GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 97-88-1 |
| Chemical Name | n-Butyl methacrylate |
| Substance ID | H27-B-18-METI/M-018B_P |
| Classification year (FY) | FY2015 |
| Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2007 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 50 deg C (closed cup) (ICSC (2009)), it was classified in Category 3. |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group associated with self-reactive properties (olefins) present in the molecule, but the classification is not possible due to no data. Besides, stabilized one is classified in class 3 (UN 2227) in UNRTDG, and does not correspond to hazard class with the highest precedence, self-reactive substances and mixtures, and is classified in Class G. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 290 deg C (ICSC (2009)). |
| 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 reports of LD50 values for rats of > 2,000 mg/kg (OECD TG 401) (SIDS (2009), ECETOC JACC (1997)), > 3,200 mg/kg (ECETOC JACC (1997)), 16,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012), ECETOC JACC (1997)), 17,900 mg/kg (SIDS (2009), ECETOC JACC (1997)), 18,020 mg/kg, 18,561 mg/kg (ECETOC JACC (1997)), 22,600 mg/kg (PATTY (6th, 2012)), 16,000-22,600 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), this substance was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on the reports of LD50 values for rabbits of > 2,000 mg/kg (OECD TG 402) (SIDS (2009), ECETOC JACC (1997)), 10,181 mg/kg (ECETOC JACC (1997)), 11.3 mL/kg (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)), 11,300 mg/kg (PATTY (6th, 2012)), 10,181-11,300 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), this substance 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. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | There is a report that a result of a 4-hour inhalation test (OECD TG 403) with rats was 29 mg/L as approximate lethal concentration (ALC value) (SIDS (2009)). In addition, it was reported that the LC50 values for rats were 19.7 mg/L (ECETOC JACC (1997)), 28.6 mg/L (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012), SIDS (2009)). Therefore, this substance was classified as "Not classified." Besides, since the LC50 values were higher than 90% of the saturated vapor pressure concentration (17.2 mg/L), a reference value in the unit of mg/L was applied as vapour mixed with mist. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | There is a report that in a skin irritation test (OECD TG404) with rabbits, as a result of a semi-occlusive application with 0.5 mL of this substance for 4 hours, no irritation was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) or the irritation was mild (SIDS (2009)). There are other multiple reports that in skin irritation tests with rabbits, as a result of a semi-occlusive application with this substance for 4 hours, the irritation observed was mild (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2009), ECETOC JACC (1997)). From the above, this substance was classified as "Not Classified" (Category 3 in UN GHS classification). Based on the report of the guideline-compliant test, the category was changed. Besides, this substance was classified as "Skin. Irrit. 2 H315" in the EU CLP classification (ECHA CL Inventory (Access on December 2015)). Since it was not possible to confirm the data based on the guidelines from 1981 onward described in the previous classification, it was not used for classification. |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | There are two reports that in eye irritation tests (OECD TG405) with rabbits, no irritation of the eyes by applying this substance was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2009)). There are other reports that slightly irritating and highly irritating were observed in eye irritation tests with rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2009), ECETOC JACC (1997)), however, the details of the test methods, etc. are unknown. From the above, this substance was classified as "Not classified" based on the guideline-compliant test. Besides, this substance was classified as "Eye. Irrit. 2 H319" in the EU CLP classification (ECHA CL Inventory (Access on December 2015)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | It is reported that a maximization test (OECD TG406) with guinea pigs was negative (SIDS (2009)). Also, there are other multiple negative reports of maximization tests with guinea pigs (SIDS (2009), ECETOC JACC (1997), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, there is a report of negative result from a Freund's Complete Adjuvant test (OECD TG406), and there are multiple reports of negative result from other Freund's Complete Adjuvant tests (SIDS (2009), ECETOC JACC (1997), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). On the other hand, although the details are unknown, there is a report that weak a positive reaction was observed in a Freund's Complete Adjuvant test with guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ECETOC JACC (1997)), and there is a report that in a standard skin sensitization test (details are unknown) with guinea pigs, weak sensitization was observed in one out of ten (ECETOC JACC (1997)). As for occupational exposure, there are multiple reports of positive results (6/243, 3/79, 1/542) in patch tests with this substance (SIDS (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). It was concluded in SIDS (2009) that as there is a possibility that it was caused by other alkyl methacrylates in the human cases, although the sensitization of this substance is equivocal, the short-chain methacrylate esters are weak skin sensitizers. In addition, it was concluded in ECETOC JACC (1997) that this substance shows weak positive sensitization. From the above, there are positive reports with unknown details though there are reports of negative results in two tests compliant with the test guidelines, and no sufficient information for the judgment of negative or positive was obtained. Therefore, this substance was classified as "Classification not possible." Because there is information of the tests compliant with the test guidelines and positive results with unknown details, the category was changed. Besides, this substance was classified as "Skin sens. 1 H317" in the EU CLP classification (ECHA CL Inventory (Access on December 2015)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | This substance was classified as "Classification not possible" since it is not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, a micronucleus test with mouse bone marrow cells was negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JECDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), SIDS (2009)). As for in vitro, bacterial reverse mutation tests and mammalian cell chromosome aberration tests were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JECDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), SIDS (2009)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats by the oral route, at 1,000 mg/kg/day where general toxicity (a decrease in weight gain, a decrease in food consumption, atrophy of the red pulp of the spleen, etc.) in parental animals was manifested, decreases in the numbers of corpora lutea and implantations (Implantation rate was unchanged) were observed in maternal animals, but no effects on the paternal fertility and offspring were observed (SIDS (2009), JECDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). In addition, it is reported that in a developmental toxicity test with pregnant female rats exposed to this substance by inhalation on Gestational Days 6-20, decreased weight gain at or above 300 ppm and decreased food consumption at 1,200 ppm were observed in maternal animals, and in fetuses, low values of body weight were observed in females of 600 ppm or above and males of 1,200 ppm, respectively, but no teratogenicity was observed (SIDS (2009), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). As above, in the preexisting findings of experimental animals, there is no evidence of clear developmental toxicity that should be adopted as evidence for the classification, and in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by the oral route, decreases in the number of corpus luteum and implantations were observed in females when the limit dose was administered. It was described that there was no abnormality in ovarian follicle formation from the results of histopathological examination and these findings were speculated to be some effect related to ovulation, but no effects on the delivery index, pregnancy period, or nursing condition were observed in maternal animals (JECDB (Access on November 2015)). Based on the description, it was judged that these findings were not at least those which should be adopted as evidence for the classification for reproductive effects. Because there is no available data for the classification other than this, it was classified as "classification not possible" for this hazard class due to lack of data. In the reclassification, the category was changed by revision of the GHS classification guidance for the Japanese Government or re-examination of the information sources. |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (Respiratory tract irritation) |
 Warning |
H335 | P304+P340 P403+P233 P261 P271 P312 P405 P501 |
This substance is irritating to the respiratory tract (ECETOC JACC (1997), HSDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012)). In humans, cough, shortness of breath, sore throat from inhalation exposure, and abdominal pain by oral ingestion were seen (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). As for experimental animals, there was no finding that can be used for classification. From the above, this substance was classified in Category 3 (respiratory tract irritation). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (spleen) |
 Warning |
H373 | P260 P314 P501 |
There is no data on humans. As for experimental animals, in a 14-day repeated oral dose test with rats, a decrease in the hematocrit value was observed in males at 500 mg/kg/day (converted guidance value: 77.8 mg/kg/day) within the range of Category 2, and in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats by gavage, a decrease in the absolute and relative spleen weight and atrophy of the red pulp due to decreased extramedullary hematopoiesis were observed in males at 100 mg/kg/day (converted guidance value: 48.9 mg/kg/day) within the range of Category 2 (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), JECDB (Access on November 2015)). In a 4-week inhalation toxicity test with rats, no effect was observed at doses within the range of Category 2 (Environmental Risk Assessment for Chemical Vol.11 (Ministry of the Environment, 2013)). As in the above, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, effects on the spleen were observed within the range of Category 2. Besides, since the findings observed in the 14-day test were not toxic enough to meet the classification criteria, they were not adopted as evidence for the classification. Therefore, this substance was classified in Category 2 (spleen). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 3.486 mm2/sec (21/20 deg C) from the numerical data (Viscosity: 3.116 mPa*s (21 deg C), density: 0.8936 g/cm3 (20 deg C)) listed on HSDB (Access on November 2015). |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 2 |
- |
H401 | P273 P501 |
From 96-hour LC50 = 5.57 mg/L for fish (Oryzias latipes) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), SIDS, 2009, Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013)), it was classified in Category 2. |
| 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 being rapidly degradable (a degradation rate by 28-day BOD = 88%, a degradation rate by GC = 100% (Official Bulletin of Ministry of International Trade and Industry, 1997)), and 21-day NOEC (reproduction) = 1.1 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), SIDS, 2009). 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" due to rapid degradability and a low bioaccumulation estimate (log Kow = 2.88 (PHYSPROP Database, 2009)) although 96-hour LC50 = 5.57 mg/L for fish (Oryzias latipes) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), SIDS, 2009, Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013)). From the above, 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. |