NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	646-06-0
Chemical Name	1,3-Dioxolane
Substance ID	m-nite-646-06-0_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Based on a flash point of -5 deg C (closed cup), and a boiling point of 74 deg C (GESTIS (Access on June 2017)), it was classified in Category 2. Besides, it is classified in Class 3, PGII in UNRTDG (UN 1166).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 245 deg C (GESTIS (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	Based on reported LD50 values for rats of 5,200 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011), HSDB (Access on June 2017)), and 5,800 mg/kg (HSDB (Access on June 2017)), it was classified as "Not classified." Since the data of RTECS (2004) used in the previous classification was from the information source in List 3, it was not used. The category was changed from the previous classification due to the adoption of the new information source.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a reported LD50 value for rabbits of 8,480 mg/kg (HSDB (Access on June 2017)), and 15,000 mg/kg (HSDB (Access on June 2017)), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified	- -	-	-	Based on reported LC50 values of 4-hour inhalation exposure tests with rats of 22,574 ppm (ACGIH (7th, 2002)), 28,710 ppm (ACGIH (7th, 2002)), 68.4 mg/L (22,572 ppm) (HSDB (Access on June 2017)), and 87 mg/L (28,710 ppm) (HSDB (Access on June 2017)), it was classified as "Not classified." Besides, since the LC50 values are lower than 90% of the saturated vapour pressure (104,264 ppm), a reference value in the unit of ppm was applied as vapour with little mist.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on a description that it was irritating to the skin in humans (Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)), and a report that in a skin irritation test with rabbits, it caused mild erythema and edema on intact and abraded skin (ACGIH (7th, 2002)), it was classified as "Not classified" (Category 3 in UN GHS classification).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Based on a description that it was severely irritating to the eyes in humans (Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)), and a report that in an eye irritation test with rabbits, it caused conjunctival redness, corneal ulcers and opacity, iris irritation, and conjunctival edema, and these lesions remained even after 72 hours, and the severity score was 8 out of 10 grades (ACGIH (7th, 2002)), it was classified in Category 2A.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	In a skin sensitization test with rabbits, there was a statement that irritation was observed when the skin was repeatedly exposed, but allergic dermatitis was not observed (ACGIH (7th, 2002)). However, since it was only one case, and details on the experimental conditions and the results were unclear, it was classified as "Classification not possible." The information source was reviewed, and the classification result was changed.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, there are reports that it was negative in dominant lethal tests with rats, and negative (GLP compliance test) (HSDB (Access on June 2017)) and positive (one case) (ACGIH (7th, 2002), HSDB (Access on June 2017)) in micronucleus tests with mouse bone marrow cells. As for in vitro, it was negative in all of the bacterial reverse mutation tests, and a mouse lymphoma test and a chromosomal aberration test with mammalian cultured cells (ACGIH (7th, 2002), HSDB (Access on June 2017)). From the above, since the negative result was obtained in the in-vivo mouse micronucleus test, which was conducted according to GLP, it was judged that the result of the micronucleus test was negative, so it was classified as "Classification not possible" in accordance with the GHS classification guidance for the Japanese government. The positive result in the in vivo mouse micronucleus test which was described in the previous classification was reviewed, and it was judged as appropriate that the micronucleus test result was negative. Therefore, the category was changed.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There are reports that in a study in which male rats were orally dosed at 580 and 1,160 mg/kg/day for 8 weeks during the mating period or exposed by inhalation at 825 ppm for 12 months, and the male fertility index was examined, in either route of exposure, focal necrosis of the testicular seminiferous epithelium and abnormalities of spermatogenesis were observed, but no effects on the fertility index were found (ACGIH (7th, 2002), HSDB (Access on June 2017)), and that male rats were mated with untreated females after being exposed by inhalation at 125 ppm for 90 days (exposure continued during the mating period); whereas female rats were exposed during the mating period, until 1 or 2 days before delivery, and 120 times (125 ppm, 5 days/week) after delivery, and then they were mated with the males again. However, no effects were seen in the pups until weaning (ACGIH (7th, 2002), HSDB (Access on June 2017)). In addition, there is a report that in a reproductive toxicity study in which it was administered by drinking water at the concentration of 0.5% or 1%, to males from 90 days before mating until the mating period, and to females from the mating period until 10 days after weaning, a decrease in the copulation rate and the parturition rate, an increase in the number of stillborn and a decrease in the survival rate of the pups were observed at 0.5% (approximately 500 mg/kg/day) or more, and suppression of body weight gain was observed in the maternal animals at 1% (approximately 1,000 mg/kg/day) (Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011), HSDB (Access on June 2017)). Also as for a developmental toxicity test, it is reported that in a test in which pregnant rats were dosed by gavage at a maximum of 1,150 mg/kg/day on day 8-20 of gestation, at 1,150 mg/kg/day where suppression of body weight gain was observed in the maternal animals, only slight effects (lower value of the fetal weight and crown-rump length, delayed ossification) in the fetuses were observed (ACGIH (7th, 2002), HSDB (Access on June 2017)). On the other hand, there is a report that in a test in which pregnant rats were dosed by gavage at up to 1,000 mg/kg/day on day 6-15 of gestation, suppressed body weight gain at or above 500 mg/kg/day in maternal animals, and lower value of body weight and increased incidences of malformations of the tail, heart, and vertebra at 1,000 mg/kg/day in fetuses were observed (Environmental Risk Assessment for Chemical Substances Vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011), HSDB (Access on June 2017)). From the above, regarding reproductive effects and developmental effects in experimental animals, there are reports that it was negative, while there are reports that it has clear effects, therefore, it was judged as appropriate that it was classified in Category 2 for this hazard class.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	There is no information on single exposure to this substance in humans. In experimental animals, there is a report that in a single oral administration test with rats, a decrease in a respiration rate, and a decrease in motor activity at 2,500 mg/kg exceeding the range for Category 2, and tremors, piloerection, and prostration in addition to the above symptoms at 3,500 mg/kg were observed (HSDB (Access on June 2017)). In addition, there is a report that in a 4-hour single inhalation exposure test with rats, respiratory and neuromuscular abnormalities were observed during exposure and during the observation period of 4 hours after exposure, and at necropsy, discoloration of the lung and liver was observed. Although there is no detailed description of the dose at which these symptoms were observed in this test, the LC50 value was reported as 68.4 mg/L (22,572 ppm), which was above Category 2, so the effects were thought to be seen around the LC50 value exceeding Category 2 (ACGIH (7th, 2002), HSDB (Access on June 2017)). Since the dose at which the toxic effects were observed in either of routes was a level exceeding the range for Category 2, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No information on humans is available. In a 13-week inhalation toxicity test (6 hours/day, 5 days/week) with rats, a decrease in the leucocyte count, a decrease in the spleen weight, and an increase in the relative liver weight at or above 1,000 ppm (converted guidance value: 2.19 mg/L) exceeding the guidance value range (vapour) for Category 2, and a decrease in agility, minor swelling of centrilobular hepatocytes and eosinophilia of cytoplasm in the liver at 3,000 ppm (converted guidance value: 6.57 mg/L) were observed. Also, in a 14-day repeated dose toxicity test with rats dosed by gavage, suppressed body weight gain and decrease in the platelet count at or above 250 mg/kg/day (converted guidance value: 38.9 mg/kg/day) within the guidance value for Category 2, an increase of relative liver weight, and a decrease in relative weight of the spleen and thymus at or above 750 mg/kg/day (converted guidance value: 116.7 mg/kg/day) exceeding the guidance value range for Category 2, and death, increased relative kidney weight, hypertrophy/vacuolation of the hepatocytes, thymic atrophy, and an increase in basophils in the cortical renal tubules, dilatation, and acute pyelitis in the kidney, etc. at 2,000 mg/kg/day (converted guidance value: 311.1 mg/kg/day) were observed (Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). From the above, since the effects seen within the guidance value range for Category 2 were insufficient for evidence for classification, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Not classified	- -	-	-	From 48-hour EC50 = 6,950 mg/L for crustacea (Daphnia magna), and 96-hour LC50 = 10,000 mg/L for fish (Cyprinodon variegatus) (both EPA AQUIRE: 2017, Walton, J. R. et al. (1980)), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 2 % (J-CHECK, 2012)), and "Not classified" in acute toxicity, it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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