GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 109-73-9 |
| Chemical Name | n-Butylamine |
| Substance ID | H29-B-119 |
| Classification year (FY) | FY2017 |
| 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) | |
| 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 2 |
 Danger |
H225 |
P303+P361+P353
P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Based on a flash point of -12 deg C (closed cup), and a boiling point of 78 deg C (ICSC (J) (2003)), it was classified in Category 2. Besides, it is classified in Class 3, Subsidiary risk 8, PGII in UNRTDG (UN 1125). |
| 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 310 deg C (GESTIS (Access on September 2017)). |
| 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 |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine |
| 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) | Category 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
Based on a report of an LD50 value of 372 mg/kg (SIDS (2016), ACGIH (7th, 2001), PATTY (6th, 2012)) for rats, this substance was classified in Category 4. The category was changed from the previous classification by use of a new information source. |
| 1 | Acute toxicity (Dermal) | Category 3 |
 Danger |
H311 |
P302+P352
P361+P364 P280 P312 P321 P405 P501 |
There are reports of LD50 values of 850 mg/kg (OEL Documentations (Japan Society For Occupational Health, 1994)) and > 1,100 mg/kg (SIDS (2016)) for rabbits. One value corresponds to Category 3, and another value corresponds to Category 4 or "Not classified." It was classified in Category 3 by adopting the category with higher hazard. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 3 |
Danger |
H331 |
P304+P340
P403+P233 P261 P271 P311 P321 P405 P501 |
There are reports that LC50 values in 4-hour inhalation exposure tests with rats were 4.2 mg/L (1,403 ppm) and > 4.6 mg/L (> 1,536 ppm) (both in SIDS (2016)). One value corresponds to Category 3, and another value corresponds to Category 3 or greater than Category 3. It was classified in Category 3 by adopting the category with higher hazard. The classification result was changed from the previous classification by use of a new information source. Besides, since the LC50 values were lower than 90% of the saturated vapour pressure concentration (122,610 ppm), a reference value in the unit of ppm was applied as vapour with little mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Category 1 |
 Danger |
H314 |
P301+P330+P331
P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501 |
There is a description that in a skin irritation test with guinea pigs, necrosis occurred after application (OEL Documentations (Japan Society For Occupational Health, 1994)). There is a description that in a skin irritation test (equivalent to OECD TG 404) with rabbits, in exposure time of 1 minute, immediate necrosis occurred, eschar was produced, and it showed corrosivity (SIDS(2016)). Therefore, this substance was classified in Category 1. Besides, this substance was classified as "Skin Corr.1A, H314" in the EU CLP classification (ECHA CL Inventory (Access on August 2017)). |
| 3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 |
P305+P351+P338
P280 P310 |
It was classified in Category 1 for skin corrosion/irritation. There are descriptions that the highest damage (9 on a scale of 1 to 10) was observed in the eyes of rabbits (OEL Documentations (Japan Society For Occupational Health, 1994)), and that in an eye irritation test with rabbits, damages of the cornea and iris did not resolve in 24 days, and it showed corrosivity (SIDS (2016)). Therefore, this substance was classified in Category 1. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | There is a description that in a skin sensitization test (OECD TG 406 compliant) with guinea pigs, no skin reaction was observed in all of 20 test animals both 24 and 48 hours after challenge, thus, sensitization was not seen. It is described that also in another test (EPA OTS 798.4100 compliant) with guinea pigs, no sensitization was observed (both in SIDS (2016)). Since the information on humans was not obtained, it was classified as "Classification not possible." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a micronucleus test with mouse bone marrow cells was negative (Risk Assessment Report (Additives) (Food Safety Commission of Japan, 2010)). As for in vitro, bacterial reverse mutation tests and a mammalian cell mouse lymphoma test were negative, and a mammalian cell chromosomal aberration test was positive (numerical aberration) (SIDS (2016), Risk Assessment Report (Additives) (Food Safety Commission of Japan, 2010), NTP DB (Access on September 2017)). From the above, this substance was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Category 1B |
 Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
There is no information on reproductive effects in humans. As for experimental animals, in a study with pregnant rats exposed by inhalation to the concentration of 50-450 mg/m3 of this substance on gestational day 6-19, in maternal animals, dose-dependent squamous metaplasia, inflammation, and hyperplasia of transitional epithelium in the anterior nasal cavity epithelium were observed at or above 50 mg/m3, in addition, necrosis of the nasal mucosa at 450 mg/m3 was observed, and other local irritation effects on the respiratory organs from the low concentration group were observed in dams, but systemic toxic effects were not observed in up to the highest concentration group. In addition, no developmental effects on fetus were detected at up to the highest concentration (SIDS (2016)). On the other hand, in a study with pregnant rats dosed by gavage at the doses of 100, 400, and 1,000 mg/kg/day (converted value equivalent to this substance: 66, 265, and 660 mg/kg/day) of hydrochloride salt of this substance on organogenesis period (gestational day 6-15), a decrease in body weight gain and food consumption, and low value of gravid uterine weight in maternal animals at 1,000 mg/kg/day, and in fetuses, cardiovascular system malformations and tail malformation at or above 400 mg/kg/day and a slight increase in embryo/fetus deaths at 1,000 mg/kg/day were observed (SIDS (2016), Risk Assessment Report (Additives) (Food Safety Commission of Japan, 2010)). As the above, no developmental effects were observed in the developmental toxicity study by the inhalation route, but in the oral route test, teratogenicity was observed from the dose lower than those where maternal toxicity was manifested. Therefore, it was classified in Category 1B for this hazard class according to the GHS classification guidance for the Japanese government. Besides, in this review, the classification became possible by using a new information source that was available after the previous classification. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (respiratory organs), Category 2 (central nervous system) |
Danger Warning |
H370
H371 |
P308+P311
P260 P264 P270 P321 P405 P501 |
In humans, there is a description that the basic action of this substance at high concentration is severe burns of the skin and the eyes, and irritation of the respiratory organs, and it leads to pulmonary edema in severe case (OEL Documentations (Japan Society For Occupational Health, 1994), ACGIH (7th, 2001)). In addition, there is a description that humans daily exposed to 5-10 ppm of this substance experience the irritation of the nose, throat, and eye, complain of headache, at 10-25 ppm, and they are unpleasant, and intolerable for exposure of more than a few minutes (OEL Documentations (Japan Society For Occupational Health, 1994), PATTY (6th, 2012)). As for experimental animals, there is a report that in a single oral dose test with rats, sedation, ataxia, salivation, nasal discharge, and gasping were observed at or above 100 mg/kg corresponding to Category 1, and convulsion was observed at high doses (SIDS (2016)). Although there is no description of the minimum dose where convulsion was observed, it was considered that it was observed within the range for the Category 2 since the maximum dose in this test was 600 mg/kg within the range for the Category 2. In inhalation route, there is a report that in a 4-hour inhalation exposure test with rats, eyelid closure, dyspnea, apathy, corneal opacity, crouching position and staggering gait were observed at or above 3.1 mg/L corresponding to Category 1 (SIDS (2016)). In addition, there is a report that in another 4-hour inhalation exposure test with rats, no mortality was observed, but abnormal respiration, sneezing, rales, gasping, brown stained nose, nasal discharge, and corneal opacity were observed, and at necropsy, congestion in the lungs was observed in one animal out of 10 in addition to the observation of partial red or gray discoloration in the lungs (SIDS (2016)). From these results, the Japan Society For Occupational Health states that the main action of this substance is irritation to the skin and mucosa, and that it is also recognized to act on the central nervous system by large amount dose to animals (OEL Documentations (Japan Society For Occupational Health (JSOH), 1994)). Together with the above information on human and experimental animals, this substance was classified in Category 1 (respiratory organs), Category 2 (central nervous system). The classification result was changed from the previous classification by use of a new information source. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, there is a report that in a 90-day repeated oral dose toxicity study with rats, no effects were observed even at the highest dose of 18 mg/kg/day (Risk Assessment Report (Additives) (Food Safety Commission of Japan, 2010)). However, since the dose is considerably lower than the upper limit of the guidance value for Category 2, it cannot be classified based on this data. In addition, there is a possibility of effects on the respiratory organs since this substance causes acute irritation of the respiratory organs. However, as for HSFS which is the information source for classification evidence of Category 1 (respiratory organs) in the previous classification, since it is the information source in List 3, it was not used for the classification. Therefore, the classification result was different from the previous one. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 0.78 mm2/sec (25 deg C) from the numerical data (viscosity: 0.574 mPa*s (25 deg C), density (specific gravity): 0.7327 (25/4 deg C)) listed on HSDB (Access on August 2017). |
| 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 96-hour LC50 = 24 mg/L for fish (Menidia beryllina) (NLM HSDB: 2014, EPA AQUIRE: 2017), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Chronic toxicity data were not obtained. Due to being rapidly degradable (readily biodegradable, a degradation rate by BOD: 66% (reference value), a degradation rate by HPLC: 100% (J-CHECK, 1979)), no bioaccumulation (LogKow: 0.97 (SRC PhysProp Database: 2017)), it was classified as "Not classified." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |