NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	14698-29-4
Chemical Name	Oxolinic acid
Substance ID	24A6030
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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	- -	-	-	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	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	It was classified as "Not classified" based on two LD50 values for rats (> 5,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)) and > 4,000 mg/kg (Evaluation of effect for the food safety (Food Safety Commission, 2011))).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" because it is reported that there was no death after administration of 2,000 mg/kg to rats, and an LD50 value was > 2,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
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)	Category 4	Warning	H332	P304+P340 P261 P271 P312	It was classified in Category 4 based on an LC50 value by 4-hour exposure (dust) in rats of 1.70 mg/L (females) to 2.45 mg/L (males) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
2	Skin corrosion/irritation	Not classified	- -	-	-	In a test in which 0.5 g of this substance was applied to the rabbit skin for 4 hours (GLP-compliant), no irritation reactions such as erythema and edema were observed, the primary irritation index was 0, and it was judged as not irritating to the skin (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Therefore, it was classified as "Not classified."
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In a test in which 0.1 g of this substance was applied to the rabbit eye (GLP-compliant), conjunctival flush (score 1) in two out of six animals and chemosis (score 1) in one of them were observed 1 hour after the application, but these disappeared after 24 hours. As a result, this substance was judged as not irritating to the rabbit eye (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Therefore, it was classified as "Not classified."
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Not classified	- -	-	-	In a skin sensitization test by a maximization test with guinea pigs, no local reactions such as erythema and edema were observed in the group treated with the test substance like the control group (not induced) for the test substance. On the other hand, moderate to severe erythema and edema were found in all animals in the group treated with DNCB, the positive control, but no changes were seen in the control group (not induced) for DNCB. The positive rate was 0% (0/18) in the test conditions, and oxolinic acid was judged to be not a skin sensitizer (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Therefore, it was classified as "Not classified."
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow cells after intraperitoneal administration to mice (in vivo somatic cell mutagenicity test) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). And it was also reported to be negative in a sister chromatid exchange test with bone marrow cells after oral administration to mice (in vivo somatic cell genotoxicity test) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Besides, as for in vitro tests, it is reported that it was positive in an Ames test, negative in a gene mutation test with cultured cells derived from Chinese hamsters (V79), and weakly positive in a chromosomal aberration test with CHL cells (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
6	Carcinogenicity	Classification not possible	- -	-	-	In a chronic toxicity/carcinogenicity test by 24-month diet administration to rats (0, 30, 100, 300, 1,000 ppm, GLP), a significant increase in interstitial cell tumors in the testis was observed in males in the 1,000 ppm group, but there was no other dose-related increase in the incidence of tumors (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). It is reported that by investigating the mechanism of development, the increase in the testicular tumors was most likely to be secondary carcinogenesis caused by increased LH release from the anterior lobe of the pituitary through the dopaminergic nervous system of the hypothalamus, not carcinogenesis by direct action to the testis (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Therefore, it is hard to regard it as evidence of carcinogenicity in humans. On the other hand, in an 18-month diet administration carcinogenicity test with mice (0, 50, 150, 500 ppm, GLP), no incidences of tumors significantly increased in any dose group, and it was judged to be not carcinogenic (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). From the above, it was judged to be not carcinogenic in two animal species of rats and mice, but both were List 2 data. Therefore, it was classified as "Classification not possible," not as "Not classified."
7	Reproductive toxicity	Classification not possible	- -	-	-	In a two-generation breeding test by diet administration to rats (GLP-compliant), reduced weight gain and decreased food consumption were observed in parent animals, but no fertility effects occurred (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). And in a developmental toxicity test by oral administration to rats during the organogenesis period (GLP-compliant), no fetotoxicity or teratogenicity was found at the doses that caused maternal toxicity (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)), and also in a developmental toxicity test by oral administration to rabbits during the organogenesis period (GLP-compliant), no effects were seen in maternal animals or fetuses at up to 2,000 mg/kg/day (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). From the above, because no adverse effects on sexual function, fertility, or the development of offspring were shown, it was judged not to have reproductive toxicity, but all were List 2 data. Therefore, it was classified as "Classification not possible," not as "Not classified."
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In an acute oral toxicity test with rats (GLP), deaths and bite wounds by self-biting in the forelimb, hindlimb, chest, and abdomen were observed in both males and females at or above 500 mg/kg (corresponding to the guidance values for Category 2). Because bleeding from the injured sites was considered to be the cause of death, protective devices for self-biting were installed, then no deaths were seen even at 5,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Stereotypical behavior including self-biting behavior and increased motor activity were found after the administration of high doses to rats and mice, the involvement of the dopaminergic nervous system was considered as the mechanism of inducing self-biting behavior, and it was suggested that self-biting behavior might occur as one of stereotypical behavior by activating the catecholaminergic nervous system in the brain (Evaluation of effect for the food safety (Food Safety Commission, 2011)). It was classified in Category 2 (central nervous system) based on the above knowledge. Besides, self-biting behavior was also found after inhalation exposure (dust) in rats at doses equivalent to Category 2, but it was not reported in dermal administration (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system)	Warning	H373	P260 P314 P501	In a 90-day diet administration test with rats, excitatory nervous symptoms and behavioral changes were observed in males in the 1,800 ppm dose group (132 mg/kg/day) and females in the groups at or above 300 ppm (24.4 mg/kg/day) (Evaluation of effect for the food safety (Food Safety Commission, 2011)), and it is reported that in a 6-month diet administration test with rats, neurological signs suggesting self-attacking such as biting fingers and wandering in the cage were found in the groups at or above 3,000 ppm (67-78 mg/kg/day) (Evaluation of effect for the food safety (Food Safety Commission, 2011)). Because doses that caused symptoms included the guidance value range for Category 2, it was classified in Category 2 (nervous system). Besides, variations in blood biochemical parameters reported in 13-week diet administration tests with rats and mice (GLP) were not used for the rationale for classification because no changes that histopathologically support these were seen in either test (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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	It was classified in Category 2 from 48-hour EC50 = 4.6 mg/L for crustacea (Daphnia magna) (AQUIRE, 2012).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	It was classified in Category 2 due to its being not rapidly degradable (BIOWIN), and 21-day NOEC = 0.38 mg/L for crustacea (Daphnia magna) (AQUIRE, 2012).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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