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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	63-25-2
Chemical Name	1-Naphthyl N-methylcarbamate (Carbaryl)
Substance ID	H30-B-002-MHLW, MOE
Classification year (FY)	FY2018
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	Classification not possible	- -	-	-	No data available. Besides, it is described that this substance does not burn or burns with difficulty (HSDB (Accessed Jun. 2018)).
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	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 oxygen (but not fluorine or chlorine) which is 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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] As for this substance, based on expert judgment, LD50 values of EPA Pesticide and EFSA in (1) and (2), in which individual test data, not the range, are described, were preferentially adopted, and it was classified in Category 4. [Evidence Data] (1) LD50 values for rats: 302.6 mg/kg (male), 311.5 mg/kg (female) (EPA Pesticide (2004)) (2) LD50 value for rats: 614 mg/kg (EFSA (2006)) [Reference Data, etc.] (3) LD50 values for rats: 220-720 mg/kg (JMPR 167 (2001)) (4) LD50 values for rats: 200-850 mg/kg (Canada (2009)) (5) Twenty-two LD50 values (EHC 153 (1994), IARC 12 (1976), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 1989), ACGIH (7th, 2008)) were reported.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] According to (1)-(3), it was classified as "Not classified" (Category 5 in UN GHS classification or corresponds to "Not classified"). The category was changed from the previous classification by use of the new information sources. [Evidence Data] (1) LD50 value for rats: > 4,000 mg/kg (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 1989), ACGIH (7th, 2008), EHC 153 (1994), Canada (2009)) (2) LD50 value for rats: > 2,000 mg/kg (JMPR 167 (2001)) (3) LD50 value for rabbits: > 2,000 mg/kg (EPA Pesticide (2004), EHC 153 (1994), Canada (2009))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, since the vapor pressure of this substance is very low (< 0.005 Pa (25 deg C) (Merck)), it is considered that the data described in the previous classification came from a test using the mist.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] From (1) and (2), it was classified in Category 4. [Evidence Data] (1) LC50 value for rats: 2.43 mg/L (female) (4 hours) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), EFSA (2006)) (2) LC50 value for rats: > 3.4 mg/L (4 hours, 2/5 animals died at 3.4 mg/L) (EPA Pesticide (2004), Canada (2009)) [Reference Data, etc.] (3) LC50 value for rats: > 4.26 mg/L (male) (Exposure time is unknown) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)) (4) There is a report that 1/5 females died in a 4-hour exposure of rats to 0.792 mg/L of the aerosol of this substance (EHC 153 (1994)).
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] According to (1), (2), it was classified as "Not classified." Besides, there is also a report (3) that transient erythema was observed, but exposure time and observation period are unknown, therefore, it was not used for judgment in classification. Since the classification categories were decided to comply with the classification JIS (JIS Z7252), Category 3 in the previous classification was changed to "Not classified." [Evidence Data] (1) There is a report that in human exposure, it did not show skin irritation in controlled trials (ACGIH (2007)). (2) There is a report that in a skin irritation test with rabbits, it was not irritating (EPA Pesticide (2004)). [Reference Data, etc.] (3) There is a report that transient erythema was observed in a skin irritation test with rabbits (EHC (1994)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] From (1) and (2), it was judged to cause reversible and weak irritation. Therefore, it was classified in Category 2B. [Evidence Data] (1) There is a report that in humans, mild swelling of the eyelids and mild corneal irritation were seen, but recovery was rapid (PIM 147 (1997)). (2) There are reports that in eye irritation tests (four tests on different concentrations of solutions) with rabbits, no injury (25% solution) and mild injury in 1/5 animals (10% solution) were observed, and irritation in the conjunctiva occurred but resolved after two days (undiluted solution), and conjunctival irritation in 6/6 animals and transient iritis in 2/6 animals occurred but resolved after three days (43.4% solution) (EHC 153 (1994)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] While animal test data (2)-(4) suggesting that this substance is not sensitizing to the skin are obtained, there are also human data (1) suggesting skin sensitization, and no sufficient evidence was obtained to determine whether or not it is sensitizing. Therefore, it was classified as "Classification not possible." [Reference Data, etc.] (1) There is a report that skin eruption was observed after accidental exposure to humans (IPCS PIM 147 (Accessed Jul. 2018)). (2) There is a report that in a skin sensitization test with guinea pigs, when this substance (0.25% methyl cellulose solution) was applied, no skin sensitization was observed (EHC 153 (1994)). (3) There are reports that no skin sensitization was observed in plural animal studies (IPCS PIM 147 (Accessed Jul. 2018)). (4) There is a report that this substance is not skin sensitizing (EPA Pesticide (2004)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] According to (1) and (2), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for in vivo, it was negative in a mouse dominant lethal test, a mouse bone marrow micronucleus test, and chromosomal aberration tests with bone marrow cells of rats and hamsters (EHC 153 (1994), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) As for in vitro, there are reports that bacterial reverse mutation tests were negative (some positive), that DNA repair tests with Bacillus subtilis were negative, that a gene mutation test with cultured mammalian cells was negative, and that a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells were positive (Health Canada (2009), EFSA (2006), EHC 153 (1994), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] As for carcinogenicity, there is no available report on humans. From (1)-(3), although classifications by other organizations were performed, it was classified in Category 1B based on malignant tumors observed in multiple organs in 2 species of animals. [Evidence Data] (1) In a carcinogenicity study in which 100-8,000 ppm of this substance was administered by feeding to mice for 2 years, significant increases in hemangiosarcomas of the liver and spleen in males at or above 1,000 ppm, renal tubular tumors of the kidney in males at 8,000 ppm and hepatocellular tumors of the liver in females at 8,000 ppm were observed (JMPR (2001), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) In a carcinogenicity study in which 250-7,500 ppm of this substance was administered by feeding to rats for 2 years, significant increases in transitional cell papillomas and carcinomas of the urinary bladder in both sexes, and follicular cell adenoma of the thyroid in males were observed at 7,500 ppm (JMPR (2001), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) As for classifications by other organizations, it was classified in Group 3 by IARC (IARC Suppl. 7 (1987)), in A4 by ACGIH (ACGIH (7th, 2008)), in Carc. 2 by EU CLP, and as L (Likely to be carcinogenic to humans) by EPA OPP RED (Office of Pesticide Program, Reregistration Eligibility Decision (2008)), respectively.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] According to (1), in a two-generation reproductive toxicity test with rats, a decrease in the survival rate of pups was observed but no statistically significant difference was found. Also, in the result of a developmental toxicity test of (2), teratogenicity was not found. JMPR concluded that no effects on fertility of parental animals or on pups were observed in any generation and this substance has no adverse effects on fertility (JMPR (2001)), but there is no clear evidence to give a category from known findings. Therefore, it was classified as "Classification not possible." [Evidence Data] (1) In a two-generation reproductive toxicity test with rats by the oral route (feeding), as for parental animals, decreased body weight gain, etc. were observed at or above 300 ppm in males and at 1,500 ppm in females (JMPR (2001)). Although a decrease in survival rate was observed at or above 300 ppm in F1 pups, there was no statistically significant difference (JMPR (2001), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) In a developmental toxicity test with rats administered by gavage on gestational day 6-20, decreased body weight gain and salivation at 30 mg/kg/day in maternal animals, low body weight and non-ossification at 30 mg/kg/day in fetuses were observed, but no teratogenicity was observed (JMPR (2001)).
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on human findings of (1)-(2), it was classified in Category 1 (nervous system). [Evidence Data] (1) It is described that this substance inhibits cholinesterase activity in humans, overstimulates the nervous system, resulting in nausea, dizziness and confusion, and high dose exposure causes respiratory paralysis, leading to death (EPA Pesticide (2004)). (2) There is a report that in a case of oral ingestion of 250 mg/kg of this substance in humans, epigastric pain and profuse sweating occurred after 20 minutes, in addition, there is a report that in a case of oral ingestion of 420 mg/kg of this substance, vision troubles, weakness, profuse sweating and headache occurred after 85 minutes (EHC 153 (1994)). (3) There is a report that in an acute neurotoxicity test in which rats were orally administered at a single dose of 10-125 mg/kg, symptoms such as tremor, ataxia, deterioration of gait, decreased motor activity, and decreased arousal level were observed at 125 mg/kg within the range of Category 1 (JMPR (2001)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] From (1) and (2), it was classified in Category 1 (nervous system). Besides, as for the kidneys, there is a human case but only one case, and as for the liver and kidneys, a report in Food Safety Commission of Japan in (5) is prioritized, and there is a report that no effect was observed at doses below the range of Category 2 in experimental animals. Therefore, these were excluded from the target organs. [Evidence Data] (1) There is a report that a 75-year-old man exposed by inhalation to a 10% formulation of this substance for 8 months developed symptoms related to cholinesterase inhibitory action (EHC 153 (1994)), and it is described in HSDB that these symptoms were headache, memory disorders, muscle weakness, muscle fasciculation, anorexia and weight loss, and the main symptoms improved on termination of exposure (HSDB (Accessed Jul. 2018)). (2) There is a description that there are five case reports where this substance is regarded to be a cause of chronic nervous system or mental disorder (EPA Pesticide (2004) (IRED)). [Reference Data, etc.] (3) There is a report that as a result of having human volunteers ingest this substance at 0.06 or 0.13 mg/kg/day for 6 weeks, an increase in the ratio of amino acid nitrogen to creatinine in the urine was observed in the high dose group, and a possibility of inhibition of reabsorption of amino acids in the proximal convoluted tubules was suggested (EHC 153 (1994), OEL Documentations (Japan Society For Occupational Health (JSOH), 1989), IPCS PIM147 (Accessed Jul. 2018)). (4) In a 2-year feeding study with rats, at 400 ppm (15.6 mg/kg/day, within the range of Category 2), diffuse cloudy swelling of the renal tubules (at the time of interim sacrifices after one year and at the end of 2-year administration) and an increase in the frequency of cloudy swelling of the hepatic cords (at the end of 2-year administration) were observed (IRIS (1987)). (5) There is a report that in a study with rats administered by feeding at 50-7,500 ppm for 2 years, at or above 7,500 ppm (converted guidance value: 350 (male), 485 (female) mg/kg/day) exceeding the range of Category 2, hepatocellular hypertrophy, epithelial hyperplasia of the renal pelvis, transitional cell hyperplasia and transitional cell papilloma of the urinary bladder, and follicular cell hypertrophy and follicular cell adenomas (male only) of the thyroid were observed, but there was no significant difference at 1,500 ppm (converted guidance value: 60.2 (male), 78.6 (female) mg/kg/day) within the range of Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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	It was classified in Category 1 from 48-hour EC50 = 0.00026 mg/L for crustacea (Daphnia magna) (WHO/IPCS EHC: 1994).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to rapid degradability (readily biodegradable, a degradation rate by BOD: 71% (J-CHECK, 1983)), and 21-day NOEC (reproduction inhibition) = 0.0002 mg/L for crustacea (Daphnia magna) (EPA AQUIRE: 2018, Toumi, H. et al. (2016)).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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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