GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 19715-19-6
Chemical name 3,5-Di-tert-butylsalicylic acid
Substance ID 23A5183
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) Category 4

Warning
H302
P301+P312
P264
P270
P330
P501
From an LD50 value of 460 mg/kg bw for rats (Reproductive test, METI (2008), equivalent to List 2), it was classified in Category 4.
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 Classification not possible - - - No data.
5 Germ cell mutagenicity Classification not possible - - - No data.
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Classification not possible - - - In an oral combined repeated dose toxicity study with reproductive/developmental toxicity screening test (OECD TG 422, GLP) in rats, a low-value tendency in a delivery index and numbers of pups born and alive pups born but no significant changes in numbers of corpora lutea and implantation, and implantation index were observed.
And dose-related changes in sex cycle, copulation index, fertility index, the length of gestation, observations in deliveries and nursing in parent animals, and an external test and necropsy in neonates were not observed.
Due to data from List 2, no description of statistical significance of a low-value tendency in numbers of pups born and alive pups born, and insufficient assessment of fetal teratogenicity, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Classification not possible - - - No data.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - In an oral combined repeated dose toxicity study with reproductive/developmental toxicity screening test (OECD TG 422, GLP) (doses: 0, 4, 20, 100 mg/kg/day) in rats, the 100 mg/kg group showed transient salivation, high values in ALAT and triglyceride in a blood biochemical test, and a high value in liver weights.
But the signs were reversible and the test observed neither related changes in a histopathological test nor other dose-related changes (METI reproductive test (2008). Therefore, NOAEL was reported to be 100 mg/kg/day (converted to a 90-day equivalent value: about 50 mg/kg/day).
Because the highest dose is still within a range of Guidance values and there are no data above the upper limit of Guidance values, it was classified as "Classification not possible."
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 2 No pictogram
No signal word
H401
P273
P501
It was classified in Category 2 from 96-hour LC50 = 2.7 mg/L for fish (Oryzias latipes) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, (2006), and so on.
11 Hazardous to the aquatic environment (Long-term) Category 2

No signal word
H411
P273
P391
P501
If chronic toxicity data are used, then it is classified in Category 2 from non-rapidly degradable (a degradation rate by BOD: 0 % (the existing chemicals survey program, 2003)) and 72-hour NOEC = 0.87 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Ecotoxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2006).
If acute toxicity data are used for trophic levels for which chronic toxicity data are lacking, then it is classified in Category 2 from non-rapidly degradable (a degradation rate by BOD: 0 % (the existing chemicals survey program, 2003)) and 96-hour LC50 = 2.7 mg/L for fish (Oryzias latipes) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2006).
From the above results, it was classified in Category 2.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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:
2016/10/31 Addition of Rationale for the classification

List of GHS Classification Results