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

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 121-79-9
Chemical Name Propyl 3,4,5-trihydroxybenzoate
Substance ID m-nite-121-79-9_v1
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) To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link) To Workplace Safety Site (MHLW)
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 Classification not possible
-
-
- - No data. 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 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) 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). FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Dermal) Classification not possible
-
-
- - No data. 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
-
-
- - No data. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
2 Skin corrosion/irritation Classification not possible
-
-
- - No data. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Serious eye damage/eye irritation Classification not possible
-
-
- - No data. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Respiratory sensitization Classification not possible
-
-
- - No data. 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
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)).
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
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.
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
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.
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
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.
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
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.
FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
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.
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) Classification not possible
-
-
- - No data. FY2011 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Hazardous to the aquatic environment Long term (Chronic) Classification not possible
-
-
- - No data. 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.

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