GHS Classification Result

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 108-11-2
Chemical Name 4-Methyl-2-pentanol
Substance ID H26-B-103, R-046
Classification year (FY) FY2014
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)
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

PHYSICAL HAZARDS
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
It was classified in Category 3 based on a flash point of 40.5 deg C (closed cup) (GESTIS (Access on September 2014)).
Besides, it is classified in Class 3, PG III (UN2053) 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 335 deg C (GESTIS (Access on September 2014)).
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.

HEALTH HAZARDS
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 for rats (PATTY (6th, 2012), SIDS (2006), ACGIH (7th, 2001)), it was classified as "Not classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on a report of an LD50 value of 2,880 mg/kg for rabbits (PATTY (6th, 2012), SIDS (2006), ACGIH (7th, 2001)), it was classified as "Not classified" (Category 5 in 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. Although there is a report of an LC50 value (4 hours) of > 3,776 ppm for rats (SIDS (2006)), the category could not be specified only with this data. Besides, since the LC50 value was lower than 90% of the saturated vapour concentration (4,906 ppm), the reference value in units of ppm was applied as a vapour without a 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
-
-
- - Based on a report that in a skin irritation test with rabbits, very slight irritation was observed (SIDS (2006), ACGIH (7th, 2001), PATTY (6th, 2012)), it was classified as "Not classified" (Category 3 in UN GHS classification). According to the revision of the GHS classification guidance for the Japanese Government, the category was changed.
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
There are reports that moderate irritation was observed in an eye irritation test with rabbits (SIDS (2006), ACGIH (7th, 2001), PATTY (6th, 2012)). In addition, there is a report that in another test with rabbits, Draize scores 1, 24 and 72 hours after application were 11, 25 and 17, respectively (maximum value 110), and conjunctivitis, edema and corneal injury were observed but these disappeared within 7 days (SIDS (2006)). There is a report that eye irritation was observed by exposure to the vapour of this substance in humans (PATTY (6th, 2012)). From the above results, it was classified in Category 2A.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - There are descriptions that in a sensitization test with 30 guinea pigs (OECD TG 406, GLP-compliant), no reactions after the challenge were observed, and a reaction in the positive control group was acceptable (SIDS (2006), PATTY (6th, 2012)). From the above result, it was classified as "Not classified." The information in SIDS (2006) and PATTY (6th, 2012) was added, and the category was changed.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. There were no in vivo data. As for in vitro, it was negative in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (SIDS (2006), PATTY (6th, 2012)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data.
Besides, there were no data on this substance. However, in SIDS (2006), it was evaluated using data on Methyl isobutyl ketone (MIBK; CAS RN: 108-10-1) and 4-Hydroxy-4-methyl-2-pentanone (HMP; CAS RN: 123-42-2), which are metabolites of this substance, and it was concluded that "this substance is not anticipated to be selectively toxic to the embryo or fetus and is not teratogenic via inhalation exposure" based on the results.
For reference, information on reproduction of MIBK and HMP is described below.
MIBK:
In a two-generation reproductive toxicity study with rats by the inhalation route, no effects on fertility were observed even at a dose (2,000 ppm) where parental toxicities (decreased body weight gain, reduced food consumption) were observed (SIDS (2006)).
In a teratogenicity test with rats by the inhalation route, although slight effects (reduced fetal body weight, increased incidences of delayed ossification and skeletal variations) in fetuses were observed at a dose (3,000 ppm) where maternal toxicities (loss of coordination, negative pain reflex, paresis, muscular weakness in hindlimbs, piloerection, lacrimation, reduced weight gain, reduced food consumption, elevated relative kidney weight) were observed, no teratogenicity was observed. Moreover, also in a teratogenicity test with mice by the inhalation route, although slight effects (reduced fetal body weight, increased incidences of delayed ossification and skeletal variations) were observed, no teratogenicity was observed in fetuses at a dose (3,000 ppm) where maternal toxicities (death (3/25 animals), decreased body weight gain, irregular gait, hypoactivity, ataxia, negative pain reflex, unkempt fur, lacrimation, increases in the absolute and relative weight of the livers) were observed (SIDS (2006)).

HMP:
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats by the oral route (gavage), at a dose (1,000 mg/kg/day) where maternal toxicities (reduced weight gain, hematologic test value changes, blood chemical test value changes, relative organ weights changes, renal and hepatic histopathological lesions) were observed, slight changes in fertility (impregnation, implantations) and survival rate of pups were observed, and developmental index (total number of pups born, delivery index, live birth index, number of pups alive, viability index on day 4) tended to reduce (SIDS (2006)).
8 Specific target organ toxicity - Single exposure Category 3 (respiratory tract irritation, narcotic effects)


Warning
H335
H336
P304+P340
P403+P233
P261
P271
P312
P405
P501
This substance was irritating to the respiratory tract in humans (ACGIH (7th, 2001), HPV-IS (2008), HSDB (Access on September 2014)). As for experimental animals, there are reports of narcotic effects in a test in which rats were exposed by inhalation to the vapour of this substance at 19 mg/L (2 hours) and 8.4 mg/L (8 hours) (SIDS (2006), ACGIH (7th, 2001), HPV-IS (2008), HSDB (Access on September 2014)).
From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - There was no adverse finding in humans by repeated exposure. As for experimental animals, it was described that in a test in which rats were exposed by inhalation to the vapour of this substance for 6 weeks, even at a high concentration of 3.70 mg/L (converted guidance value: 1.70 mg/L/6 hours) corresponding to "Not classified," slight changes such as proteinuria and increased plasma ALP were observed. However, there were no histopathological aberrations in any organs, and it was described that NOAEL was 3.70 mg/L (SIDS (2006)).
The hazard assessment of this substance in SIDS was conducted with a result of a test in which rats or mice were exposed by inhalation to methyl isobutyl ketone (MIBK; CAS RN: 108-10-1), one metabolite of this substance, for 14 weeks and along with a result of a combined repeated dose toxicity study with a reproduction/developmental toxicity screening test in which rats were dosed by gavage to 4-Hydroxy-4-methyl-2-pentanone (HMP; CAS RN: 123-42-2), another metabolite, for about 45 days. That is, in the 14-week inhalation exposure test to MIBK with rats or mice, none of them showed clear toxicity findings up to the highest concentration, and NOAEL was estimated as 4.09 mg/L. On the other hand, in the oral administration test of HMP with rats, at 300 mg/kg/day (converted guidance value: 150 mg/kg/day) corresponding to "Not classified," clinical symptoms (decreased locomotor activity, decreased stimulation response) and effects on the kidney (dilatation of the distal tubules, fatty degeneration of the proximal tubular epithelium) were observed. However, at or lower than this dose, only increased hyaline droplets in the tubular epithelium due to alpha-2u-globulin accumulation were observed in males (SIDS (2006)). Therefore, based on the toxicity test results of this substance and the 2 metabolites, SIDS concluded that repeated dose toxicity of this substance would be minimal (SIDS (2006)). And based on these test results including the 2 metabolites, US EPA also judged that there were no specific target organs that should be a concern, and that the toxicity of this substance was considered to be low (HPV-IS (2008)).
As in the above, although it was considered to be generally corresponding to "Not classified" by the inhalation route in experimental animals, hazardous findings in humans and long term test results, etc. by the oral route in experimental animals were lacking. Therefore, it was classified as "Classification not possible" due to lack of data.
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
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
-
-
- - It was classified as "Not classified" from 72-hour ErC50 = 334 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour EC50 = 337 mg/L for crustacea (Daphnia magna), and 96-hour LC50 = 359 mg/L for fish (Oncorhynchus mykiss) (all SIDS, 2006).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a 20-day degradation rate by DOC = 94% (SIDS, 2006)), and 72-hour NOEC = 75.5 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2006).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it corresponds to "Not classified" in acute toxicity for both crustacea and fish and is not water-insoluble (water solubility = 16400 mg/L (PHYSPROP Database, 2009)).
From the above results, it was classified as "Not classified."
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

To GHS Information