD50 value of >16000 mg/kg for rabbits (IUCLID (2000)), the substance was classified as "Not classified".
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.
P501: Dispose of contents/container to ...
Since a LC50 (4h) value of 8.2 - 16.4 mg/L in rats (EHC 117 (1990)) corresponds to Category 3 or 4, the category with higher hazard was adopted and the substance was classified into Category 3. Since the LD50 value is lower than saturated vapour pressure concentration (26,184 ppmV), the test was considered to be conducted for vapour with almost no included mists and classification criteria for gas was adopted.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - There is a result that a 10-hour occluded application to the skin of rabbits produced erythema, which occurred immediately after the application and persisted for up to 24-hour (which means that the effect resolved after 24-hour) (EHC 117 (1990). There are results of "slightly irritating" and "not irritating" in other test by 24-hour application to the skin of guinea pigs and rabbits (DFGOT vol. 13 (1999), PATTY (5th, 2001)). Based on these results, the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 or "Not classified" in GHS classification).
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes 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.
There was a report that irritation was observed within 10 min when instilled in the rabbit eye; conjunctival swelling occurred within 8-hour. The inflammation, swelling and exudate present at 24-hour disappeared by 3 days (EHC 117 (1990)). The result of "mildly irritative" was reported in a rabbit Draize test where the irritation score was 5 (max 110) (DFGOT vol. 13 (1999)). Based on these data, the substance was classified into Category 2B. As relevant information, the substance is classified into R37 in EU classification.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on a report of "not sensitizing" in a Magnusson-Kligman maximization test using guinea pigs (DFGOT vol. 13 (1999)), the substance was classified as "Not classified".
5 Germ cell mutagenicity Not classified - - - - Based on a negative result in a mouse erythrocyte micronucleus test by intraperitoneal administration (in vivo somatic cell mutagenicity test) (EHC 117 (1990)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of negative for Ames tests (EHC 117 (1990)), rat liver cell chromosomal aberration tests (EHC 117 (1990)) and mouse lymphoma tests (PATTY (5th, 2001)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer 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 rat 2-year inhalation test, there were increases in the incidence of renal tubule adenoma and carcinoma in males and increases in the incidence of mononuclear cell leukemia in males. The incidences in the higher dose groups were also significantly increased (NTP TR538 (2007)). Additionally, in a mouse 2-year inhalation test, significantly increased incidences of liver neoplasms were observed in males and females (NTP TR538 (2007)). Based on the conclusion that there was some evidence of carcinogenic activity for the substance (NTP TR538 (2007)), the substance was classified into Category 2.
7 Reproductive toxicity Not classified - - - - In a two-generation inhalation test (IRIS (2003)), depressed body weight gain was observed in the high-dose group of F0 female rats during weeks 1 - 2 and F1 female through mating. F1 males showed transient or consistently depressed body weight at all dose groups. The only effect reported in offspring was significantly depressed body weights on day 14 post-partum in F1 and F2 male and female pups. No other changes were observed in any reproductive or developmental endpoint. In a developmental toxicity test by inhalation exposure to rats and mice during organogenesis period (EHC 117 (1990)), maternal toxicity with decreased body weight gain and clinical signs, and fetotoxicity with reduced fetal body weight per litter and delays in skeletal ossification were observed in rats. In mice, exposure to high concentration produced maternal toxicity with increased mortality, paresis, irregular gait, and fetotoxicity (increased incidence of dead fetuses, reduced fetal body weight per litter). There was no treatment-related increase in embryotoxicity or fetal malformations, i.e. teratogenicity. The increased incidence of dead fetuses (0.6% vs. control value 0.1%) cannot be disregarded. However, since the adverse effect was only observed in the high dose group in which maternal death (3/25) occurred, this data was not used as the basis of classification. Since there were no adverse effects on parental sexual function and fertility in the two-generation inhalation test in rat and no adverse effects on fetal development in the rat and mouse developmental toxicity tests, the substance was classified as "Not classified".
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation, Narcotic effects) Warning H335: May cause respiratory irritation (respiratory tract irritation, narcotic effects) 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.
P405: Store locked up.
P501: Dispose of contents/container to ...
In an inhalation test in guinea pigs, irritation of the eyes and nose was observed in relatively low concentrations (EHC 117 (1990)). Irritation of the nose and throat was reported in humans after inhalation exposure (EHC 117 (1990), PATTY (5th, 2001), IRIS (2003)) and in some cases individuals complained about respiratory irritation (EHC 117 (1990). Based on these results, the substance was classified into Category 3 (respiratory tract irritation). Narcosis was observed in inhalation tests in guinea pigs and mice (EHC 117 (1990), PATTY (5th, 2001)), and rats exhibited CNS depression, loss of coordination and collapse in another test (PATTY (5th, 2001)). In addition, central nervous system depressant, dizziness and narcosis were reported in humans following inhalation exposure (EHC 117 (1990), IRIS (2003), ECETOC JACC (1987)). Based on the data, the substance was classified into Category 3 (narcotic effects). Severe central nervous system depressant and histopathological findings including fatty livers and congestion of the brain are also reported in guinea pigs and rats (EHC 117 (1990)), however, the findings were observed at high dose levels exceeding the guidance value range.
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system) Danger H372: Cause damage to organs through prolonged or repeated exposure (nervous system) 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 ...
Effects on the kidney including nephropathy and hyperplasia of renal tubular cell were observed after oral administration for 13 weeks or 120 days to rats (DFGOT vol. 13 (1999), IRIS (2003)). In 13-week inhalation tests in rats and mice, increased liver weight, changes in platelet count, cholesterol, urine glucose and protein were observed, and the only renal histopathological lesion observed was hyaline droplet formation specific to male rats (IRIS (2003)). However, these results were not used as the basis of classification since these findings were observed at high dose levels exceeding the guidance value range. For humans, more than half of the 19 workers exposed to the substance in a work environment complained of weakness, loss of appetite, headache, stomach ache, nausea and vomiting, and a few of the workers experienced insomnia, somnolence, heartburn and intestinal pain. 5 years later, when the working environment had been significantly improved, a few workers still complained of gastrointestinal and central nervous system effects (EHC 117 (1990)). There are two further case reports of peripheral neuropathy probably associated with exposure of the substance (EHC 117 (1990)). Based on the epidemiological information, the substance was classified into Category 1 (nervous system).
10 Aspiration hazard Classification not possible - - - - Although the kinematic viscosity is estimated to be 20.5 mm2/s or less at 40 degC, extrapolated from kinematic viscosity of 0.691 mm2/s at 25 degC (calculated from a viscosity coefficient in Solvents Handbook, Ohmsha Ltd. (1997)), classification was not possible since the substance is not a hydrocarbon. As relevant information, there is a report that "because of its low viscosity, the substance may, when swallowed, be aspirated into the lungs causing chemical pneumonitis" (EHC 117 (1990)). In a rat model test, aspiration into the lung resulted in deaths in all treated animals (PATTY (5th, 2001)).

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 = 505 mg/L for fish (Fathead minnow) (ECETOC TR91, 2003) and 24h-LC50 = 1550 mg/L for Crustacea (Daphnia magna) (EHC 117, 1990).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since its acute toxicity is Not classified and it is not non-water soluble (Water solubility = 19000 mg/L (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)


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