NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	117-84-0
Chemical Name	Di-n-octyl phthalate
Substance ID	24B6514
Classification year (FY)	FY2012
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)	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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point of 215 deg C [closed-cup] (NFPA (14th, 2010)) is above 93 deg C.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 390 deg C (NFPA (14th, 2010)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not 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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data 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 LD50 values for rats of 47,000 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)) and 53,700 mg/kg (ASTDR (1997)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 values for guinea pigs of 73,500 mg/kg (NICNAS (2008)) and > 5,000 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (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	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (corresponding to Category 3 in UN GHS classification) because, in skin irritation tests with rabbits and guinea pigs, it was judged as mild irritation or a slight irritant in both animal species (NICNAS (2008)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It was classified in Category 2B because, in eye irritation tests with rabbits and guinea pigs, it was judged as only mild irritation or slight conjunctival irritation in both animal species (NICNAS (2008)).
4	Respiratory sensitization	Classification not possible	- -	-	-	In a survey in children with symptoms of wheezing, rhinitis, or eczema to investigate the relation to phthalate diester contained in the dust in children's bedrooms, there was no association between this substance and allergic symptoms (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)). On the other hand, it is reported that this substance induced asthmatic symptoms in a worker occupationally exposed to the vapour of this substance, and administering an anti-allergic drug inhibited the symptoms (NICNAS (2008)). Because it is described that overall the data available are not sufficiently conclusive to determine the sensitizing activity of this substance (NICNAS (2008)), it was classified as "Classification not possible."
4	Skin sensitization	Classification not possible	- -	-	-	A maximization test with guinea pigs (OECD TG, GLP) gave a negative result (NICNAS (2008)). And in humans, it is reported that in 173 subjects with suspected dermatoses to plastic or glue allergens, none had allergic reactions in a patch test to this substance (PATTY (5th, 2001)). On the other hand, it is reported that 60 out of 400 workers in a plastic shoe factory were patch tested to a standard battery of substances, including phthalates, and six workers with contact dermatitis had positive reactions and those also to this substance (NICNAS (2008)). Because it is described that overall the data available, including the above, are not sufficiently conclusive to determine the sensitizing activity of this substance (NICNAS (2008)), it was classified as "Classification not possible."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, a negative result was reported in an Ames test (NTP DB (1982)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available. Besides, although the details are unknown, it is reported that numerous liver nodules were seen in male rats receiving 15-month diet administration (NICNAS (2008)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a developmental toxicity test with mice orally dosed with 9,780 mg/kg/day on gestational days 6-13, litter size was significantly reduced (NTP-CERHR Monograph (2003), corresponding to List 1), and in a test with rats given intraperitoneal administration of 4890 mg/kg/day or 9,780 mg/kg/day on gestational days 5, 10, and 15, incidences of gross malformations were increased in a dose-related manner (NTP-CERHR Monograph (2003)). Based on the above, and because there are no descriptions of general toxicity in maternal animals, it was classified in Category 2. Besides, in a reproductive toxicity test in which mice were dosed by feeding from one week before mating and over two generations (14 weeks), no adverse effects were reported on mating, fertility, and development of offspring (NTP RACB85047 (1985)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	It was classified in Category 3 (respiratory tract irritation) based on a case report of irritation of the upper respiratory tract in workers exposed to phthalates, including this substance (NICNAS (2008)), and the description that this substance irritates the eye, skin, nose, and throat, causes cough and shortness of breath, and high concentrations may cause irritation or damage to the lung (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 13-week diet administration test with rats, vacuolation, endothelial prominence, anisokaryosis, nuclear hyperchromicity, and vesicle formation were observed in the liver at the highest dose (350-403 mg/kg bw/day) (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)), and in an 11-week diet administration test with rats, liver damage characterized by cellular enlargement and proliferation, vacuolization, chronic inflammation, and necrosis was found at or above 300 mg/kg bw/day (NICNAS (2008)), but all were findings at the doses exceeding the upper limit of the guidance value. It is described that the liver appears to be a primary target organ confirmed in animal tests (ATSDR (1997)), but due to no data near the upper limit of the guidance value range, it was impossible to judge liver effects for classification. Therefore, it was classified as "Classification not possible."
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)	Not classified	- -	-	-	From 96-hour LC50 > 0.045 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)), and 48-hour EC50 > 0.000669 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)), it was suggested that this substance does not cause such aquatic toxicity at its water solubility (0.022 mg/L (PHYSPROP Database, 2009)). Therefore, it was classified as "Not classified."
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, it was classified as "Not classified" because it was suggested that this substance does not cause chronic aquatic toxicity at its water solubility (0.022 mg/L (PHYSPROP Database, 2009)) from 34-day NOEC > 0.045 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)), and 21-day NOEC > 0.00607 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)). Because reliable acute toxicity data were not obtained for a trophic level for which chronic toxicity data are not obtained (for algae), it was impossible to classify the substance by using acute toxicity data. From the above results, it was classified as "Not classified."
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.

To GHS Information