GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 591-78-6 |
| Chemical Name | Methyl n-butyl ketone |
| Substance ID | H27-B-064/C-100B_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 | FY2006 |
| 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 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 3 |
 Warning |
H226 | P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Based on a flash point of 25 deg C (closed cup) (HSDB (Access on August 2015)), it was classified in Category 3. Besides, it is classified in Class 3, PG III (UN 1224 (KETONES, LIQUID, N.O.S.)) in UNRTDG. |
| 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 |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 423 deg C (ICSC (1998)). |
| 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 is an organic compound containing 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 |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on a report of an LD50 value of 2,590 mg/kg (PATTY (6th, 2012), IRIS Tox. Review (2009), ACGIH (7th, 2001), ATSDR (1992)) for rats, this substance was classified as "Not classified" (Category 5 in the UN GHS classification). |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on a report of an LD50 value of 5.99 mL/kg (4,944 mg/kg) (PATTY (6th, 2012)) for rabbits, this substance was classified as "Not classified" (Category 5 in the UN GHS classification). |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. There is a report that as a result of 4-hour inhalation in rats at 4,000 ppm, no death was observed (PATTY (6th, 2012)), but it was not possible to identify the category from this value alone. Besides, since the test concentration was lower than 90% of the saturated vapor pressure concentration (5,000 ppm), a reference value in the unit of ppm was applied as vapor without mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | Based on a report of an LC50 value (4 hours) of 32.8 mg/L for rats (GESTIS (Access on August 2015), RTECS (Access on August 2015) original reference: Raw Material Data Handbook, Vol.1: Organic Solvents, 1974.), this substance was classified as "Not classified." Besides, the reference value of mist was applied because the LC50 value is higher than the saturated vapor pressure concentration (20.5 mg/L). The new information was added, and the Category was reviewed. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | There is a report that in a skin irritation test with rabbits, as the result of application with an undiluted solution of this substance for 24 hours, slight irritation was observed (ATSDR (1992), PATTY (6th, 2012)). From the above, this substance was classified as "Not classified" (Category 3 in the UN GHS classification). |
| 3 | Serious eye damage/eye irritation | Category 2A |
 Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
There is a report that moderate irritation was observed in an eye irritation test with rabbits (ATSDR (1992)). In addition, there is a report that as the result of exposure to 1,000 ppm of this substance in volunteers, moderate irritation was observed (ACGIH (7th, 2001), PATTY (6th, 2011)). From the above, this substance was classified in Category 2A based on reports of moderate irritancy. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | There is no information on carcinogenicity in humans. As for experimental animals, there is a description that in a 2-year carcinogenicity study with rats and mice exposed by inhalation, renal tubule hyperplasia and an increase in incidence of adenoma or carcinoma in the renal tubules were observed at 1,800 ppm in rats (ATSDR Addendum (2014)), but the original source was unknown (only the author and title were identified), and it was not possible to confirm detailed content. Other than this, there is no data available. As classification results by other organizations, it was only classified as "I (Inadequate to assess human carcinogenic potential)" in evaluation in 2009 by EPA (IRIS Summary (Access on August 2015)). Therefore, it was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government. |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
It is described that in tests in which male rats were exposed by inhalation to 700 ppm of this substance for 11 weeks, or orally dosed at 660-1,400 mg/kg/day for 90 days, testicular toxicity (atrophy of testis, degeneration of germinal epithelium, etc.) was observed (ATSDR (1992), ACGIH (7th, 2001), PATTY (6th, 2012)), but there is no study report that considered the effects on fertility on mating with females. However, when pregnant rats were exposed by inhalation at doses of 500-2,000 ppm throughout the gestation period, the F1 pups were maintained and nursed from birth to mature animals (adults), and during this period, behavioral observation was performed at the neonatal period, weaning period, puberty, and maturation period. It is described that as a result, in maternal animals, decreased body weight gain and decrease in the number of litters were observed at or above 1,000 ppm, and in F1 pups, in behavioral tests at or above 1,000 ppm, a decrease in avoidance learning behavior in female animals in puberty, an increase in locomotor activity (open field test) in animals in puberty and maturation period were observed, and a low value of mortality and body weights at 2,000 ppm were observed (ATSDR (1992), ACGIH (7th, 2001), PATTY (6th, 2012)). Considering that this substance is a nervous system acting substance, it was judged to be reasonable to regard the findings by postnatal neurobehavioral examination by fetal exposure as effects of test substance administration. Therefore, it was classified in Category 2 for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (peripheral nervous system), Category 3 (respiratory tract irritation, narcotic effects) |
Danger Warning |
H370 H335 H336 |
P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
There are reports that this substance has respiratory tract irritating potential and narcotic effects in humans (ACGIH (7th, 2001), PATTY (6th, 2012), ATSDR (1992)), and in the case of inhalation and dermal exposure, three workers developed peripheral neuropathy during spray painting of this substance (ACGIH (7th, 2001)). From the above, this substance was classified in Category 1 (peripheral nervous system), Category 3 (respiratory tract irritation, narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
Many cases of workers who were exposed to this substance in solvent painting work etc. and developed peripheral neuropathy are reported. Also, in typical cases, it is reported to follow courses of weakness, feet discomfort, development of muscle weakness progressing from the lower extremities to the lower-body, and to the upper arms, and the lower or diminished reflex function of lower extremities (IRIS Tox Review (2009)). In addition, there is a description that by observation of sural nerve specimens collected by biopsy, diffuse fibrosis, loss of nerve fibers, and swelling of axons with tangles of nerve fibers were observed (IRIS Tox Review (2009)). Moreover, there is a description that although the degree is different, chronic occupational exposure to this substance was associated with the onset and progression of symmetrical central-peripheral distal axonopathy (ACGIH (7th, 2001)). As for experimental animals, there are descriptions that in studies in which male rats or male cynomolgus monkeys were exposed by inhalation of this substance (assumed to be vapor) at 100 or 1,000 ppm for 10 months, a decrease in motor conduction velocity (MCV) for the sciatic-tibial nerves was observed in a dose- and time-dependent manner in both rats and monkeys at or over 100 ppm (0.41 mg/L/6hr) corresponding to Category 2, and a decrease in the induced muscle action potential amplitude in response to the sciatic nerve stimulation was observed at or above 100 ppm in rats and 1,000 ppm in monkeys (IRIS Tox Review (2009)). Also, there is a description that in a 2-year inhalation study with cats, as neuropathological changes, degeneration of nerve axon and swelling of axons with myelin loss were found in both peripheral nerve and central nerve at 330 ppm (1.35 mg/L/6 hr) (IRIS Tox Review (2009)). On the other hand, also in the oral route, in a study in which rats were dosed with this substance in drinking water for 13 months, swelling of peripheral axons and myofibrillar atrophy in skeletal muscle were observed at or above 250 ppm (143 mg/kg/day), and changes in axons in the brain, spinal cord, and peripheral nerve were developed in all, but in the brain, it was less frequent than in the other sites (IRIS Tox Review (2009)). From the above, although it is clear from many epidemiological reports on humans that this substance causes peripheral neuropathy, it is shown from neuropathological examinations of experimental animals that neural axon tissue changes occurred at low frequency also in the central nervous system, therefore, it was considered that effects on the central nervous system develop at least morphologically even in humans. Therefore, it was classified in Category 1 (nervous system) for this hazard class. Besides, Category 2 (testis) was adopted in the previous classification. Although, as described in the hazard class for "reproductive toxicity," testis toxicity was observed in repeated exposure by the inhalation or oral route to this substance, it was excluded from this classification since they are findings at doses exceeding Category 2. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | There are no cases of hazard to the respiratory organs due to aspiration in humans. However, this substance belongs to ketones composed of carbon atoms of 3 or more and not more than 13. The calculated kinematic viscosity value is 0.747 mm2/sec (20 deg C) from the numerical data (Viscosity: 0.62 mPa*s (20 deg C), density (specific gravity): 0.830 g/cm3 (20 deg C)) listed on HSDB (Access on August 2015). From the above, it corresponds to Category 2 in UN GHS classification, but it was classified as "Classification not possible" according to the current GHS classification guidance for the Japanese Government revised after the previous classification. |
| 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 LC50 = 428 mg/L for fish (Pimephales promelas) (HSDB, 2006, AQUIRE, 2016), 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 being not water-insoluble (water solubility = 17200 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 available. |
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. |