GHS Classification Result

Chemical Name:bis(hydroxylammonium) sulphate; hydroxylamine sulphate (2:1);
CAS:10039-54-0

Result:
ID: 20A2250
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not classified - - - - The substance has been classified into UNRTG Class 8, Packing Group III (2855).
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solid Not classified - - - - The substance has been classified into UNRTG Class 8, Packing Group III (2855).
8 Self-reactive substances and mixtures Type G - - - - The substance has been classified into UNRTG Class 8, Packing Group III (2855).
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Its autoignition point is 120degC (IUCLID (2000)), which is higher than 70degC.
11 Self-heating substances and mixtures Not classified - - - - The substance has been classified into UNRTG Class 8, Packing Group III (2855).
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 - - - - Solid (GHS definition)
14 Oxidizing solids Not classified - - - - Since the substance has no oxidizing property (IUCLID (2000)), it was classified into "Not classified".
15 Organic peroxides Not applicable - - - - Inorganic compound
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available. (melting point: >120degC (IUCLID, 2000))

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Since its rat LD50 values documented are > 500, 545, 568-725, and 642 mg/kg bw (IUCLID (2000)), and it is rated as Xn; R21/22 in the EU classification, the substance was classified into Category 4.
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 ...
The following LD50 values have been reported: > 200 and > 500 mg/kg bw for rats, and 100-500, 1500-2000, and > 400 mg/kg bw for rabbits (IUCLID (2000)). Among these documented values, two values (>500 mg/kg for rats and 1500-2000 mg/kg bw for rabbits) were obtained in GLP tests complying with OECD TG 402. Therefore, based on these two LD50 values, the substance was classified into Category 4.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - In the tests using rabbits that were treated with 80% aqueous solution for 20 hours, the substance was found to be irritating (severe to slight erythema was observed and they healed in 8 days). In addition, application of 40% aqueous solution for 20 hours caused irritation, while application of 25% aqueous solution for 20 hours caused no irritation (IUCLID (2000)). Based on these results, the substance was classified into "Not classified" with respect to the JIS classification criteria (Category 3 in the United Nations classification).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
In the tests using rabbits that were treated with 25% water solution (which is equivalent to application of 6 mg test substance) for 1 hour, slight irritation (erythema was seen for up to 24 hours) was observed, and application of 40% water solution also caused slight irritation (slight erythema and edema were seen and they healed after 24 to 48 hours) (IUCLID (2000)). In addition, application of 50 mg for 24 hours triggered severe irritation (slight erythema, severe edema and corneal opacity continued for 8 days) (IUCLID (2000)). Furthermore, the substance is rated as Xi; R36/38 in the EU classification. From this information, the substance was classified into Category 2A.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Positive reactions were found in both maximization and patch tests using guinea pigs (IUCLID (2000)). Also in several patch tests applied to humans, clear positive reactions were observed (IUCLID (2000)). It is rated as Xi; R43 in the EU classification and is documented as Sh in MAK/BAT. From this information, the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - Negative results were documented from the following tests: dominant lethal tests using mice that underwent intraperitoneal administration (in vivo heritable mutagenicity tests), cytogenetical tests using spermatogonia of mice that underwent intraperitoneal administration (in vivo mutagenicity tests using germ cells), and micronucleus tests using mice that underwent forced oral administration (in vivo mutagenicity tests using somatic cells) (IUCLID (2000)). Based on these negative results, the substance was classified into "Not classified". Also, Ames tests yielded negative results (NTP DB (accessed in December 2008) (IUCLID (2000)) while mouse lymphoma assays gave positive results (IUCLID (2000)).
6 Carcinogenicity Classification not possible - - - - In the tests using female C3H/HeN mice (provirus carriers) that underwent oral administration for 123-weeks through drinking water, there was no significant difference between treated and control groups in terms of development of hepatocellular carcinomas, lung adenomas, lymphomas and tumors of the ovary; however, increased vascular neoplasms of the spleen were observed in treated animals (IUCLID (2000)). In the tests using both sexes of C3H/HeJ (+) mice (virus carriers) that underwent oral administration for 105 weeks through drinking water, increased vascular neoplasms of the lymph node (hemangiomas) and lymphomas in males were observed (IUCLID (2000)). In life-long, mixed diet tests using both sexes of AKR (m), C3H (f) or Swiss (m) mice, a decrease in development of tumors was observed in C3H strain, while an increase in tumorigenesis was not detected (IUCLID (2000)). Since the increased tumorigenesis is discovered using datasets that involved provirus carrying mice, and there are no datasets using other animal species, the substance was classified into "Classification not possible".
7 Reproductive toxicity Classification not possible - - - - In developmental toxicity tests using rats that underwent forced oral administration during the organogenetic period (OECD TG-GLP), an increased weight of the spleen and hematotoxicity (hemolytic anemia) were observed in terms of the effects on maternal animals; however, in terms of the effects on offspring, no teratogenicity or birth defects were recognized (IUCLID (2000)). Overall, since there are no data available on reproductive functions and fertility in parental animals, classification is not possible.
8 Specific target organ toxicity - Single exposure Category 1 (blood), Category 2 (central nervous system) Danger
Warning
H370: Causes damage to organs (blood)
H371: May cause damage to organs (central nervous system)
P307+P311: IF exposed: 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.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
In oral administration tests using rats, slight cyanosis, apathy, atony and convulsions were observed at the dose of 370 mg/kg, which falls under Category 2 guidance doses. In other oral administration tests using rats, cyanosis was detected at 250 mg/kg, which falls under Category 1 guidance doses, and cyanosis, lachrymation and convulsions were observed at 2500 mg/kg, which falls under Category 2 guidance doses. In addition, in dermal administration tests using rabbits, cyanosis and splenomegaly were seen at >= 100 mg/kg, which falls under Category 1 guidance doses. And in other dermal administration tests using rabbits, cyanosis, hypothermia, reduction in red blood cell counts, increases in reticulocyte counts and splenomegaly were found at 500 mg/kg, which falls under Category 1 guidance doses (IUCLID (2000)). Based on these results, the substance was classified into Category 1 for blood, and Category 2 for the central nervous system.
9 Specific target organ toxicity - Repeated exposure Category 2 (hematopoietic system) Warning H373: May cause damage to organs through prolonged or repeated exposure (hematopoietic system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In 4-week oral administration tests through drinking water using rats that were treated with 25, 100, 400, or 1600 mg/L (conversion values: 2.25, 9, 36 or 144 mg/kg, respectively), hemolytic anemia and splenomegaly were detected at >= 36 mg/kg (90-day conversion: >= 12.48 mg/kg), which falls under Category 1 guidance doses. In 3-month oral administration tests through drinking water (doses: 10, 50 or 250 mg/L (conversion values: ca. 0.9, 4 or 21 mg/kg, respectively)), hemolytic anemia and splenomegaly were detected at 4 and 21 mg/kg, which fall under Category 1 guidance doses (IUCLID (2000)). Finally, in 3-week dermal administration tests using rabbits that were treated with 0.73, 1.47, 5.85 or 11.7 mg/kg, anemia was observed at 1.47 mg/kg (90-day conversion: 0.37 mg/kg), which falls under Category 1 guidance doses (IUCLID (2000)). These results indicate that the substance is to be rated as Category 1; however, since they are based on List 2 datasets, it was classified into Category 2 (hematopoietic system).
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) Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Since its 48h EC50 = 5.0 mg/L for crustaceans (Daphnia) (IUCLID 2000), the substance was classified into Category 2.
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Its classification for acute toxicity is Category 2 and it is assumed not to be rapidly degradable as it is an inorganic substance. However since its 96h EC0 = 5000 mg/L for algae (IUCLID 2000), the substance was classified into the "Not classified" category.


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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