GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 3710-84-7 |
| Chemical Name | N,N-Diethylhydroxylamine [diethylhydroxylamine] |
| Substance ID | H27-B-012/C-033B_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 | FY2010 |
| 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 classified |
- |
- | - | It contains a chemical group associated with explosive properties (NO), but due to an oxygen balance below -200 (-225), it was classified as "Not classified." |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 6 | Flammable liquids | Category 3 |
 Warning |
H226 | P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
From flash point data of 45 degrees C (method unknown) (GESTIS (Access on June 2015)), it is estimated that it corresponds to Category 3 in a prescribed test. |
| 7 | Flammable solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | Although it contains a chemical group associated with explosive properties (NO), the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No established test method suitable for liquid substances. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Classification not possible |
- |
- | - | It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (N), but the classification is not possible due to no data. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an organic compound that does not contain bivalent -O-O- structure in the molecule. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | From a reported LD50 value of 2,190 mg/kg for rats (ACGIH (7th, 2013)), it was classified as "Not classified" (Category 5 in UN GHS classification). |
| 1 | Acute toxicity (Dermal) | Category 4 |
 Warning |
H312 | P302+P352 P362+P364 P280 P312 P321 P501 |
From a reported LD50 value of 1,300 mg/kg for rabbits (ACGIH (7th, 2013)), it was classified in Category 4. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 4 |
Warning |
H332 | P304+P340 P261 P271 P312 |
From a reported LC50 value (4 hours) of 3,140 ppm for rats (ACGIH (7th, 2013)), it was classified in Category 4. Besides, a reference value in the unit of ppm was applied as vapour without mist because the LC50 value is lower than 90% of the saturated vapour pressure concentration (4,421 ppm). |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that in a test in which undiluted solution of this substance was applicated for 4 hours to rabbits (49 CFR 173.240), no clear signs showing irritation were observed in any animals (6) (US EPA/HPV Challenge program (2005)). Moreover, slight irritation (ACGIH (7th, 2001)) or no irritation (ACGIH (7th, 2013)) was reported for rabbits. Therefore, it was judged to be "Not classified." |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
It is reported in two reports from eye irritation tests using rabbits (Draize test) that as a result of applying 0.1 mL of undiluted solution of this substance into the conjunctival sac of rabbits, irritation was limited to conjunctival redness without edema which disappeared completely within 24 hours, and that moderate conjunctivitis was observed but resolved within 72 hours (US EPA/HPV Challenge program (2005), ACGIH (7th, 2001)). From the above results, it was classified in Category 2B. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Not classified |
- |
- | - | In a Buehler test using guinea pigs (EPA/OPP 81-6, GLP compliance), skin reaction was not observed in either a test group applied a 30% aqueous solution of this substance or a control group 24 and 48 hours after a challenge, and a positive rate was 0% for both groups (0/10 and 0/5 respectively). A positive control group showed erythema in all sites 24 and 48 hours after a challenge and a positive rate of 100% (10/10). Therefore, it was concluded that a 30% aqueous solution of this substance is not sensitizing (US EPA/HPV Challenge program (2005), HSDB (Access on June 2015), ACGIH (7th, 2013)). From the above results, it was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, a dominant lethal test in rats gave negative and "ambiguous" results. A micronucleus test using bone marrow cells of mice and rats was negative, and an unscheduled DNA synthesis test in the liver of mice and rats was negative (US EPA Challenge program (2005): ACGIH (7th, 2013)). As for in vitro, a bacterial reverse mutation test, was negative, and a gene mutation test, a chromosomal aberration test, and an unscheduled DNA synthesis test in cultured mammalian cells were positive (NITE Safety test (2009), US EPA Challenge program (2005), ACGIH (7th, 2013)). From the above, although positive results in vitro, because multiple in vivo test systems were negative, it was not judged that Category 2 is appropriate. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is written that in a test to detect promoter action in an oral route (drinking water) with this substance (initiated by benzo(a)pyrene), there is a possibility of promoter action because an increased incidence of stomach papilloma was observed in females (no increase in males) (ACGIH (7th, 2013)). |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a developmental toxicity test in pregnant rats in gavage administration during an organogenetic period (day 6-15 of gestation), developmental toxicity effects were not observed in fetuses even at the doses (393, 568 mg/kg/day) where maternal animals showed weight gain reduction and decreased food consumption. (ACGIH (7th, 2013), U.S. HPV Challenge Program Test Plan (2005)) However, as for fertility effects by this substance, there is only the information from the report of a three-generation test using mice in an inhalation route by combined exposure to nitroethane (ACGIH (7th, 2013)), and no other available data to classify this substance. The classification is not possible due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (central nervous system) |
 Warning |
H371 | P308+P311 P260 P264 P270 P405 P501 |
There is no human information. As for experimental animals, the following was observed: muscular incoordination and decreased movement in rats and mice in oral administration at 2,150 mg/kg (corresponding to dose above Category 2) (ACGIH (7th, 2013), US EPA/HPV Challenge program (2005)); piloerection and lethargy in a UDS test in rats in oral administration at 2,000 mg/kg (a dose corresponding to Category 2); lethargy and tremors in a micronucleus test in mice in oral administration at 1,500 mg/kg (a dose corresponding to Category 2) (US EPA/HPV Challenge program (2005)); hypoactivity in rats in inhalation exposure to 11.45 mg/L (a dose corresponding to Category 2); and hypersensitivity and incoordination in rabbits in dermal exposure to 1,300 mg/kg (a dose corresponding to Category 2) (ACGIH (7th, 2013), US EPA/HPV Challenge program (2005)). Because hypersensitivity and tremors were observed in the above signs, this substance has effects on the central nervous system. Therefore, it was classified in Category 2 (central nervous system). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | There is no human information. As for experimental animals, in a 28-day gavage administration toxicity test using rats (OECD TG 407, GLP), salivation, red eye discharge, red nasal discharge, and red urine were observed at 500 mg/kg/day (converted to a 90-day equivalent: 155.5 mg/kg/day). (NITE Safety Test (2009)) These findings were not effects to be the rationale for classification, and at the dose outside of a range of Category 2. In a 4-week inhalation exposure test using rats (84/449/EEC, B.8), abnormal general conditions accompanying irritation to the upper respiratory tract, dirt coat, eyelid closure, hyperactivity (transient and not a significant change in FOB), walking on tiptoes, hunched posture, weight gain reduction, decreased food consumption, a change in differential leukocyte count (increased segmented neutrophil, decreased lymphocytes), increases in ALP/inorganic phosphorus/bile acid/ALT, decreased absolute/relative thymus weight, increased absolute/relative liver weight, and medullary plasmacytosis in the iliac and popliteal lymph nodes were observed at 1,500 ppm (converted to a Guidance value equivalent: 1.21 mg/L) (US EPA Challenge program (2005), ACGIH (7th, 2013)). These findings were at the dose outside of a range of Category 2 but close to the upper limit (1.0 mg/L). Therefore, it was classified as "Classification not possible" due to lack of data. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is 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) | Not classified |
- |
- | - | From 48-hour EC50 = 110.56 mg/L for crustacea (Daphnia magna) (IUCLID, 2000; HSDB, 2008), 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 = 89000 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. |
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. |