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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1317-36-8
Chemical Name	Lead(II) oxide [Litharge]
Substance ID	H29-B-108
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) (2002)).
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 not combustible (ICSC (J) (2002)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (J) (2002)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains metals (Pb), but it is estimated that it does not react vigorously with water from the measurement result of water solubility of 0.017 g/L (20 deg C) (HSDB (Access on August 2017)).
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)	Not classified	- -	-	-	Based on a reported LD50 value of > 2,000 mg/kg (HSDB (Access on August 2017)) for rats, it was classified as "Not classified." The classification result was changed from the previous one by using new information sources.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a reported LD50 value of > 2,000 mg/kg (HSDB (Access on August 2017)) for rabbits, it was classified as "Not classified." The classification result was changed from the previous one by using new information sources.
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)	Not classified	- -	-	-	Based on a reported LC50 value of > 5.05 mg/L (HSDB (Access on August 2017)) in a 4-hour inhalation exposure test with rats, it was classified as "Not classified." The classification result was changed from the previous one by using new information sources.
2	Skin corrosion/irritation	Not classified	- -	-	-	It is described that in a skin irritation test (OECD TG 404 compliant) with rabbits, the irritation score was 0 in all three animals, and no irritation was observed as the result of semi-occlusive application of 0.5 g of this substance (HSDB (Access on August 2017)), therefore, it was classified as "Not classified." The category was revised based on the information obtained in this investigation.
3	Serious eye damage/eye irritation	Not classified	- -	-	-	Based on a report that in an eye irritation test (OECD TG 405 compliant) with rabbits, as a result of application of 0.1g of this substance for 72 hours, slight redness in one animal was produced 1 hour after instillation, but after 24 and 72 hours, neither of the three test animals showed irritation, and it was not irritating (HSDB (Access on August 2017)). Therefore, it was classified as "Not classified." The category was revised based on information obtained by this investigation.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	There is a report that in a skin sensitization test (OECD TG 406 compliant) with guinea pigs, there was no skin reaction 24 hours and 48 hours after a challenge to 10 of a sensitized group, the positive reaction rate was 0%, and this substance is not a sensitizer (HSDB (Access on August 2017)). However, because other information on animals or humans could not be obtained, it was classified as "Classification not possible."
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	Though there is no information on this substance, it was classified based on the information on inorganic lead compounds. As for in vivo, chromosomal aberration tests with rat or mouse bone marrow cells and a micronucleus test with rat bone marrow cells were positive, and there were positive results in sister chromatid exchange tests with mouse bone marrow cells, but negative results were also found (IARC 87 (2006), ATSDR (2007), NICNAS (2007)). As for in vitro, there were positive results in bacterial reverse mutation tests, and gene mutation tests and micronucleus tests with mammalian cultured cells, but negative results were also seen in bacterial reverse mutation tests, and gene mutation tests, micronucleus tests, and sister chromatid exchange tests with mammalian cultured cells (IARC 87 (2006), ATSDR (2007), NICNAS (2007)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government. Besides, in the previous classification, reports on human occupational exposure and descriptions on an epidemiology survey of lead compounds were adopted, however, they were not used in this classification since they provided inadequate information to use for the identification of a category.
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	There is no information on the carcinogenicity of this substance itself in humans, and the information in experimental animals is also limited. In a test in which male rats were exposed by inhalation to particles of this substance at an average concentration of 5.3 mg/m3 for 1 year, no tumors were found in the lung, and only kidney cancer was observed in 1/50 animals (IARC 87 (2006)). In addition, in a test in which 1 mg of this substance, 1 mg of mixture of this substance and benzo[a]pyrene, or 1 mg of benzo[a]pyrene were intratracheally administered to hamsters weekly for 10 weeks, and necropsy was done after 60 weeks, an increased incidence of adenoma and adenocarcinoma in the lung (mainly bronchioloalveolar area) was observed in the mixed administration of this substance and benzo[a]pyrene, and the hyperplasia and squamous metaplasia in the alveolar epithelium in the group treated with this substance alone, and only slight effects on the lung in the group treated with benzo[a]pyrene alone were observed. The authors concluded that this substance showed a co-carcinogenic effect with benzo[a]pyrene in the bronchiolo-alveolar area of hamster lungs (IARC 87 (2006)). It was judged that there was no information on carcinogenicity of this substance other than the above report. However, IARC classified inorganic lead compounds in Group 2A on the grounds of the following: from animal test data on lead acetate, lead subacetate, lead phosphate, and others, inorganic lead compounds induce mainly kidney cancer by oral administration; regarding carcinogenicity of inorganic lead compounds, there is limited evidence in humans, but there is sufficient evidence in experimental animals (IARC 87 (2006)). On the other hand, Japan Society for Occupational Health (JSOH) states as follows: the evidence data for IARC's classification in 2A was the result mainly based on kidney cancer by oral route; the test data of the respiratory tract route is only one item on the above, lead oxide (this substance), and no carcinogenicity was observed; epidemiology data in the respiratory tract route were also mainly on stomach cancer or lung cancer, but data on kidney cancer are few; in addition, there are also non-significant results, and it cannot be stated that sufficient verification of other carcinogenic factors has been done even for significant results; and evidence in epidemiological study is limited, and results in experimental animals are insufficient. Therefore, the classification results on lead and lead compounds in 1991 (Group 2B) was not changed, and lead and lead compounds (except for alkyl lead) were classified in Group 2B (OEL Documentations (2016)). Other than these, lead and inorganic lead compounds were classified in B2 by EPA (IRIS (1988)) and in A3 by ACGIH (ACGIH (7th, 2001)). From the above, the latest classification result for lead compounds by JSOH, which had been reevaluated by taking account into IARC's classification, was also applied to this substance, therefore, it was classified in Category 2 for this hazard class.
7	Reproductive toxicity	Category 1A	Danger	H360	P308+P313 P201 P202 P280 P405 P501	There are many pieces of evidence proving that lead and lead compounds show reproductive and developmental toxicity. In the OEL Documentations, Japan Society for Occupational Health (JSOH) discussed the relevant reports, citing the review by NTP (2012), as follows: as effects on men by exposure to lead, there are plural reports that increases in the incidence of asthenospermia, decreased sperm, and malformed sperm were observed in a group of workers with high blood lead level who were engaged in a battery factory or lead smelter, and there are reports such that the birth rate was low in the lead exposure group of men working in a heavy metal factory, especially in the group with more than 5 years of exposure, a decrease in the birth rate was observed, and it was suggested that a prolonged exposure to lead causes a decrease in a fertility rate (OEL Documentations (2013)). As for effects on women, there are reports including the following: in the women who worked in a lead factory and were exposed, abnormal ovulation occurred at a high rate compared to the control group, and a relevance between urinary ALA (5-aminolevulinate) concentration and amenorrhea cycle was observed; with the increasing blood lead level of women exposed to lead, the risks of low birth weight and growth retardation in the uterus were significantly increased in Taiwan; a significantly low mental development index in the growing process of newborns was observed in the group of the high lead concentration in the umbilical cord blood but had nothing to do with the blood concentration in postnatal children; furthermore, there is sufficient evidence in epidemiological study results on lead concentration in mother's blood, growth delay of the fetuses, and the decreased neonatal weight (OEL Documentations (2013)). Based on the above epidemiological study results, JSOH classified lead and lead compounds in reproductive toxicants Group 1 (OEL Documentations (2013)). Therefore, it was classified in Category 1A for this hazard class.
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance is an inorganic lead compound. There is no information on single exposure of this substance. However, the toxicity information of lead would be considered to be a reference. For humans, as symptoms of acute toxicity of lead, apathy, restlessness, irritability, inattentiveness, headaches, muscular tremor, hallucinations, loss of memory, and kidney damage are reported (OEL Documentations (Japan Society For Occupational Health (JSOH), 2013), ATSDR (2007), EHC 3 (1977)). Therefore, it was classified in Category 1 (central nervous system, kidney).
9	Specific target organ toxicity - Repeated exposure	Category 1 (haemal system, nervous system, cardiovascular system, kidney)	Danger	H372	P260 P264 P270 P314 P501	As for humans, there is no information on this substance, but it is considered that it can be classified based on effects of inorganic lead compounds. The most sensitive target of lead toxicity is the developing nervous system, haemal system, cardiovascular system and kidney. However, due to the multi-modes of action of lead in biological systems, lead could potentially affect any system or organ in the body (ATSDR (2007)). As for the effects on the nervous system, symptoms develop following prolonged exposure and include dullness, irritability, poor attention span, epigastric pain, constipation, vomiting, convulsions, coma, and death. Lead poisoning in children can leave residual cognitive deficits that can be still detected in adulthood. As for effects on the haemal system, lead is known to change the haemal system by inhibiting the activity of some enzymes participating in biosynthesis of heme. As for effects on the cardiovascular system, studies on lead workers suggest that long-term exposure to lead may be associated with increased mortality due to cerebrovascular disease. The same is found in a study of adults from the general population who were hospitalized for lead poisoning during childhood. As for effects on the kidney, there is a description that lead also affects kidney function, and changes a glomerular filtration rate (ATSDR (2007)). As for experimental animals, there is a report that in a 5-month feeding study with mice, at 10 mg/kg/day within a guidance value range for Category 1, anaemia (decreases in hemoglobin concentration, hematocrit value, erythrocyte count, and leucocyte count, an increase in the incidence of irregular shaped erythrocytes) were observed (NICNAS (2007)). From the above, this substance was classified in Category 1 (haemal system, nervous system, cardiovascular system, kidney). Since new information sources were used, the classification result was different from the previous classification.
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)	Classification not possible	- -	-	-	Reliable acute toxicity data were not obtained.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
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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