GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 8001-54-5 |
| Chemical name | Benzalkonium chloride |
| Substance ID | 23A5054 |
| Fiscal year of classification conducted | FY2011 |
| Classifier(s) (Ministries) | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| New/Revised | New |
| Download in Excel format | Excel file |
| Item | Information |
|---|---|
| Guidance used for classification (External link) |
Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document （4th revised edition） |
| 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 |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
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 | - | - | - |
"Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - |
Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 7 | Flammable solids | Classification not possible | - | - | - |
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 | - | - | - |
"Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Classification not possible | - | - | - |
No data. |
| 11 | Self-heating substances and mixtures | Classification not possible | - | - | - |
No data. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - |
Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 14 | Oxidizing solids | Not applicable | - | - | - |
An organic compound that contains chlorine as a chlorine ion ionically bonded to quaternary ammonium. |
| 15 | Organic peroxides | Not applicable | - | - | - |
An organic compound that does not contain -O-O- structure. |
| 16 | Corrosive to metals | Classification not possible | - | - | - |
No established test method suitable for solid substances. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 3 |
 |
H301 |
P301+P310 P264 P270 P321 P330 P405 P501 |
It was classified in Category 3 which is the higher hazard between two LD50 values for rats (304.5 mg/kg (EPA RED (2006)) and 240 mg/kg (PIM G022 (1999), corresponding to List 1)), one of which corresponds to Category 3 and another corresponds to Category 4. |
| 1 | Acute toxicity （Dermal） | Category 3 |
|
H311 |
P302+P352 P280 P312 P322 P361 P363 P405 P501 |
It was classified in Category 3 which is the higher hazard between two LD50 values for rats (930 mg/kg (EPA RED (2006)) and 1560 mg/kg bw (PIM G022 (1999))), one of which corresponds to Category 3 and another corresponds to Category 4. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - |
"Solids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - |
No data. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Category 2 |
|
H330 |
P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501 |
On the basis of an LC50 value of 53 mg/m3/4h = 0.053 mg/L/4h for rats (HSDB (2010)), it was classified in Category 2. Besides, a reference value of dust/mist was applied from the description of exposure to "aerosol" (HSDB (2010)). |
| 2 | Skin corrosion/irritation | Category 1 |
 |
H314 |
P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501 |
It was classified in Category 1 from a "corrosive" result in a test using rabbits (EPA RED (2006)) and the information that necrosis was observed at concentrations of 1% or higher in tests applied aqueous solutions to rabbits and guinea pigs (HSDB (2010)). |
| 3 | Serious eye damage/eye irritation | Category 1 |
|
H318 |
P305+P351+P338 P280 P310 |
In a test applied 0.1 mL of 10% solution of this substance into the conjunctival sac of three rabbits (OECD TG 405; GLP), severe damage in the cornea, iris, and conjunctiva occurred in all animals, the severe damage in the cornea and iris lasted until the end of a 21-day observation period, and MMAS (irritation score: equivalent to AOI) was 108 (maximum 110) (ECETOC 48 (1998)). Therefore, it was classified in Category 1. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - |
No data. |
| 4 | Skin sensitization | Category 1 |
 |
H317 |
P302+P352 P333+P313 P261 P272 P280 P321 P363 P501 |
It was reported that two physicians were sensitized to this substance from handling instruments soaked in a disinfectant containing this substance and developed allergic conjunctivitis from eye drops containing this substance. (PIM G022 (1999)) This substance is the acknowledged cause of allergic contact dermatitis, and it is also reported that all six patients who had a history of using a skin emollient containing this substance and presented with flexural eczema, were identified as a type 4 allergy in a patch test. (HSDB (2010)) Furthermore, this substance is listed as a sensitizing substance in "Contact Dermatitis (Frosch) (4th, 2006)" (corresponding to List 1). Therefore it was classified in Category 1. |
| 5 | Germ cell mutagenicity | Not classified | - | - | - |
From a negative result in a micronucleus test using mice (in vivo mutagenicity test) (EPA RED (2006)) (EMEA (1997), corresponding to List 2), it was classified as "Not classified." Besides, as in vitro tests, a negative in an Ames test (NTP DB (1984); EPA RED (2006)) and a positive in a micronucleus test using human lymphocytes (HSDB (2010)) were reported. |
| 6 | Carcinogenicity | Not classified | - | - | - |
In a diet administrated carcinogenicity test in rats and mice, evidence of carcinogenicity was not found in either animal species. (EPA RED (2006)) And it is concluded that this substance, for which the database for carcinogenicity is complete, is not carcinogenic based on studies in rats and mice. (EPA RED (2006)) Therefore, it was classified as "Not classified." Besides, it was reported that no evidence of carcinogenicity was obtained in a diet administration test in rats for two years or in guinea pigs for one year (EMEA (1997)) and no tumors were observed in dermal administration in mice and rabbits for 80 weeks. (HSDB (2010)) |
| 7 | Reproductive toxicity | Category 2 |
 |
H361 |
P308+P313 P201 P202 P281 P405 P501 |
In a developmental toxicity test in which mice were orally administrated from day 0 to 6 of gestation, significant and dose-dependent decreases in a pregnancy rate, an implantation number, and a fetus number at 3 mg/kg bw/day or higher were shown. (EMEA (1997)) But it was classified in Category 2 due to no description of general toxicity in maternal animals. Besides, in vaginal administration on day 1 of gestation in rats, a statistically significant and dose-dependent decrease in mean fetus numbers in addition to a decrease in maternal body weights at 100 mg/kg or higher was observed. Furthermore, a significant decrease in implantation numbers in the highest dose group (200 mg/kg) was indicated. (HSDB (2010)) But adverse effects on sexual function and fertility were not reported in a two-generation diet administration test in rats. (USEPA/HPV (2001)) |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (lung) |
|
H371 |
P309+P311 P260 P264 P270 P405 P501 |
Rats showed increased lung weights, severe inflammations and irritations in the lung after inhalation exposure to 0.03 mg/L (mists) for 6 hours (converted to a 4-hour equivalent value: 0.045 mg/L) (HSDB (2010)). It corresponds to Category 1 by judging from Guidance values, but it was classified in Category 2 (lung) in accordance with Guidance because data are from List 2 and do not meet Decision Criteria 1b3) (an OECD TG test that is according to GLP and has some degree of approval). Besides, it was reported that both of two-and-a-half-month-old twins mistakenly and orally ingested an 11% solution of this substance developed fever, dehydration, cough, salivation, and numerous oral and pharyngeal lesions within 24 hours and recovered by treatments, though one of them developed chemical pneumonia. (PIM G022 (1999)) |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible | - | - | - |
In a 12-week repeated oral administration test in rats, deaths of two animals and a decrease in weight gain around the upper limit of a range in Guidance values (100 mg/kg/day) were observed but adverse effects on changes in other test parameters including pathological tests were not reported. (HSDB (2010)) Due to this data from a test in males only and no description of a cause of deaths, the classification is not possible. Besides, in a 52-week oral administration test in dogs dosed at 12.5 to 50 mg/kg/day, systemic effects were not observed except for those in the digestive tracts such as hyperemia and inflammations of the stomach and small intestine as local effects. (HSDB (2010)) But it cannot be a basis for the classification (as "Not classified") because doses are within a range of Guidance values. On the other hand, in a 3-month dermal administration test in rats at 10 mg/kg/day, changes in blood cell parameters and damage in liver and kidney were mentioned (EMEA (1997)), but more details are not described and unknown. Furthermore, in a 14-week inhalation exposure test to rats at 0.0099 mg/L, it was reported that effects were not observed (HSDB (2010)), but it cannot be used as a basis for the classification (as "Not classified") because the concentration is within a range of Guidance values. From the above, it was classified as "Classification not possible" due to lack of data in each oral, dermal and inhalation route. |
| 10 | Aspiration hazard | Classification not possible | - | - | - |
No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Category 1 |
 |
H400 |
P273 P391 P501 |
It was classified in Category 1 from 48-hour EC50 = 0.018 mg/L for crustacea (Daphnia magna) (AQUIRE, 2012; HSDB, 2011). |
| 11 | Hazardous to the aquatic environment （Long-term） | Category 1 |
|
H410 |
P273 P391 P501 |
Reliable chronic toxicity data were not obtained. Due to lack of rapid degradability (BIOWIN), and acute toxicity Category 1, it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - |
This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* 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. |
Updated date:
|
2017/3/17 Addition of Rationale for the classification |