GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 108-83-8 |
| Chemical Name | Diisobutyl ketone |
| Substance ID | H27-B-059/C-095B_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 49 deg C (closed cup) (ICSC (1997)), it was classified in Category 3. Besides, it is classified in Class 3, PG III (UN 1157) 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 396 deg C (HSDB (Access on August 2015)). |
| 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 LD50 values for rats of > 2,000 mg/kg, 5,285 mg/kg (female), 6,933 mg/kg (male) (SIDS (2004)), and 5,750 mg/kg (5,800 mg/kg) (PATTY (6th, 2012), SIDS (2004), DFGOT vol. 18 (2002), ACGIH (7th, 2001)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on reports that an LD50 value for rats (OECD TG 402) was > 2,000 mg/kg (SIDS (2004)), and LD50 values for rabbits were 2,888 mg/kg (male), 6,933 mg/kg (female), 10,922 mg/kg (female) (SIDS (2004)), and 16,000 mg/kg (PATTY (6th, 2012), SIDS (2004), DFGOT vol. 18 (2002), ACGIH (7th, 2001)), it was classified as "Not classified." |
| 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. Although there is a report of an LC50 value (4 hours) for rats of > 5 mg/L (> 850 ppm) (OECD TG 403) (SIDS (2004)), it was not possible to identify the category from this value. Besides, since the LC50 value was lower than 90% of the saturated vapor pressure concentration (987-2,172 ppm), a reference value in the unit of ppm was applied as vapour without mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | As for skin irritation tests (OECD TG404) with rabbits, both results of slight irritation and no irritation are reported as a result of a semi-occlusive application of this substance for 4 hours (SIDS (2004)). In addition, there is a report that in other skin irritation test with rabbits, as a result of a semi-occlusive application of 0.5 mL of this substance for 4 hours, erythema (average score 1.9) and edema (average score 0.4) were observed, but resolved within 14 days after the application (SIDS (2004)). From the above, it was classified as "Not classified" (Category 3 in UN GHS classification). |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
There is a report that in an eye irritation test (equivalent to OECD TG 405) with rabbits, as a result of application of 0.1 mL of this substance, conjunctival redness (average score 0.3) and edema (average score 0.4) were observed, but resolved after 7 days (SIDS (2004)). In addition, there is a report that in other eye irritation test with rabbits, conjunctival redness, conjunctival edema, and lacrimation were observed, but resolved by day 2 (ECETOC TR48 (1992)). From the above, it was classified in Category 2B. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Not classified |
- |
- | - | There is a report that in a maximization test (OECD TG 406, GLP-compliant) with guinea pigs, no sensitization was observed in the control group and treated group, and the positive rate in the positive control group was 50% (SIDS (2004), PATTY (6th, 2012)). From the above, it was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. There was no in vivo data. As for in vitro, bacterial reverse mutation tests and a mammalian cell chromosome aberration test were negative (SIDS (2004), DFGOT vol. 18 (2002), NTP DB (Access on October 2015)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | There were no classification results by other organizations. Therefore, classification was 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 reproduction/developmental toxicity screening test (OECD TG 421) with rats dosed by gavage, at the limit dose of 1,000 mg/kg/day, decreased body weight gain (male) and the death of two maternal animals (2/10) during the lactation period were observed, but there were no effects on fertility of the parental animals, and macroscopic and histopathological changes were not observed in the genetic organs in survivors in both sexes. In addition, no adverse effects were observed in the number of offspring born, a trend in body weight, and a survival rate by postnatal day 5 (SIDS (2004), PATTY (6th, 2012)). However, it was difficult to classify it as "Not classified" with only this result since this test is a screening test. In addition, there is no other available data for classification. Therefore, classification was not possible due to lack of data for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, liver), 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 |
This substance is irritating to the respiratory tract (SIDS (2004), ACGIH (7th, 2001), DFGOT vol. 18 (2002), PATTY (6th, 2012)). There is a report of narcotic effects in humans and experimental animals, and it was reported that in inhalation exposure with rats (at doses corresponding to Category 1), central nervous system symptoms such as salivation, hypoactivity, tremors, coordination ataxia, reflex disturbance, and labored breath, and hind-limb paralysis, liver damage, and an increase in hyaline droplets in the proximal tubules of the kidneys (SIDS (2004), ACGIH (7th, 2001), DFGOT vol. 18 (2002), PATTY (6th, 2012)). Since an increase in hyaline droplets in the proximal tubules of the kidneys in rats was a finding only in males, it was not adopted as the target organ. From the above, this substance has effects on the central nervous system and liver in addition to respiratory tract irritation and narcotic effects, therefore, it was classified in Category 1 (central nervous system, liver), Category 3 (respiratory tract irritation, narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | There is a description that a 60-year-old laboratory assistant who was repeatedly exposed to this substance developed severe headaches and a 20-minute loss of sight after exposure for about a month (DFGOT vol. 18 (2002), PATTY (6th, 2012)). However, it is a case report of only one, and the target organ was not identified based on this information. As for experimental animals, in a test in which rats were exposed to the vapour of this substance for 6 weeks, an increase in liver and kidney weight at or above 252 ppm, and cloudy swelling of the liver and cloudy swelling of the convoluted renal tubules at high concentrations of 925-1,654 ppm were observed. The author judged that NOAEL and LOAEL were 534 ppm and 925 mm respectively, and SIDS also referred to these (SIDS (2004)). If LOAEL is 925 ppm, 1 ppm = 5.81 mg/m3 (ACGIH (7th, 2001)), the dose with effects on the liver and kidney exceeds the range for Category 2 (converted guidance value concentration: 2.07 mg/L/6 hr/day). However, when the increase in organ weight at 252 ppm is considered as an effect, the dose corresponds to the guidance value range for Category 2 (converted to guidance value: 0.56 mg/L/6 hr/day). In addition, there is a description that in a 6-week inhalation study with guinea pigs exposed in the same way, a decrease in liver weight was observed at 252 ppm to the contrary (SIDS (2004), ACGIH (7th, 2001)). On the other hand, there is a description that in the oral route, rats were dosed by gavage at 2,000 mg/kg/day of this substance for 90 days, there were no clear findings other than a decrease in blood sugar level, and neurotoxicity was not observed (DFGOT vol. 18 (2002), PATTY (6th, 2012)). From the above, from the existing findings, no hazard information that can be used for classification was available, therefore, it was classified as "Classification not possible." |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | There is no case in humans. Therefore, classification was not possible due to lack of data. Besides, since this substance is a ketone with carbon atoms of 13 or less and the calculated kinematic viscosity is 1.11 mm2/sec (21 deg C) (viscosity: 0.896 mPa*s (70 deg F), density (specific gravity): 0.8062: HSDB (Access on August 2015)), it corresponds to Category 2 in UN GHS classification. According to the current GHS classification guidance for the Japanese government, it was classified as "Classification not possible." |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 | P273 P501 |
From 24-hour LC50 = 65 mg/L for crustacea (Artemia salina) (SIDS, 2004), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 | P273 P501 |
Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (BioWin), and acute toxicity Category 3, it was classified in Category 3. |
| 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. |