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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	75-12-7
Chemical Name	Formamide
Substance ID	H26-B-097, R-043
Classification year (FY)	FY2014
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)
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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" based on a flash point of 120 deg C (closed cup) (ICSC (2013)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 500 deg C (ICSC (2013)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data available. Besides, it is described that it attacks copper and so on (HSDB (Access on September 2014)).

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 reports of LD50 values of 3,200 mg/kg, 5,325 mg/kg (SIDS (2013)) and about 6,000 mg/kg (ACGIH (7th, 2001)) for rats, it was classified as "Not classified."
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on reports of an LD50 value of 3,000 mg/kg for rats (SIDS (2013)) and LD50 values of 6,000 mg/kg and >17,000 mg/kg for rabbits (ACGIH (7th, 2001)), it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on reports of an LC50 value (4 hours) of >21 mg/L for rats (SIDS (2013)) and an LC50 value (6 hours) of 3,900 ppm (converted 4-hour equivalent value: 10.8 mg/L) for rats (ACGIH (7th, 2001)), it was classified as "Not classified." Besides, since all LC50 values were higher than the saturated vapour concentration (2.36 mg/L), the reference value of the mist was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that in an irritation test with guinea pigs, there was a slight and reversible irritation (ACGIH (7th, 2001)). In addition, based on a result that in a skin irritation test in which the undiluted liquid of this substance was applied to rabbits for 20 hours, slight to moderate erythema was observed and desquamation was observed 8 days after application, it was judged to be slightly irritating (SIDS (2013)). From the above results, it was classified as "Not classified" (Category 3 in UN GHS classification). By adding information in SIDS (2013), according to the revised GHS classification guidance for the Japanese government, the category was changed.
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Since there are 3 reports that in any eye irritation test with rabbits, mild irritation was observed (SIDS (2013), ACGIH (7th, 2001)), it was classified in Category 2B.
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. Besides, although there are 3 reports that no sensitization was observed in any skin sensitization test with guinea pigs (SIDS (2013), ACGIH (7th, 2001)), details such as the test method were unknown, therefore, it was judged as insufficient data for classification.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, it was negative in a dominant lethal test with mice, positive in a mouse bone marrow micronucleus test by intraperitoneal administration, and negative in a micronucleus test with peripheral blood erythrocytes by 90-day administration by gavage and a chromosomal aberration test with rat bone marrow cells by subcutaneous administration (SIDS (2013), NTP DB (Access on October 2014)). As for in vitro, it was negative in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (SIDS (2013), NTP DB (Access on October 2014), ACGIH (7th, 2001)). Although a positive finding in the micronucleus test with mouse bone marrow cells was observed by intraperitoneal administration at high doses (SIDS (2013)), and there were negative results in an in vitro chromosomal aberration test and a micronucleus test with peripheral blood by oral administration, therefore, the positive result was not judged as the appropriate evidence of micronucleus induction from the viewpoint of weight of evidence. And micronucleus induction was ambiguous because of reciprocity between the data, therefore, it was classified as "Classification not possible."
6	Carcinogenicity	Classification not possible	- -	-	-	There was no classification for carcinogenicity by international evaluation organizations. In NTP (2008), it was described that in 2-year carcinogenicity tests with male and female F344 rats and B6C3F1 mice dosed by gavage, no carcinogenicity was observed in rats, but it was described that there was clear evidence of carcinogenicity in male mice based on an increased incidence of hemangiosarcoma in the liver, and there was equivocal evidence of carcinogenicity in female mice based on an increased combined incidence of hepatocellular adenomas and carcinomas (NTP TR541 (2008), NTP DB (Access on October 2014), SIDS (2013)). There were no findings on humans. From the above, although there were data in experimental animals, classification was not possible due to lack of data on the carcinogenicity of this substance to humans.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	There is a report that in a continuous breeding study with mice by the oral route (drinking water), fertility effects (reduced fertility rate, reduced litter size) were observed at a dose (750 ppm (144-226 mg/kg/day)) where parental toxicity (decreased body weight gain) was observed (NTP DB (Access on 2014), SIDS (2013)). There is a report that in a teratogenicity test with mice by the oral route (gavage), skeletal malformations (exencephaly, presphenoidal aplasia, brachygnathia inferior, cleft palate, fused ribs, clefts and hypoplasia of vertebral bodies) were observed in fetuses at a dose (198 mg/kg/day) where no maternal toxicity was observed (SIDS (2013)). From the above, since malformations were observed in fetuses at a dose where no parental toxicity was observed, it was classified in Category 1B.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	There were no human data. As for experimental animals, by an inhalation exposure to the mist with rats, no toxic symptoms were observed at a high concentration of 3,900 ppm (7.2 mg/L) exceeding the guidance value range for Category 2. It is reported that irregular respiration, apathy and atony were observed at 227-7,251 mg/kg in rats by the oral administration (SIDS (2013), ACGIH (7th, 2001)). There were no other data. From the above, since there were no target organs indicating clear toxic effects, it was classified as "Classification not possible."
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There was no hazardous information on humans. As for experimental animals, in tests with rats dosed by gavage for 4 weeks or 14 weeks, and with mice for 14 weeks, at doses (80-113 mg/kg/day (converted guidance value: 25.1-62.3 mg/kg/day)) corresponding to Category 2, effects on the hemal system (rat: increases in erythrocyte counts and hematocrit values (both test period), an increase in hemoglobin concentrations (14 weeks only), reduced thrombocytes and extended coagulation (4 weeks only); mouse: decreases in erythrocyte counts and hematocrit values, increases in MCV and MCHC value) were observed in both rats and mice, and effects on the pancreas (hyperplasia and chronic inflammation in the pancreatic duct epithelium) were observed in mice (SIDS (2013), NTP TR 541 (2008)). On the other hand, by the inhalation route, in a test in which rats were exposed to this substance (estimated as mist) for 2 weeks by inhalation, a decrease in platelet count was observed at or above 500 ppm (0.93 mg/L (converted guidance value: 0.10 mg/L/6 hours)) (SIDS (2013), ACGIH (7th, 2001)). Additionally, in a 90-day dermal administration test with rats, increases in erythrocyte counts and hemoglobin concentrations were observed at a high dose (300 mg/kg/day) corresponding to "Not classified" (SIDS (2013), ACGIH (7th, 2001)). Thus, effects on the hemal system lacked coherence, and it was described that in the reports of 14-week gavage tests with rats and mice, in some or all of hematological test variable items, it was considered that clinical significance may be equivocal or absent (NTP TR 541 (2008)). Therefore, it was judged inappropriate to adopt the hemal system as a target organ. Moreover, since no tissue changes in the pancreas including the pancreas duct were observed in all tests (SIDS (2013), NTP TR 541 (2008), ACGIH (7th, 2001)), the pancreas was excluded from the target organs. Additionally, although effects on the testis and kidney were shown in rats or mice by some route, all of these were findings at high doses corresponding to "Not classified" (SIDS (2013), NTP TR 541 (2008)). From the above, in experimental animals, it was impossible to specify target organs clearly within the range of guidance value. And, there was no hazardous information on humans, therefore, classification was not possible due to lack of data.
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	- -	-	-	It was classified as "Not classified" from 72-hour ErC50 > 1000 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998)), 48-hour EC50 > 500 mg/L for crustacea (Daphnia magna) (SIDS, 2013), and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" then it is classified as "Not classified" due to rapid degradability (a 28-day degradation rate by DOC in a test according to OECD TG301A: 99% (SIDS, 2013)), and 72-hour NOEC > 10 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it corresponds to "Not classified" in acute toxicity for fish and is not water-insoluble (water solubility = 100,000 mg/L, PHYSPROP Database 2009). From the above results, it was classified as "Not classified."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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