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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	132-27-4
Chemical Name	Sodium 1,1'-biphenyl-2-olate
Substance ID	H28-B-070, C-149B
Classification year (FY)	FY2016
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
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 Signal word	Hazard statement (code)	Precautionary statement (code)	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	- -	-	-	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	- -	-	-	Test methods applicable to solid substances (melting point <= 140 deg C) (melting point 78 deg C (Gangolli (1995))) are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metal (Na), but it is estimated that it does not react vigorously with water due to the observation result of being very soluble in water (DFGOT vol.2 (1991)).
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 ionically bonded to the element other than carbon or hydrogen (Na) and does not contribute to oxidation due to an ionic bond.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the LD50 values of 846 mg/kg (male), 591 mg/kg (female) (EPA RED (2006)), and 1,000-1,600 mg/kg (DFGOT vol.2 (1991)), this substance was classified in Category 4.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	It is reported that in humans, severe irritation by a 1% solution (pH 11.2-11.6) (PATTY (6th, 2012)), or severe irritation by a 1% or 5% solution was observed on humans (DFGOT vol.2 (1991)). In addition, it is reported that although details are unknown, also in a skin irritation test using rabbits, severe irritation was observed (JMPR (1999)). Since even for a 1% solution, pH is around 11.5, and severe irritation was observed, it was classified in Category 1.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is reported that severe irritation by a 1% solution (pH 11.2-11.6) (PATTY (6th, 2012)) or corneal necrosis by a 0.5% solution (DFGOT vol.2 (1991)) was observed in humans. In addition, it is reported that although details are unknown, also in an eye irritation test using rabbits, moderate irritation was observed (JMPR (1999)). Since it suggests a possibility of corrosiveness, this substance was classified in Category 1.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	It is reported that in a skin sensitization test (Buhler test) using guinea pigs, it was negative (PATTY (6th, 2012)). In addition, it is described that in a patch test (0.1-5% aqueous solutions) in humans (100 males and 100 females), it was not sensitizing (PATTY (6th, 2012)). Moreover, although details are unknown, it is reported that in a skin sensitization test (details unknown) using guinea pigs, it was negative (EPA RED (2006)), and there is an assessment that there was no skin sensitization in guinea pigs and humans (JMPR (1999)). Therefore, this substance was classified as "Not classified."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, dominant lethal tests using rats and mice and chromosomal aberration test using bone marrow cells of rats were negative, DNA damage tests using rats and mice resulted in positive and negative (IARC 73 (1999)). As for in vitro, bacterial reverse mutation tests were negative, a mammalian cell gene mutation test and a mouse lymphoma test were positive, chromosomal aberration tests were positive, and sister chromatid exchange tests resulted in positive and negative (IARC 73 (1999), DFGOT vol.2 (1991), NTP TR301 (1986), NTP DB (Access on October 2016)). Although there were positive results in in-vivo somatic cell genotoxicity tests, reproducibility was not observed.
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	There are reports from 2 carcinogenicity studies using rats dosed by feeding and one carcinogenicity study using mice dosed by feeding. In 2 studies in rats, increased incidence of urinary bladder tumors was significantly observed in males (IARC 73 (1999), PATTY (6th, 2012)). On the other hand, there was no evidence of carcinogenicity in mice. IARC classified it in Group 2B because there is sufficient evidence of carcinogenicity in experimental animals (IARC 73 (1999)). Therefore, it was classified in Category 2 for this hazard class.
7	Reproductive toxicity	Not classified	- -	-	-	In a 2-generation study using rats given the free base of this substance (ortho-Phenylphenol: OPP) by feeding administration, at the high dose of 500 mg/kg/day, general toxic effects in parental animals (reduction in body weights in males and females, urine staining bladder in males, bladder calculi in males, and histological changes in the kidneys, bladder, and ureter of males) were observed, but no effects on fertility were observed (PATTY (6th, 2012)). In the developmental toxicity studies using pregnant rats or pregnant rabbits given OPP by gavage (rats: days 6-15 of gestation, rabbits: days 7-19 of gestation), no abnormality was found in the fetuses, at up to 700 mg/kg/day in rats where weight gain suppression and food intake reduction were observed as maternal toxicity, and at up to 250 mg/kg/day in rabbits where deaths (13%), gross findings of the gastrointestinal tract, and histopathological changes in the kidney were observed as maternal toxicity (PATTY (6th, 2012)). Moreover, even in a study in which pregnant mice were given this substance at up to 400 mg/kg/day or OPP at up to 2,100 mg/kg/day by gavage on days 7-15 of gestation, only lower body weights were observed in both maternal animals and fetuses (DFGOT vol. 2 (1991)). As above, even when the free base of this substance was orally administered to experimental animals at high doses, only general toxic effects were manifested, and reproductive developmental effects were not detected at all. Since this substance, a sodium salt of OPP, is also considered to dissociate readily in the body to produce OPP, this substance was classified as "Not classified" for this hazard class.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	There is no single exposure data of this substance in humans. In the previous classification, it was classified in Category 3 (narcotic effects) based on the description that narcosis and low respiration rate were observed in single oral dose studies in rats and mice (DFGOT vol. 2 (1991)). However, according to the 3 original articles, in rats, described symptoms are as follows: sedation, lacrimation, abnormal breath sound, premortal decreased respiration (Tayama et al., Annual Report of Tokyo Metropolitan Research Laboratory of Public Health 57, 30-2 (1979)); and decrease in motor activity, staggering gait, decreased respiration, and hypothermia and tremor at the high doses where is above lethal dose (Taniguchi et al., Nara Igaku Zasshi 32, 709 (1981)). In mice, crouching position and abnormal vocalization were observed (Ogata et al., Annual Report of Tokyo Metropolitan Research Laboratory of Public Health 54, 30-2 (1979)). These symptoms were observed at or above 1,000-1,500 mg/kg, which is equivalent to Category 2. However, since these findings may include nonspecific effects that are premortal or at the high doses above a lethal dose, it was considered to be difficult to classify it as the central nervous system or narcotic effects. Since there was no other information available for the evidence of classification, it was classified as "Classification not possible." The classification result was changed from the previous classification by investigation of the information sources.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is no information on humans. As for experimental animals, the repeated dose toxicity studies using rats, mice, guinea pigs, and hamsters dosed by feeding were conducted. The lesions in urinary bladder and kidney were observed only in rats (DFGOT vol.2 (1991), IARC 73 (1999)). In a 3-month repeated dose toxicity study using rats dosed by feeding at 2% (1,000-1,500 mg/kg/day), from 1-2 weeks, hyperplasia of the bladder epithelium was observed, by adopting the study of 2 weeks or more according to the GHS classification guidance for the Japanese Government, converted guidance values were 156-233 mg/kg/day (DFGOT vol.2 (1991)). In addition, in another 3-month repeated dose toxicity study, pyelonephritis was observed in males of the 4.0% (2,450 mg/kg/day) group, which is a dose above Category 2 (DFGOT vol.2 (1991)). Moreover, in 8 to 24-week repeated dose toxicity study, at 2% which is above Category 2 (converted guidance value: 1,000 mg/kg/day), increase in urinary pH and sodium concentrations, simple and nodular or papillary hyperplasia of the bladder epithelium were observed at all times (8, 16, 24 weeks) (IARC 73 (1999)). From the above, lesions were observed in the urinary bladder and kidney, but since they were observed at the doses above Category 2, it was classified as "Classification not possible."
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 2	- -	H401	P273 P501	From 48-hour EC50 = 3.2 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)), it was classified in Category 2.
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 because appropriate data on rapid degradability are not obtained, and 21-day NOEC (reproduction) = 0.6 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because appropriate data on rapid degradability are not obtained, and 96-hour LC50 = 7.0 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)). It was classified in Category 2 by drawing a comparison between the above results.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

NOTE:

* 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.

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