GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 1333-86-4
Chemical Name Carbon black
Substance ID H27-B-047/C-083B_P
Classification year (FY) FY2015
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 FY2009   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 Classification not possible
-
-
- - No data available.
8 Self-reactive substances and mixtures Not applicable
-
-
- - 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 estimated that it does not ignite at normal temperatures from an autoignition temperature of >= 500 deg C (ICSC (2010)).
11 Self-heating substances and mixtures Category 1-2 (animal or vegetable origin), Classification not possible (excludinig animal or vegetable origin)
-
-
- - Among those of animal or plant origin, there is one that is classified in Division 4.2, PG II, III (UN1361) in UNRTDG, corresponding to GHS Category 1 or 2.
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 applicable
-
-
- - Inorganic substance not containing oxygen or halogen
15 Organic peroxides Not applicable
-
-
- - It is inorganic substance.
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) Not classified
-
-
- - Based on LD50 values for rats of > 8,000 mg/kg and > 10,000 mg/kg (2 cases) (SIDS (2007)), it was classified as "Not classified."
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a report of an LD50 value of > 3,000 mg/kg for rabbits (RTECS (Access on August 2015), GESTIS (Access on August 2015)). However, since it was from the information source listed in List 3, and the original article could not be confirmed, it was not adopted for classification.
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 Not classified
-
-
- - There is a report that in a skin irritation test (OECD TG 404) with rabbits, irritation was not observed as a result of an occlusive application of 500 mg of this substance for 4 hours (SIDS (2007)). In addition, there is a report that in another skin irritation test with rabbits, irritation was not observed as a result of applying this substance (20-27%) (SIDS (2007)). From the above, it was classified as "Not classified."
3 Serious eye damage/eye irritation Not classified
-
-
- - There are three reports on eye irritation tests (OECD TG 405) with rabbits, and it is reported in all of them that no irritation by applying this substance (undiluted solution) was observed (SIDS (2007)). From the above, it was classified as "Not classified."
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, there are results of being positive in a gene mutation (hprt) test with rat alveolar cells by inhalation exposure and intratracheal instillation, and of being positive and negative in DNA adduct formation tests with rat lungs by inhalation exposure. However, it is pointed out that the positive results may be caused by aromatic polycyclic hydrocarbons contained in this substance or by the generation of active oxygen species associated with inflammation, and this is not considered to suggest mutagenicity of carbon black itself (IARC 93 (2010), DFGOT Vol. 18 (2002), SIDS (2007)). As for in vitro, it showed positive and negative results in bacterial reverse mutation tests, and it was positive in a micronucleus test with mammalian cultured cells, and negative in a mouse lymphoma test and a sister chromatid exchange test (IARC 93 (2010), SIDS (2007), DFGOT Vol. 18 (2002)). From the above, it is considered that this substance is not mutagenic by itself, and it was classified as "Classification not possible" according to the GHS classification guidance for the Japanese government.
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
As for humans, from cohort studies and nested case-control studies mainly in the United Kingdom, Germany, and the United States, there were some reports suggesting the relationship between occupational exposure to this substance and an excess risk of death by lung cancer. However, the results supporting the correlation between both were not obtained for the following reasons: the possibility of the effect of smoking could not be excluded; and a significant difference in excess risk of death by lung cancer disappeared as a result of correcting the effects of co-exposure to asbestos or talc and so on (IARC 93 (2010), ACGIH (7th, 2011)). Other than these, there are reports which suggested excessive risks for carcinogenicity of the urinary bladder, kidney, stomach, and esophagus, but it was described that neither of these reports was sufficient as evidence to support carcinogenicity of this substance in humans (IARC 93 (2010)).
On the other hand, as for experimental animals, in all of tests in which Printex 90 (primary particle size: 14 nm, specific surface area: 227 plus or minus 18.8 m2/g, Mass Median Aerodynamic Diameter (MMAD): 0.64 micrometer) was given by inhalation exposure to female mice for 13.5 months, to female rats for 43 weeks or 86 weeks, or to female rats for 24 months, increased incidences of pulmonary benign/malignant tumors such as alveolar/bronchiolar adenoma, adenocarcinoma, squamous cell carcinoma were observed (IARC 93 (2010), SIDS (2007)). In addition, in a 2-year test in which Elftex 12 (67% of the total particles are large particles (particle size: 2.0-2.4 micrometer; MMAD: 2.0 micrometer) and 33% are small particles (particle size: 0.02-0.1 micrometer)) was given by inhalation exposure to female and male rats, no increased incidence of lung tumors was shown in males, but a dose-dependent increase in the incidence of lung adenomas and adenocarcinomas was observed in females (IARC 93 (2010), SIDS (2007)). Other than these, even in tests where these two kinds of products of this substance were administered intratracheally to female rats, an increase in lung tumors was confirmed (IARC 93 (2010), SIDS (2007)).
Based on the human epidemiological findings and animal test results above, IARC classified it in Group 2B (IARC 93 (2010)) and ACGIH in A3 (ACGIH (7th, 2011)). Therefore, it was classified in Category 2 for this hazard class.
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs)


Danger
H372 P260
P264
P270
P314
P501
As for humans, it was presumed that by repeated inhalation exposure to this substance in manufacturing plants of this substance, a decrease in pulmonary function, an increase in the incidence of respiratory symptoms, and abnormal findings in chest radiographs would be observed, but in the results of large-scale epidemiological studies covering 19 plants in 7 European countries, a slight decrease in pulmonary function parameters was only suggested as a predicted value after a 40-year exposure at a concentration of 1.0 mg/m3 (respirable dust, 8-hour TWA) (SIDS (2007), ACGIH (7th, 2011)). It was estimated that the FEV1 (forced expiratory volume in 1 second) value would decrease on average by 49, 91, and 169 mL, respectively after a 40-year inhalation exposure at 1, 2, and 3.5 mg/m3 (8-hour TWA value), however, it was considered as a very slight change when compared with the fact that in adult men, FEV1 decreased by 1,200 mL on average over 40 years due to aging (SIDS (2007)). Also, in research results for North American manufacturing factories, a similar depression of respiratory function of reduced FEV1 by 28 mL was shown by the exposure at 1 mg/m3 for 40 years (SIDS (2007)), however, it is considered that as for both results in Europe and North America, the decrease in the FEV1 value as an index was a decrease within the range of 95% confidence interval of the normal value of the FEV1 value (ACGIH (7th, 2011)).
As for experimental animals, in a test in which male rats were exposed by inhalation to this substance for 13 weeks (6 hours/day, 5 days/week), at or above 7.1 mg/m3 (converted guidance value: 0.0051 mg/L/6 hr), inflammation, hyperplasia, and fibrosis of the alveolar epithelium were observed, a decrease in the dust clearance rate by the lung was also observed, and the NOAEL was 1.0 mg/m3 (SIDS (2007)). In addition, in a test with female and male rats exposed by inhalation for 2 years (16 hours/day, 5 days/week), at or above 2.5 mg/m3 (converted guidance value: 0.0046 mg/L/6 hr), inflammation, squamous metaplasia, hyperplasia, and chronic-active inflammation of the alveolar epithelium were similarly seen in the lung (SIDS (2007)). Besides, there is a report that as a result of inhalation exposure in female rats, mice, and hamsters for 13 weeks at the same concentration, inflammatory tissue changes in the lungs were clearly seen in rats at or above 7 mg/m3, and these findings were stronger than in mice and hamsters, on the other hand, the clearance rate from the lung was the fastest in hamsters (ACGIH (7th, 2011)), and it was suggested that there was a species difference in the adverse effects on the respiratory system and clearance from the lung. Other than these, no adverse effects were observed in a 41-week dermal administration test with mice or 2-year feeding administration tests with rats or mice (SIDS (2007)).
From the above, in the inhalation route, only a slight decrease in respiratory function was suggested for this substance in humans, but as for experimental animals, since a significant tissue change in the lung was shown within the dose range for Category 1, it was classified in Category 1 (respiratory organs).
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) Not classified
-
-
- - From 72-hour EC50 > 10000 mg/L for algae (Desmodesmus subspicatus), 24-hour EC50 > 5600 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 1000 mg/L for fish (Leuciscus idus) (all SIDS, 2007), it is estimated that the substance does not show such toxicity at its water solubility (insoluble (HSDB, 2009)), therefore, it was classified as "Not classified."
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - Acute toxicity was not reported at levels up to the water solubility due to being insoluble in water, and behavior in water and bioaccumulation are unknown. Therefore, the classification is not possible.
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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