GHS Classification Result (Revision of the past classification result)

Chemical Name:4,4'-Thiobis(6-tert-butyl-3-methylphenol)
CAS:96-69-5

Result:
ID: 21B3042
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solids Classification not possible - - - - No data available.
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 - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Based on LD50 values of approximately 5000 mg/kg (ACGIH (2001)) and 5000 - 7000 mg/kg (NTP TR435 (1994)) for rats, the substance was classified into "Not classified".
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - There is a report of positive responses in patch tests for 2 patients with contact dermatitis caused by rubber gloves which contain this substance (ACGIH (2001)). No additional care reports are not available. Classification was not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible - - - - Classification not possible due to lack of data from in vivo mutagenicity tests. From in vitro mutagenicity tests, there are reports of a negative Ames test and a negative CHO cell chromosomal aberration test ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2006), ACGIH (2001)).
6 Carcinogenicity Not classified - - - - Based on the classification of "A4" in ACGIH (ACGIH-TLV (2005)), the substance was classified as "Not classified". In 2-year feeding tests in rats and mice, there was no evidence of carcinogenic activity in either species (NTP TR435 (1994)).
7 Reproductive toxicity Classification not possible - - - - Although there is a report that by oral administration to pregnant mice during organogenesis period, the substance caused maternal mortality and a decreased rate of survival of pups, but had no effect on the number of viable litters, litter size, pup birth weight, or pup weight gain (NTP TR435 (1994)), test details are unknown. Classification not possible due to a lack of sufficient data.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Although there is a report that in acute oral toxicity tests in rats, the LD50 value is between 5000 and 7000 mg/kg and the rats exhibited severe diarrhea preceding death (NTP TR435 (1994)), classification was not possible due to lack of sufficient data.
9 Specific target organ toxicity - Repeated exposure Category 2 (liver) Warning H373: May cause damage to organs through prolonged or repeated exposure (liver) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In a 28-day repeated oral dose test in rats, effects on the intestine were observed at dose levels of 60 mg/kg/day and higher. Effects on the liver were noted at a dose level of 250 mg/kg/day (90-day equivalence: 77.8 mg/kg/day) ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2006)). In 13-week and 2-year feeding tests in rats and mice (NTP TR435 (1994)), the following effects were observed: increased serum hepatic enzymes, ALP and GOT levels; histopathological finding in the liver including hypertrophy of Kupffer cells, bile duct hyperplasia, and individual cell necrosis of hepatocytes; hematological changes in erythrocyte count, hemoglobin concentration and hematocrit level; pigmentation and degeneration of the renal cortical tubule epithelial cells; and increase in size and number of macrophages in the mesenteric lymph nodes. These findings were observed at high dose levels exceeding the upper limit of the guidance value range. The effects on the kidney were reported in some tests only, but the effects on the liver were observed in all 5 tests including the 28-day oral test in rats. In the 2-year feeding test in rats, histopathological changes including Kupffer cell hypertrophy, hepatocyte cytoplasmic vacuolization, mixed cell foci, and basophilic foci and remarkable increase in serum GOT were observed at 2500 ppm (100 - 120 mg/kg/day). It is reported that the increases in ALP at dose levels of 1000 ppm (40 - 45 mg/kg/day) and higher are indicative of disturbances involving the hepatobiliary system (NTP TR435 (1994)). Based on the data, the substance was classified into Category 2 (liver).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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