GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 69-72-7
Chemical name Salicylic acid
Substance ID 23A5069
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

REFERENCE INFORMATION

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

PHYSICAL HAZARDS

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 Not classified - - - It is conceivable that it does not ignite at normal temperatures from an ignition point of 540 degrees C (HSDB (2009)).
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 does not contain fluorine or chlorine but contains oxygen which is not chemically bonded to elements other than carbon or hydrogen.
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.

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
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.
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."
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) 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)).
2 Skin corrosion/irritation Category 2

Warning
H315
P302+P352
P332+P313
P264
P280
P321
P362
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.
3 Serious eye damage/eye irritation Category 2A

Warning
H319
P305+P351+P338
P337+P313
P264
P280
Because dropping a 3% solution into rabbit eyes resulted in a "highly irritating" (IUCLID (2000)), it was classified in Category 2A.
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))
4 Skin sensitization Category 1

Warning
H317
P302+P352
P333+P313
P261
P272
P280
P321
P363
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)).
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))
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Category 2

Warning
H361
P308+P313
P201
P202
P281
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)
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system)

Danger
H370

P307+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.
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).
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

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 3 No pictogram

No signal word
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).
11 Hazardous to the aquatic environment (Long-term) 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."
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

List of GHS Classification Results