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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1918-02-1
Chemical Name	Picloram
Substance ID	H26-B-008, -
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	- -	-	-	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. Besides, there is information that it is flammable (ICSC (2012)).
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	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available. Besides, it is described that it is slightly corrosive to mild steel only(HSDB (Access on Aug 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	- -	-	-	There are 5 reports of LD50 values of 4,012 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)), >5,000 mg/kg (male), 4,012 mg/kg (female) (EPA Pesticide (1995)), 8,200 mg/kg (ACGIH (7th, 2001)) and about 8,200 mg/kg (IARC 53 (1991)) for rats. It was classified as "Not classified" (2 values corresponded to Category 5 in UN GHS classification, and 3 values to "Not classified.") to which the larger number of values corresponded based on the revision of the GHS classification guidance for the Japanese Government.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on reports of LD50 values of >2,000 mg/kg (female and male) (EPA Pesticide (1995)) and >4,000 mg/kg (IARC 53 (1991)) for rabbits, it was classified as "Not classified." New information sources (EPA Pesticide (1995), IARC 53 (1991)) were added, and the classification was revised.
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. Besides, there is a report of an LC50 value (4 hours) of > 0.035 mg/L for rats (EPA Pesticide (1995)). Besides, since the LC50 value was higher than the saturated vapor concentration (7.8*10-13), the reference value as the dust was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that no skin irritation was observed in a test with rats, and it was classified in IV in the category of EPA Pesticide (EPA Pesticide (1995)). In addition, there is a report that in a skin irritation test with rabbits, slight erythema was observed in 5 of 6 animals after application of a formulation containing 20% of this substance but disappeared within 72 hours (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol.12 (1992)). On the other hand, although there are descriptions that it was irritating to the skin (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010), HSDB (Access on June 2014)), and that it was mildly irritating (HSDB (Access on June 2014)), the details were unknown. From the above results, it was classified as "Not classified" (Category 3 in UN GHS classification). Information was added, and classification was conducted according to the GHS Classification Guidance for the Japanese Government.
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is a report that it was moderately irritating to the eyes in a test with rats, and it was classified in III in the category of EPA Pesticide (EPA Pesticide (1995)). In addition, there is a report that there was moderate irritation which was reversible (HSDB (Access on June 2014)). From the above results, it was judged as Category 2. Since there was no detailed description of recovery properties, no subcategorization was done. Besides, there is a report that in a primary irritation test with rabbits, conjunctival edema, secretion and redness of the iris were observed after application of a 20% formulation of this substance but disappeared 14 days after treatment (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol.12 (1992)).
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	There are reports that no positive reaction was observed in a patch test with 29 healthy men under the modified Draize method (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol.12 (1992)), and that no sensitization was observed in a volunteer experiment with application to the skin at a 5% concentration (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). In addition, there is a report that there was no sensitization in a test with rats (EPA Pesticide (1995)). From the above results, it was judged as "Not classified."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a micronucleus test with mice, chromosomal aberration tests with rats and mice and an unscheduled DNA synthesis test (UDS test) with cultured rat primary hepatocytes (ACGIH (7th, 2001), EPA Pesticide (1995), IARC 53 (1991), Pesticide safety information (Japan Crop Protection Association, Access on June 2014)). As for in vitro, although it showed negative results all in multiple tests, including bacterial reverse mutation tests, gene mutation tests and chromosomal aberration tests with cultured mammalian cells (ACGIH (7th, 2001), IARC 53 (1991), EPA Pesticide (1995), NTP DB (Access on July 2014), Pesticide safety information (Japan Crop Protection Association, Access on June 2014)), there were also positive results in a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells (NTP DB (Access on July 2014)).
6	Carcinogenicity	Classification not possible	- -	-	-	Since it was classified in Group 3 by IARC (IARC 53 (1991)), in A4 by ACGIH (ACGIH (7th, 2001)) and as Group E by EPA (EPA Pesticide (1995)), the classification by IARC and ACGIH was prioritized, therefore, it was classified as "Classification not possible."
7	Reproductive toxicity	Not classified	- -	-	-	In a two-generation reproductive toxicity study with rats by the oral route, no reproductive toxicity was observed even at a dose (1,000 mg/kg/day) where parental toxicities (histopathological lesions in the kidney, occult blood in urine, decreased urine specific gravity, increased absolute and relative kidney weight, etc.) were observed (EPA Pesticide (1995)). There are reports that neither fetotoxicity nor teratogenicity was observed even at doses where maternal toxicity was observed in teratogenicity tests with rats and rabbits by the oral route (EPA Pesticide (1995)), and that in a teratogenicity test with rats by the oral route, although retarded fetal growth was observed at a dose (1,000 mg/kg/day) where maternal toxicity (details unknown) was observed, no effects on teratogenicity, postnatal survival rate and development were observed (ACGIH (7th, 2001), IARC 53 (1991)). Therefore, it was judged that there was no reproductive toxicity, and it was classified as "Not classified."
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	In humans, there are descriptions of irritation to the respiratory tract by the inhalation route, of nausea, burning sensation and cough by the oral route, and of nausea by the excessive ingestion (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010), HSDB (Access on June 2014)), and in experimental animals, although details such as the route were unknown, there are descriptions of hair loss, tachycardia, ataxia, diarrhea and leukopenia (HSDB (Access on June 2014)). From the above, this substance was considered to be irritating to the respiratory tract, and it was classified in Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	In 13-week feeding tests with mice and rats, no effects were observed in any tests within or lower than the dose range of Category 2 (ACGIH (7th, 2001), EPA Pesticide (1995), Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)). However, in a 2-year feeding test with rats, increased liver weight and centrilobular hepatocellular hypertrophy were observed at 60 mg/kg/day (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), IRIS (1992)), and in a 6-month feeding test with dogs, increased liver weight (male only) was observed at 35 mg/kg/day (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), IRIS (1992)). The US EPA considered 35 mg/kg/day where increased liver weight was observed in a 6-month feeding test with dogs as the lowest-observed-effect level (LOEL) and calculated the oral RfD value from a no-observed-effect level (NOEL) of 7 mg/kg/day (IRIS (1992)). Therefore, although no serious change was observed in the liver, it was classified in Category 2 (liver) in consideration of the opinion of EPA.
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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