GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 7758-98-7
Chemical Name Copper(II) sulfate (anhydrous)
Substance ID H29-B-033
Classification year (FY) FY2017
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 FY2006  
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

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
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 solids Not classified
-
-
- - It is not combustible (ICSC (J) (2001)).
8 Self-reactive substances and mixtures Not classified
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- - Solid (GHS definition).
10 Pyrophoric solids Not classified
-
-
- - It is not combustible (ICSC (J) (2001)).
11 Self-heating substances and mixtures Not classified
-
-
- - It is not combustible (ICSC (J) (2001)).
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- - It is estimated that it does not react vigorously with water from the measurement result of water solubility of 20.3 g/100 mL (20 deg C) (ICSC (J) (2001)).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- - It is an inorganic compound containing oxygen, but the classification is not possible due to no data.
15 Organic peroxides Not applicable
-
-
- - It is an inorganic compound.
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
Based on an LD50 value of 300 mg/kg for rats (EHC 200 (1998)), this substance was classified in Category 3.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 1


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
There are reports on the strong irritation and corrosivity in humans (HSDB (Access, June 2017)) and reports that it is markedly irritating to the skin and causes redness and pain (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). From these results, this substance was classified in Category 1. Besides, this substance is classified as "Skin Irrit. 2" in the EU CLP classification (ECHA CL Inventory (Access on June 2017)).
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
In humans, it is indicated to be a strong irritant causing conjunctivitis, edema of the eyelids, ulceration, corneal opacity, etc. (HSDB (Access on June 2017)) and causing redness and pain (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). Since there are reports of corrosivity in skin irritation (HSDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)), this substance was classified in Category 1. Besides, in the EU CLP classification, this substance is classified as "Eye Irrit. 2" (ECHA CL Inventory (Access on June 2017)).
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
In humans, there are many reports suggesting that skin sensitization occurred when a 0.5-5.0% aqueous solution or petrolatum-containing mix of this substance was applied for 24-48 hours in patch tests (EHC 200 (1998)). Also copper and its compounds are classified in occupational skin sensitizers Group 2 by Japan Society for Occupational Health (JSOH). Therefore, this substance was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, this substance showed positive and negative results in micronucleus tests with mouse bone marrow cells, and positive in a chromosome aberration test with mouse bone marrow cells (ATSDR (2004)), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015). However, the positive results of the in-vivo micronucleus test and chromosomal aberration test were done by intraperitoneal administration. As for in vitro, bacterial reverse mutation tests gave negative results (ATSDR (2004), SIAP (2014)). In SIAP (2014), based on the negative findings on the pentahydrate of this substance in in-vivo micronucleus tests with mice and an in vivo unscheduled DNA synthesis test with rats, it was evaluated that "Copper and copper compounds are not genotoxic." From the above, this substance was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.
6 Carcinogenicity Classification not possible
-
-
- - There is no epidemiological report available for evaluation regarding the carcinogenicity of copper compounds (DFGOT Vol. 22 (2006)). In carcinogenicity-related studies with experimental animals, there is no evidence that copper or inorganic copper compounds are carcinogenic. However, it is considered that there are no test reports that can draw conclusions because of reasons such as the short test period, the small number of animals used, the narrowness of the range of histopathological examinations, and insufficient description in any of the reports (EHC 200 (1998), DFGOT Vol. 22 (2006)).
Therefore, classification was not possible due to lack of data.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
There are no data on this substance itself (anhydrate), but there are data of its hydrate. In a developmental toxicity test in which copper sulfate pentahydrate (CAS RN 7758-99-8) was given by feeding to two strains of female mice (C57BL, DBA) from one month before mating to day 19 of pregnancy, at or more than 123 mg Cu/kg/day, an increased number of dead fetuses (C57BL), decreased litter size (both strains), and the low incidence (1.8 to 8.9%) of malformations (hydrocephalus, encephalocele, skeletal abnormality: both strains) was observed (DFGOT Vol. 22 (2006), EHC 200 (1998)). Although there is no description on maternal toxicity, it was considered to be a dose highly likely to cause maternal toxicity from results of subchronic and chronic toxicity tests (DFGOT Vol. 22 (2006)). As described above, because in the test on mice using the pentahydrate, developmental effects including malformations were observed at a dose highly likely to cause maternal toxicity, this substance was classified in Category 2.
8 Specific target organ toxicity - Single exposure Category 1 (nervous system, haemal system, liver, kidney), Category 3 (respiratory tract irritation)



Danger
Warning
H370
H335
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
In humans, multiple cases are reported where in a single oral intake in a suicide attempt or accidental ingestion of this substance, nausea, vomiting, upper abdominal pain, diarrhea, hematemesis or melena, reduced blood pressure, delirium, coma, jaundice, intravascular hemolysis, oliguria, and anuria were caused. In addition, multiple cases were reported in which centrilobular necrosis and biliary stasis in the liver, and renal glomerular congestion and detachment of renal tubule cells in the kidney were observed (ATSDR (2004), HSDB (Access on June 2017)). As for inhalation exposure, although it is not this substance, there is a description that the inhalation of fine particulate dust containing copper oxide (II) (CAS RN 1317-38-0) and copper acetate (II) (CAS RN 142-71-2) may cause sneezing, coughing, disorders of the digestive system and fever (DFGOT vol. 22 (2006)). As for experimental animals, it is reported that acute toxicity symptoms due to single oral intake of copper compounds including this substance are salivation, vomiting, diarrhea, gastric hemorrhage, increased heart rate, hypotension, hemolytic anemia, convulsions, and paralysis etc. (EHC 200 (1998), DFGOT Vol. 22 (2006)). Although there is no detailed description of the dose at which these effects were observed, assuming that they were observed around the LD50 value, since the LD50 value for rats was reported as 300 mg/kg, it is considered to be in the near upper limit of the range of Category 1 (EHC 200 (1998)). In addition, there is a report that in a single exposure test in which guinea pigs were exposed by inhalation to the aerosol of this substance, decreased cilia movement in the respiratory tract was observed (ATSDR (2004)).
Together with the above information, it is considered that this substance has effects on the nervous system, haemal system, liver, kidneys and gastrointestinal tract and also causes respiratory tract irritation. Among these, the effects on the gastrointestinal tract were excluded from the target organs because this was considered to be due to irritation from this substance. Therefore, this substance was classified in Category 1 (nervous system, haemal system, liver, kidney), Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs), Category 2 (liver)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
As for humans, there is a report that an occupational disease called "vineyard sprayer's lung" was seen in vineyard workers spraying antifungal agents containing 1-2.5% of copper sulfate neutralized with slaked lime, and findings similar to silicosis were observed, and as common findings from alveolar lavage and biopsy, intraalveolar desquamation of macrophages, histiocytic and noncaseating granulomas containing inclusions of copper, and restorative lesions in the form of fibrohyaline nodules were included (ATSDR (2004)). In addition, there was also a report that in a case of a debilitated child with severe burns, in whom copper sulfate crystals were applied to the granulation tissue, hemolytic anemia was observed, and an increase in copper content in the serum and urine was observed (ATSDR (2004)).
There is a report that in a 92-day repeated oral toxicity study with rats dosed by feeding, at or above 2,000 mg/kg diet (34 mg Cu/kg/day: 85.4 mg/kg/day as copper sulfate anhydrate), which is within the guidance value range for Category 2, hyperplasia of the limiting ridge and hyperkeratosis of the forestomach, and hepatic inflammation were observed (EHC 200 (1998), DFGOT vol. 22 (2006)).
From the above, although there are effects on the respiratory and haemal systems in humans, since the number of case for the haemal system was only one, it was not adopted as evidence of classification. In addition, since the findings on the forestomach in experimental animals are considered to be due to the irritation, they were not adopted as evidence of classification.
Therefore, this substance was classified in Category 1 (respiratory organs), Category 2 (liver).
The classification results were changed from the previous classification because new information sources were used, and the observed effects were reexamined, etc.
10 Aspiration hazard Classification not possible
-
-
- - 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 (Acute) Category 1


Warning
H400 P273
P391
P501
From 96-hour LC50 = 0.006 [converted value 0.00258 mgCu/L] for fish (Thymallus arcticus) (WHO EHC: 1998), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1


Warning
H410 P273
P391
P501
Although the behavior of a metal salt in water is unknown, metal is regarded to be non-biodegradable due to an element, and water solubility is 220,000 mg/L, and 72-hour NOEC (growth inhibition) is 0.013 mg/L [converted value 0.005 mgCu/L] for algae (Chlamydomonas reinhardtii). Therefore, it was classified in Category 1.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


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.

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