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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	8001-54-5
Chemical Name	Benzalkonium chloride
Substance ID	H29-B-091
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	FY2011
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	- -	-	-	There is the information that it is poorly flammable (GESTIS (Access on September 2017)), but the classification is not possible due to no data
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	- -	-	-	It is an organic substance which does not contain oxygen or fluorine but contains chlorine, and the chlorine is ionically bonded to the element other than carbon or hydrogen (N) and does not contribute to oxidation.
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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on reports of LD50 values of 240 mg/kg (IPCS, PIM G022 (1998)) and 304.5 mg/kg (82.26% formulation, a converted value equivalent to 100%: 250 mg/kg) (EPA Pesticide (2006)) for rats, it was classified in Category 3.
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	There are reports of LD50 values for rats of 930 mg/kg (82.26% formulation, a converted value equivalent to 100%: 765 mg/kg) (EPA Pesticide (2006)) and 1,560 mg/kg (IPCS, PIM G022 (1998)). One value corresponds to Category 3, and the other corresponds to Category 4. The category with the higher hazard was adopted, and it was classified in Category 3.
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)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on a report that an LC50 value was 0.053 mg/L in a 4-hour inhalation exposure test with rats on the aerosol of this substance (HSDB (Access on August 2017)), it was classified in Category 2.
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	Based on reports that this substance is corrosive or severely irritating to the skin (NICNAS IMAP (Access on September 2017), IPCS, PIM G022 (1998), EPA Pesticide (2006)), and that it was corrosive in a skin irritation test (OPPTS 870.2500) with rabbits (EPA Pesticide (2006)), it was classified in Category 1.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It was classified in Category 1 for skin corrosion/irritation. In addition, there is a report that in an eye irritation test (OECD TG 405 compliant) with rabbits, as a result of application of 0.1 mL of a 10% solution of this substance into the conjunctival sacs of three rabbits, severe damage to the cornea, iris, and conjunctiva occurred in all the animals, and damage of the cornea (corneal opacity, corneal damage) and iris (iritis) persisted until day 21 of the end of the observation period; as for redness and edema of the conjunctiva, damage persisted until day 21 in 2 out of the three animals, and MMAS (irritation score: corresponding to AOI) was 108 (maximum value 110) (ECETOC TR48 (2) (1998)). Therefore, it was classified in Category 1.
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	There is a description that occupational asthma occurred due to prolonged exposure to this substance (IPCS, PIM G022 (1998)). Therefore, it was classified in Category 1. By reviewing the contents of the information source, the category was changed from the previous classification.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	There is a report that two physicians were sensitized by handling instruments immersed in disinfectant containing this substance and they developed allergic conjunctivitis from ophthalmic solutions containing this substance (IPCS, PIM G022 (1998), NICNAS IMAP (Access on September 2017)). There is a report that all 6 patients who had a history of using the emollient containing 6% of this substance and developed flexural eczema were shown to have a Type 4 allergy to this substance in a patch test (HSDB (Access on August 2017)). In addition, this substance is listed as a sensitizer in Contact Dermatitis (Frosch) (5th, 2011). Therefore, it was classified in Category 1.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There are no in vivo data. As for in vitro, a bacterial reverse mutation test was negative, and a micronucleus test with human peripheral blood was positive (HSDB (Access on August 2017)). Besides, a negative result in an in-vivo mutagenicity test in the previous classification could not be confirmed.
6	Carcinogenicity	Classification not possible	- -	-	-	EPA concluded that this substance does not show carcinogenicity in rats and mice (EPA Pesticide (2006)). In addition, there is a report that as a result of dermal application (0.2 mL) of the 8.5% or 17% solution of this substance to mice for 80 weeks and to rabbits for 90 weeks, ulcer and inflammation occurred on the application site in both of animal species, but no development of tumors was observed (HSDB (Access on August 2017)). There are no classification results by other organizations. From the above, both of the test results in the oral and dermal routes in experimental animals were negative. However, this substance is an irritating substance, but there is no information on carcinogenicity in the inhalation route, therefore, it was classified as "Classification not possible," but "Not classified."
7	Reproductive toxicity	Classification not possible	- -	-	-	Female rats were given a single vaginal administration of 25-200 mg/kg of this substance and slaughtered on day 21 of pregnancy. As a result, in maternal animals, reduced body weight gain and vaginitis at or above 100 mg/kg/day, a decrease in the number of implantations at 200 mg/kg/day were observed, and in fetuses, a dose dependent decrease in the numbers of live pups at or above 50 mg/kg/day and an incidence of sternal defects (absent, nonaligned) at or above 100 mg/kg/day were observed (HSDB (Access on August 2017)). However, it is considered that this data is special in its administration route and is not appropriate to be used for classification. Because there are no available data other than these, it was classified as "Classification not possible" due to lack of data. Besides, EMEA (1997), which was adopted as the evidence for Category 2 in the previous classification, could not be obtained, and the classification result was changed.
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	As for humans, there is a report that two and a half-month-old twins after birth who took an 11% solution of this substance by accidental ingestion developed fever, dehydration, cough, salivation, and numerous oral and pharyngeal lesions within 24 hours; and one of them developed chemical pneumonitis, but both recovered due to treatment (IPCS, PIM G022 (1998)). As for experimental animals, there is a report that in a 6-hour single inhalation exposure test with rats exposed to 0.03 mg/L of the aerosol of this substance, in addition to an increase in the lung weight, strong inflammatory and irritant reactions such as increases in total proteins, the hyaluronic acid content, LDH activity, and the amount of IL-6 and IgE in the bronchoalveolar lavage fluid were observed (HSDB (Access on August 2017)). The converted 4-hour equivalent value of the dose of this test is 0.045 mg/L, which corresponds to Category 1 in the GHS classification guidance for the Japanese government. Since the human case corresponds to an aspiration hazard, it was not adopted as the evidence for the classification for this hazard class. Although the dose of effects on the lung in animals is equivalent to Category 1 if judged from the guidance value, because it is data from the information source in List 2, and it does not meet the Decision criteria 1b 3) (OECD TG test and GLP compliant test), it was classified in Category 2 (respiratory organs) according to the GHS classification guidance for the Japanese government. It was classified in Category 2 (lung) in the previous classification based on the same test results with rats, but the classification result was changed because the classification as respiratory organs is considered appropriate.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	As for humans, there is no relevant report, but occupational asthma is reported after prolonged exposure (IPCS, PIM G022 (1998)). As for experimental animals, in a 12-week toxicity test with rats dosed by gavage, deaths (2 animals) and decreased body weight gain were reported at 100 mg/kg/day which is the upper limit of the guidance value for Category 2, but no adverse effect was reported on other test indexes including pathological examinations (HSDB (Access on August 2017)). In a 52-week toxicity test with dogs dosed by gavage, moderate to severe irritation and subacute inflammation of the small intestine at or above 12.5 mg/kg/day, and death and congestion of the stomach and small intestine at or above 25 mg/kg/day were reported (HSDB (Access on August 2017)). Among the above, the deaths in the rat test were not adopted as evidence of the classification because no adverse effects were reported in other test indexes including pathological examinations. Also, since the effect on the digestive system in the dog test is considered to be due to irritation, it was not adopted as evidence of the classification. Therefore, it was classified as "Classification not possible."
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	As for humans, there is a report that two and a half-month-old twins after birth who took an 11% solution of this substance by accidental ingestion developed fever, dehydration, cough, salivation, and numerous oral and pharyngeal lesions within 24 hours; and one of them developed chemical pneumonitis (IPCS, PIM G022 (1998)). From this case, it was classified in Category 1.

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	From 24-hour EC50 = 0.036 mg/L [converted value 0.018 mg/L (purity 50%)] for crustacea (Daphnia magna) (NLM HSDB: 2010, EPA AQUIRE: 2017, Canton, J. H. et al. (1983)), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	Chronic toxicity data were not obtained. Due to being not rapidly degradable (BioWin), and acute toxicity Category 1, it was classified in Category 1.
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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