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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	1303-00-0
Chemical Name	Gallium arsenide
Substance ID	R01-A-007
Classification year (FY)	FY2019
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
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)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on May 2019)).
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on May 2019)).
11	Self-heating substances and mixtures	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on May 2019)).
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Inorganic substance containing no oxygen or halogen. It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Inorganic substance. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 10,000 mg/kg (REACH registration dossier (Access on July 2019)) (2) LD50 for rats: > 15,000 mg/kg (HSDB (Access on June 2019))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 10,000 mg/kg (REACH registration dossier (Access on July 2019))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Category 1 was denied based on (1), and since other detailed data on this substance could not be confirmed, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) In an in vitro skin corrosive test (OECD draft guideline) using an artificial skin model (EpiSkin), the relative cell viability was 100.5% after 15 minutes of incubation, and it was judged to be non-irritant (REACH registration dossier (Access on July 2019)). (2) Direct dermal contact with inorganic arsenicals might cause irritation and contact dermatitis. Usually, the effects are mild (erythema and swelling), but they may progress to papules, vesicles, or necrotic lesions in extreme cases (ATSDR (1997)).
3	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In an eye irritation test (OECD TG 405, GLP) with rabbits (n= 3, male), the mean scores for the cornea, iris and conjunctiva at 24, 48, and 72 hours after application were all 0 (REACH registration dossier (Access on July 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), since the results of all standard combination tests, including in vivo and in vitro tests, were negative, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, there was a report of a negative result in a micronucleus test with mouse peripheral blood erythrocytes (NTP TR492 (2000), ACGIH (7th, 2005), IARC 86 (2006), IARC 100C (2012), PATTY (6th, 2012), NTP DB (Access on June 2019)). (2) As for in vitro, there were reports of negative results in a micronucleus test with cultured mammalian cells and a bacterial reverse mutation test (NTP TR492 (2000), ACGIH (7th, 2005), IARC 86 (2006), IARC 100C (2012), PATTY (6th, 2012), NTP DB (Access on June 2019)).
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), according to the priority order of cases where there are multiple data in the GHS classification guidance for the Japanese government, it was classified in Category 1A by using the classification result by IARC as the classification basis. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 1 by IARC (carcinogenic to humans) (IARC 86 (2006)), and Carc.1B in the EU CLP (EU CLP classification (Access on June 2019)). [Reference Data, etc.] (2) It was concluded in the evaluation by IARC that there was no evidence of carcinogenicity for this substance itself in humans and that the evidence in experimental animals was also limited. However, this substance was classified in Group 1 based on the following rationale. Once in the body, this substance released a small amount of its arsenic, which behaved as inorganic arsenic (Arsenic and arsenic compounds had been evaluated as IARC Group 1, carcinogenic to humans). It was pointed out that the simultaneously released gallium moiety might be responsible for lung cancer observed in female rats (IARC 86 (2006)). (3) In a carcinogenicity study in which rats were exposed by inhalation to this substance (0.01, 0.1, 1.0 mg/m3) for 2 years, no incidences of exposure-related tumors were observed in males. In females, an increased incidence of alveolar/bronchiolar adenoma, an increased combined incidence of alveolar/bronchiolar adenoma and carcinoma, an increased incidence of benign pheochromocytoma in the adrenal medulla, and increased mononuclear cell leukemia were observed at 1.0 mg/m3. Therefore, it was concluded that there was no evidence of carcinogenic activity in male rats and there was clear evidence of carcinogenic activity in female rats (NTP TR492 (2000)). (4) In a carcinogenicity study in which mice were exposed by inhalation to this substance (0.1, 0.5, 1.0 mg/m3) for 2 years, as no incidences of exposure-related tumors were observed in either males or females, it was concluded that there was no evidence of carcinogenic activity in male or female mice (NTP TR492 (2000), IARC 86 (2006)).
7	Reproductive toxicity	Category 1A	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), since it was considered that there was a reproductive effect in humans due to the effect of arsenic released and produced in the body, it was classified in Category 1A. Besides, as shown in (3)-(6), only data on the inhalation route in experimental animals were obtained for this substance, there were effects on spermatogenesis, and effects on the fetuses were observed at doses where maternal toxicity was observed. [Evidence Data] (1) This substance dissociated into gallium and arsenic in the mammalian lung and gastrointestinal tract, and the latter metabolically behaved as an inorganic arsenic compound (NTP TR492 (2000)). (2) Arsenic and arsenic compounds were classified in reproductive toxicants Group 1 (substances known to cause reproductive toxicity in humans) in the OEL Documentations (Japan Society For Occupational Health (JSOH), 2013). (3) In a test in which female rats were exposed by inhalation on gestational Days 4-19, reduced fetal body weight and increased skeletal variations were observed at concentrations where maternal toxicity (signs of pulmonary toxicity) was observed (NTP TER8914&TER90043 Abst (Access on June 2019), ACGIH (7th, 2005)). (4) In a test in which female mice were exposed by inhalation on gestational Days 4-17, embryolethality, fetal growth retardation, and a significant increase in fetal variations, and a tendency to increase the incidence of fetal variations were observed at the dose where deaths (mortality 50%) and pulmonary toxicity were observed in maternal animals (NTP TER8914&TER90043 Abst (Access on June 2019), ACGIH (7th, 2005)). (5) In tests in which rats and mice were exposed by inhalation for 14 weeks, testicular atrophy, decreased spermatid count, etc. were reported (NTP TR492 (2000), ACGIH (7th, 2005)). (6) In a test on testicular toxicity in which male rats were administered intratracheally twice a week for 8 weeks, spermatogenic failure due to disturbance of the spermatid head transformation at the late spermiogenic phases was reported (ACGIH (7th, 2005)). [Reference Data, etc.] (7) It was reported that as a result of investigation into the relationship between arsenic pesticide manufacturing plants and stillbirths in the United States, a significant increase in risk was observed in the high concentration group (OEL Documentations (Japan Society For Occupational Health (JSOH), 2013)). (8) There were multiple reports on reproductive toxicity due to oral exposure to arsenic-contaminated drinking water, and an increase in the incidence of miscarriages, stillborn, etc. due to ingestion during pregnancy was reported (OEL Documentations (Japan Society For Occupational Health (JSOH), 2013)). (9) It was classified in Repr.1B in the EU CLP (EU CLP classification (Access on June 2019)).
8	Specific target organ toxicity - Single exposure	Category 1 (blood system, immune system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There are no reports on a single exposure to this substance in humans. Based on the information of (1)-(4) in experimental animals, it was classified in Category 1 (blood system, immune system). [Evidence Data] (1) In a single oral dose test with rats, inhibition of activity in the blood of delta-aminolevulinic acid dehydrogenase (ALAD), which was a heme synthetase, and increases in urinary delta-aminolevulinic acid (ALA) concentration were observed at or above 100 mg/kg (equivalent to Category 1) (CLH Report (2009)). (2) In an in vitro test with either blood, liver tissue, or kidney tissue, gallium nitrate (CAS RN 13494-90-1) produced 50% inhibition of ALAD activity at 40-200-fold lower concentrations than those required by sodium arsenite (CAS RN 7784-46-5). In addition, in a single intraperitoneal dose test with rats using gallium sulfate (CAS RN 13494-91-2), dose-dependent inhibition of ALAD in the liver, kidney, and erythrocyte was observed at up to 200 mg/kg. From the above results, it was considered that the inhibition of ALAD activity by administration of this substance in vivo was mainly due to gallium (NTP TR492 (2000)). (3) In a single oral dose study with rats (same study as (1)), significant reductions in relative spleen weight, spleen cellularity, humoral immunity response, and cell-mediated immune response were observed at or above 100 mg/kg (equivalent to Category 1) (PATTY (6th, 2012), CLH Report (2009), ATSDR (2007)). (4) Gallium compounds (primarily gallium nitrate and gallium sulfate) were reported to have immunosuppressive effects in many in vitro and in vivo tests (NTP TR492 (2000), original source: Bernstein, L.R., Am. Soc. Pharmacol. Exp. There. 50, 665-682 (1998)). [Reference Data, etc.] (5) In a single oral dose test with rats (same study as (1) and (2)), increased blood AST activity at or above 100 mg/kg, increased hepatic malondialdehyde level, decreased hepatic glutathione content, and increased urinary protein level at or above 200 mg/kg were observed (PATTY (6th, 2012), ATSDR (2007)). In addition, in another single oral dose test with rats, increased blood pressure and heart rate, and decreased respiratory rate were observed at 2,000 mg/kg (CLH Report (2009), ATSDR (2007)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs, blood system, reproductive organs (male))	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), in inhalation exposure to experimental animals, effects on the respiratory organs, blood system, and testis were observed within the range of Category 1, therefore, it was classified in Category 1 (respiratory organs, blood system, reproductive organs (men)). [Evidence Data] (1) In a test in which rats were exposed by inhalation to the particulate aerosol of this substance at 0.1-75 mg/m3 for 14 weeks (6 hours/day, 5 days/week), decreased leukocyte count, alveolar proteinosis, etc. at or above 0.1 mg/m3 (converted guidance value: 0.0001 mg/L, within the range of Category 1), decreased hematocrit value, increased reticulocyte counts, microcytic responsive anemia with an erythrocytosis, increased platelet count, reduced spermatozoa motility at or above 10 mg/m3 (converted guidance value: 0.0078 mg/L, within the range of Category 1), decreased hemoglobin, increased zinc protoporphyrin/heme ratios, squamous metaplasia in the larynx, bone marrow hyperplasia (male), epididymal hypospermia at or above 37 mg/m3 (converted guidance value: 0.029 mg/L, within the range of Category 2), and decreased spermatid count at 75 mg/m3 (converted guidance value: 0.058 mg/L, within the range of Category 2) were seen (NTP TR492 (2000), ACGIH (7th, 2005)). (2) In a test in which mice were exposed by inhalation to the particulate aerosol of this substance at 0.1-75 mg/m3 for 14 weeks (6 hours/day, 5 days/week), microcytic responsive anemia with erythrocytosis at or above 0.1 mg/m3 (converted guidance value: 0.0001 mg/L, within the range of Category 1), alveolar proteinosis, etc. at or above 1 mg/m3 (converted guidance value: 0.0008 mg/L, within the range of Category 1), increases in platelet count and leukocyte count, increased zinc protoporphyrin/heme ratios, suppurative inflammation in the lung, squamous metaplasia in the larynx, hyperplasia of the tracheobronchial lymph node, epididymal hypospermia, etc. at or above 10 mg/m3 (converted guidance value: 0.0078 mg/L, within the range of Category 1), deceases in hemoglobin and hematocrit value, increased reticulocyte counts, and decreased spermatid counts, etc. at or above 37 mg/m3 (converted guidance value: 0.029 mg/L, within the range of Category 2), and death (one female) and hypospermia at 75 mg/m3 (converted guidance value: 0.058 mg/L, within the range of Category 2) were observed (NTP TR492 (2000), ACGIH (7th, 2005)). [Reference Data, etc.] (3) In tests in which rats and mice were exposed by inhalation to the particulate aerosol of this substance at 1-150 mg/m3 for 16 days (6 hours/day, 5 days/week), alveolar proteinosis and squamous metaplasia in the larynx, etc. were observed at or above 1 or 10 mg/m3 (converted guidance value: 0.0002 or 0.002 mg/L, within the range of Category 1) (NTP TR492 (2000), ACGIH (7th, 2005)). (4) In a test in which inhalation exposure to the particle aerosol of this substance was given to rats at 0.01-1 mg/m3 (converted guidance value: 0.00001-0.001 mg/L, within the range of Category 1) and mice at 0.1-1 mg/m3 (converted guidance value: 0.0001-0.001 mg/L, within the range of Category 1) for 2 years (6 hours/day, 5 days/week), nonneoplastic lesions were seen in the nose, larynx, and lungs in rats, and the tracheobronchial lymph node and lung in mice (NTP TR492 (2000)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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.

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