GHS Classification Result

Chemical Name:N,N-Diethylhydroxylamine
CAS:3710-84-7

Result:
ID: 22A4153
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not classified - - - - Although it contains chemical groups (NO) associated with explosive properties in the molecule, the oxygen balance is lower than -200, therefore it was classified as "Not classified".
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: Flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Although measurement method of the flash point 45 degC (HSDB (2008)) is unknown, it is estimated that the flash point measured by the closed-cup method fall within the range of >= 23 degC and <= 60 degC. Therefore, the substance is classified into Category 3.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible - - - - It contains chemical groups (NO) associated with explosive properties in the molecule. Since no test results are available, classification is not possible.
9 Pyrophoric liquids Classification not possible - - - - No data available.
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 Classification not possible - - - - The substance is an organic compound containing oxygen which is chemically bonded to the elements other than carbon or hydrogen, but classification is not possible due to lack of additional data.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Based on the rat LD50 value of 2190 mg/kg bw (US EPA/HPV Challenge program (2005)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification).
1 Acute toxicity (Dermal) Category 4 Warning H312: Harmful in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Based on the rat LD50 value of 1300 mg/kg bw (US EPA/HPV Challenge program (2005)), the substance was classified into Category 4.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 4 Warning H332: Harmful if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
Based on the rat LC50 value of 3140 ppmV/4hrs (EPA/OPP 81-3, GLP-compliant) (US EPA/HPV Challenge program (2005)), the substance was classified as Category 4. Since the LC50 value (3140 ppm) was higher than 90% of the saturated vapor pressure concentration (6579 ppm), the test substance was judged as "vapor hardly coexisting mist", and the criterion values for gas were adopted.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - The substance was classified as "Not classified" based on the documented case of "not irritating" resulted from the rabbit test (49 CFR 173.240) in which no signs of irritancy were evident in any of the six animals following 4-hour occlusive treatment of undiluted substance (US EPA/HPV Challenge program (2005)).
3 Serious eye damage/eye irritation Not classified - - - - In the rabbit test, instillation of 0.1 ml of undiluted substance to conjunctival sac caused no effect on cornea nor iris, and irritant reaction was limited to conjunctival redness without chemosis. All symptoms were reversible within 72 hours (US EPA/HPV Challenge program (2005)). Based on the document, the substance was classified as "Not classified".
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - In the guinea pig Buehler tests (EPA/OPP 81-6, GLP-compliant), no skin reaction was noted after 24 and 48 hours of elicitation in both test and control groups. Positive rate was both 0% (0/10 and 0/5, respectively). In the positive control group, all sites were erythemic and positive rate was 100% (10/10). Based on the results, the substance was evaluated as a non sensitizer (US EPA/HPV Challenge program(2005)). Thus, the substance was classified as "Not classified".
5 Germ cell mutagenicity Not classified - - - - The classification was concluded as "Not classified" based on the negative results in the micronucleus test using bone marrow obtained from mice orally administered (OECD TG474, GLP-compliant) (in vivo mutagenicity test in somatic cells) (US EPA/HPV Challenge program (2005)). As relevant information, negative results were reported in the unscheduled DNA synthesis assay using the liver of rats orally administered (OECD TG486, GLP-compliant) (in vivo mutagenicity test in somatic cells) (US EPA/HPV Challenge program (2005)). As for in vitro studies, negative results in the Ames test (US EPA/HPV Challenge program (2005)), positive results in the chromosome aberration test using CHO cells (NITE safety test, Access on Aug. 2010) were reported.
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Classification not possible - - - - In the oral administration study using pregnant rats during the organogenetic period (OECD TG 414, GLP-compliant), there were no adverse effects on the development of the offspring at the dose level causing general toxicity such as suppression of body weight gain and food consumption to maternal animal (US EPA/HPV Challenge program (2005)). However, since sufficient information was not provided regarding sexual functions and fertility of parental animals, the substance was classified as "Classification not possible".
8 Specific target organ toxicity - Single exposure Category 2 (nervous system) Warning H371: May cause damage to organs (nervous system) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ...
Clinical signs of toxicity such as muscle incoordination and depression of systemic function were reported in the acute oral toxicity study in rats (dose levels: 1400 - 4000 mg/kg, LD50 value: 2190 mg/kg), and hypersensitivity, mydriasis, and incoordination were also reported in the acute dermal toxicity study in rabbits (dose levels: 707 - 2000 mg/kg, LD50 value: 1300 mg/kg) (US EPA/HPV Challenge program (2005)). Moreover, signs containing lethargy and tremors observed in mice treated at 1500 mg/kg were described in the micronucleus assay (OECD TG 474, GLP-compliant), and ones containing piloerection, lethargy, and tremors in rats treated at 2000 mg/kg were described in the UDS assay using rats (OECD TG 486, GLP-compliant) (US EPA/HPV Challenge program (2005)). Based on the clinical symptoms as described above, because these were all observed at the doses equivalent to Category 2 of the guidance values, the substance was classified as Category 2 (nervous system).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In the 28-day repeated dose oral toxicity study in rats (OECD TG 407, GLP-compliant), no toxic effects were reported except for clinical signs containing salivation, reddish eye discharge, reddish nasal discharge, and reddish urine at the high dose group of 500 mg/kg/day (converted dose level as that of 90-day study: 155.5 mg/kg/day) (NITE Toxicity and Eco-toxicity Test Results (Access on Aug. 2010)). Based on this, the classification of the substance was judged to be equivalent to "Not classified" category for oral route. While, in the 28-day repeated inhalation toxicity study in rats (Directive 84/449/EEC, B.8 "Sub-acute toxicity (inhalation)", GLP-compliant), clinical signs, changes in percentage of the differential leukocyte count, various changes in serum biochemical parameters, medullary plasmacytosis in the iliac and popliteal lymph nodes were noted in males in the high dose group at 1500 ppm (converted dose level as that of 90-day study: 5.47 mg/L). The effects in the 150 ppm group (converted dose level as that of 90-day study: 0.547 mg/L) were limited to slight decreases in albumin and A/G ratio in females only (US EPA/HPV Challenge program (2005)). However, since the effects near the upper limit of the guidance values (1 mg/L) were unknown, the classification was not possible for inhalation route. Further, no data were available for dermal route. Based on the findings described above, the classification for specific target organ toxicity (repeated exposure) was concluded as "Classification not possible". In addition, in the inhalation study, state of the exposure was regarded as vapors because the test concentrations (15 - 1500 ppm) were below the saturated vapor pressure concentration (6579 ppm).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Not classified - - - - Classified as "Not classified" from its 48h-EC50 = 110.56 mg/L for crustacea (Daphnia magna) (HSDB, 2008).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility: 89000 mg/L (PHYSPROP Database, 2011)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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