NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	10039-54-0
Chemical Name	bis(hydroxylammonium) sulphate; hydroxylamine sulphate (2:1);
Substance ID	m-nite-10039-54-0_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified	- -	-	-	The substance has been classified into UNRTG Class 8, Packing Group III (2855).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified	- -	-	-	The substance has been classified into UNRTG Class 8, Packing Group III (2855).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Type G	- -	-	-	The substance has been classified into UNRTG Class 8, Packing Group III (2855).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Its autoignition point is 120degC (IUCLID (2000)), which is higher than 70degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Not classified	- -	-	-	The substance has been classified into UNRTG Class 8, Packing Group III (2855).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified	- -	-	-	Since the substance has no oxidizing property (IUCLID (2000)), it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available. (melting point: >120degC (IUCLID, 2000))	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), an increase of malignant tumors was observed in one species of animals and in one sex (rat, male) in a single study. Therefore, the finding was judged as limited evidence and this substance was classified in Category 2. Based on a new evaluation, the classification result was changed. [Evidence Data] (1) In a two-year combined chronic toxicity/carcinogenicity study (OECD TG 453) with rats dosed by drinking water, an increased incidence of hemangiosarcomas in males and hemangioma development in females, both in the spleen, was observed. It was reported that the increased incidence of these tumors was related to the treatment of this substance because the incidence of the tumors exceeded the upper limit of the historical control data, the tumors developed earlier in treated animals than in controls, and there was precursor lesion (angiomatous hyperplasia) (EU risk assessment (2008), OECD SIDS draft (INITIAL ASSESSMENT PROFILE) (SIAP, 2008), REACH registration dossier (Accessed Jan. 2021)). [Reference Data, etc.] (2) As for the classification results by domestic and international organizations, the EU classified this substance in Carc. 1B (EU-CLP Classification Results (Accessed Jan. 2022)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (blood), Category 2 (central nervous system)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 2 (hematopoietic system)	Warning	H373	P260 P314 P501	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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 2	- -	H401	P273 P501	Since its 48h EC50 = 5.0 mg/L for crustaceans (Daphnia) (IUCLID 2000), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

To GHS Information