GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 121-79-9
Chemical name Propyl 3,4,5-trihydroxybenzoate
Substance ID 23A5083
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 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 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) Not classified - - - From LD50 values of 3800 mg/kg and 3600 mg/kg for rats (JECFA 784 (1993)), it was classified as "Not classified" in JIS classification (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Classification not possible - - - No data.
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 - - - No data.
2 Skin corrosion/irritation Classification not possible - - - No data.
3 Serious eye damage/eye irritation Classification not possible - - - No data.
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Category 1

Warning
H317
P302+P352
P333+P313
P261
P272
P280
P321
P363
P501
Complaints about pruritus and erythema in humans who received applications of a preparation containing this substance of 20% to their forearms, cases of allergic contact cheilitis in humans using lipsticks containing this substance, and a case of a subject who developed eczema after using a preparation containing this substance to an arm showed a positive for this substance in a patch test were reported. (PATTY (5th, 2001))
This substance is listed as an allergy substance in Contact Dermatitis (Frosch) (Contact Dermatitis (4th, 2006), corresponding to List 1).
From the above, it was classified in Category 1.
Besides, it is classified in R43 in EU classification (EC-JRC (ESIS) (Access on June 2011)).
5 Germ cell mutagenicity Not classified - - - From a negative result in a dominant lethal test by oral administration in rats (in vivo heritable germ cell mutagenicity test) (JECFA 784 (1993)) and a negative result in a micronucleus test using bone marrow and peripheral blood after intraperitoneal administration in mice (in vivo somatic cell mutagenicity test) (JECFA 784 (1993), NTP DB (Access on June 2011)), it was classified as "Not classified."
Besides, an obtained positive result in a micronucleus test using bone marrow after intraperitoneal administration in mice (in vivo somatic cell mutagenicity test) (PATTY (5th, 2001)) was judged not to be biologically reproducible.
Furthermore, as in vitro tests, an approximate negative in an Ames test (NTP DB (1981), PATTY (5th, 2001)) despite positives in a mouse lymphoma test and a chromosomal aberration test using CHO cells (NTP DB (Access on June 2011)) were reported.
6 Carcinogenicity Not classified - - - It was classified as "Not classified" from the conclusion that carcinogenicity was not found in both animal species in a 2-year diet administration test at concentrations of 6000 and 12000 ppm in rats and mice (NTP TR 240 (1982)).
Besides, rats showed increased incidences in preputial gland tumors, islet cell tumors of the pancreas, pheochromocytoma of the adrenal glands in males in a low dose, rare brain tumors in females in a low-dose group, but a high-dose group did not show.
And significantly increased incidences of malignant lymphoma compared to a control group shown in mice in a high-dose group were not significantly different from the background control data for the testing facility.
7 Reproductive toxicity Classification not possible - - - A 2-generation diet administration reproductive test in rats reported that fertility and reproduction parameters were not affected and no abnormalities were observed in the organs or tissues in necropsy. (JECFA 784 (1993))
Besides, no effects on an organogenetic period in rabbits were described (PATTY (5th, 2001)) without mentioning specific test methods and data.
Therefore, it was classified as "Classification not possible" due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible - - - In a single oral administration test at doses of 125 to 2000 mg/kg in rats and mice, slight inactivity in addition to deaths (a part of animals) was observed in mice in a high-dose, but no other dose-related effects were reported in both animal species. (NTP TR 240 (1982))
This test did not include necropsy and histological tests in test items because it was conducted as a preliminary test for a repeated administration test.
Therefore it was classified as "Classification not possible" due to lack of data.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - There are two 13-week diet administration tests using rats.
The first test reported effects on the stomach such as necrosis and ulceration of the mucosal surface, and granulomatous inflammatory response in the submucosa and muscular wall at a high dose of 25000 ppm (1250 mg/kg/day) but no effects at doses of 6000 ppm (300 mg/kg/day) or lower. (NTP TR 240 (1982))
The second test reported changes in hematological parameters and spleen at a high dose of 7455 ppm (ca. 1000 mg/kg/day) but no toxic effects at 1910 ppm (135 mg/kg/day) determined to be NOAEL. (JECFA 784 (1993))
The NOAEL above the upper limit of a range of Guidance values (100 mg/kg/day) corresponds to "Not classified" in an oral route from the above, but it was classified as "Classification not possible" in specific target organ toxicity (repeated exposure) because effects in other routes (inhalation, dermal) are unknown due to no data.
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) Classification not possible - - - No data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - No data.
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.
* 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.

Updated date:
  2017/3/31 Addition of Rationale for the classification

List of GHS Classification Results