NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	69-72-7
Chemical Name	Salicylic acid
Substance ID	m-nite-69-72-7_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	It is conceivable that it does not ignite at normal temperatures from an ignition point of 540 degrees C (HSDB (2009)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain fluorine or chlorine but contains oxygen which is not chemically bonded to elements other than carbon or hydrogen.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	All of five LD50 values for rats (1500 to 2000 mg/kg (JECFA WHO 228 (1962)), 1100 mg/kg (JECFA 7742 (2002)), 891 mg/kg, 1580 mg/kg, 1280 mg/kg (NTP TR524 (2007))) correspond to Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	From LD50 of >2000 mg/kg and no deaths in rats (NTP TR524 (2007)), it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	The classification is not possible because the category can not be determined from a reported LC50 value of >0.9 mg/L/1h (>0.225 mg/L/4h) for rats in exposure to dust (IUCLID (2000)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	A 21-day occlusive or semi-occlusive test applied a 0.2% or 1.5% salicylic acid solution to human concluded that this substance was nonirritating (NTP TR524 (2007)), and a test using rabbits reported that it was "slightly irritating" from an irritation score of 0.16/8.0 (IUCLID (2000)). But a test in human volunteers resulted in "irritating" (IUCLID (2000)), toxic epidermal necrosis in 13 patients associated with the use of a salicylate was reported (PIM 642 (1998), corresponding to List 1), cauterizing action in a high concentration of salicylic acid (not less than 20%) was described (IUCLID (2000)). Therefore, it was classified in Category 2.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1), it was classified in Category 1. Based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in an eye irritation test with rabbits (n=3) (21-day observation), marked irritating effects on the cornea and conjunctivae were observed and the mean scores for cornea and conjunctivae evaluated according to the Draize method were 54.1 (full score: 80) and 10.3 (full score: 20), respectively, and the effects did not fully recover within 21 days of observation (ECHA RAC Opinion (2016), CLH Report (2014), SCCS (2019), REACH registration dossier (Accessed Oct. 2021)). [Reference Data, etc.] (2) It was reported that, in an eye irritation test with rabbits (n=6) (72-hour observation), this substance induced severe irritation after 24 hours (mean score of eye irritation: 51.5/110). The severe irritation subsided after 48 hours (the same score: 40.3/110) but the effects were observed even after 72 hours (the same score: 38.7/110) (ECHA RAC Opinion (2016), CLH Report (2014), REACH registration dossier (Accessed Oct. 2021)). (3) It was reported that, in an in vitro eye irritation test using bovine cornea (BCOP assay), the opacity readings with this substance at the concentrations of 0.1%, 1%, and 10% were 7.2%, 70.2%, and 98.7%, respectively, and this substance was considered a severe irritant (ECHA RAC Opinion (2016), CLH Report (2014), SCCS (2019), REACH registration dossier (Accessed Oct. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	No data. Besides, there is information that some people particularly asthmatics, exhibit marked sensitivity to salicylate, resulting in various reactions including urticaria, eruptions, vascular neuritis, rhinitis, and severe and even fatal paroxysmal bronchospasm, dyspnea, shock, syncope and so on. (PIM 642 (1998))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	From a "positive" reported in a skin sensitization test in mice by LLNA method (NTP TR524 (2007)), it was classified in Category 1. Besides, there is information that topical using of this substance may cause allergic contact dermatitis (PIM 642 (1998)), on the other hand, a mouse ear swelling test reported "not sensitizing" (IUCLID (2000)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" from a negative in a chromosomal aberration test (in vivo mutagenicity test) after intraperitoneal or oral administration to mice the both routes of which did not show a significant increase in chromosomal aberrations (HSDB (2009)). Besides, a significant decrease in tritiated thymidine incorporation was reported in a test of tritiated thymidine incorporation into testicular DNA by oral administration to mice (in vivo germ cell mutagenicity test). (HSDB (2009)) In addition, as an in vitro test, a negative result in an Ames test was reported. (HSDB (2009); Mutagenicity test data, Industrial Safety and Health Law, Supplement vol. 2 (2000))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	A time of onset of parturition significantly increased after oral administration (10 mg/kg) on days of 20 and 21 of gestation in rats. (HSDB (2009)) Increased neonatal mortality, decreased litter size, and increased incidences in external anomalies and skeletal anomalies in the offspring in addition to the maternal body weight loss were observed in diet administration on day 8 to 14 of gestation in rats. (HSDB (2009)) From the above, reproductive effects were observed at a dose where general toxicity occurred in maternal animals, therefore, it was classified in Category 2. Besides, salicylate used as a medicine in humans compelled to avoid to using during the third trimester of pregnancy (late pregnancy) because increased prenatal mortality, antepartum and postpartum hemorrhage, prolonged pregnancy, abnormal deliveries, and so on are found. (PIM 642 (1998)) Especially, sodium salicylate injection compelled pregnant women or women anticipating pregnancy to be administration contraindication. (Ethical pharmaceuticals (2010), corresponding to List 1)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	A case report of a psoriatic patient, who developed encephalopathy followed by treatment-refractory hypoglycemia or acid-base disturbances after treatment with topical cream including this substance, recovered by emergent hemodialysis (HSDB (2009)), to begin with, multiple similar cases were reported (HSDB (2009)). Besides, it is reported that a 5-year-old child with lamellar ichthyosis showed a fever, hyperpnea, respiratory alkalosis, comatose state and oculogyric crisis after using as an ointment. (HSDB (2009)) Respiratory center stimulated by toxic doses of this substance leads respiratory alkalosis, and in severe intoxication, metabolic alkalosis. Furthermore, the central nervous system was described as one of the target organs (PIM 642 (1998)), therefore, it was classified in Category 1 (central nervous system). Besides, effects of salicylate on organs other than the central nervous system such as liver and lung were reported like a case report of hepatic encephalopathy developed in a child who took aspirin (acetylsalicylic acid) (PIM 642 (1998)), but no such reports specific to this substance itself in human were offered.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system)	Danger	H372	P260 P264 P270 P314 P501	There is a case report of a 7-year-old child with ichthyosis vulgaris treated with a 10% ointment for over four weeks, who developed wheezing, vomiting, vertigo followed by a deep somnolent state considered to be caused by hyperventilation, and was hospitalized. (PIM 642 (1998)) Furthermore, there is also a report of a psoriatic patient who developed encephalopathy after using a cream for five days and was admitted to ICU. (HSDB (2009)) On the other hand, there is information that mortality of chronic intoxication is higher than that of acute overdose and death is often due to sudden cardiac arrest or occasionally due to multiple complications following severe brain damage. (PIM 642 (1998)) Because a central nervous system is also described as one of the target organs in exposure to this substance (PIM 642 (1998)), it was classified in Category 1 (central nervous system).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour EC50 = 65mg/L for algae (Pseudokirchneriella subcapitata) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2000).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it was classified as "Not classified" from rapid degradability (a degradation rate by BOD: 88.1% (the existing chemicals survey program, 1976)) and 72-hour NOEC = 31mg/L for algae (Pseudokirchneriella subcapitata) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2000). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it was classified as "Not classified" from 96-hour LC50 => 100mg/L for fish (Oryzias latipes) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2000), rapid degradability (a degradation rate by BOD: 88.1% (the existing chemicals survey program, 1976)), and a low bioaccumulation estimate (log Kow = 2.26 (PHYSPROP Database, 2012)). From the above results, it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

To GHS Information