NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	84-74-2
Chemical Name	Di-n-butyl phthalate
Substance ID	25B0015
Classification year (FY)	FY2013
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	FY2007 FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
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 is 157 deg C (closed cup) (HSDB (Access on July 2013)) above 93 deg C.
7	Flammable solid	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 402 deg C (HSDB (Access on July 2013)).
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 in the molecule.
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 by oral administration for rats of 6,300 mg/kg (EU-RAR (2004)) and 8,000 mg/kg (EU-RAR (2004), PATTY (6th, 2012)). Besides, it is described that in a human case of a 23-year-old male worker who accidentally ingested about 10 g, he developed vomiting, dizziness, and a few hours later, lacrimation, pain in the eyes, and severe keratitis. And urinalysis showed microhematuria, oxalate crystals, and leukocytes (EU-RAR (2004)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 by dermal administration for rabbits of >= 4,000 mg/kg (EHC 189 (1997)) and > 20,000 mg/kg (EU-RAR (2004), PATTY (6th, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	It was classified as "Not classified" based on LC50 (mist) of >= 15.68 mg/L for rats (EU-RAR (2004)). Besides, based on the description of an aerosol inhalation test, a reference value in the unit of mg/L as a mist was applied for the classification.
2	Skin corrosion/irritation	Not classified	- -	-	-	It is described in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2003) that skin irritation was observed, but it is described in EU-RAR (2004) (Addendum to the Environmental Section), which is an addendum to EU-RAR (2003), that a test according to OECD TG404 resulted in no irritation, and it is concluded in EU-RAR (2004) that there was no irritation. Therefore, it was classified as "Not classified" (Category 3 in UN GHS classification).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It is described in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2003) that eye irritation was observed and disappeared after 48 or 72 hours, but it is described in EU-RAR (2004) (Addendum to the Environmental Section), which is an addendum to EU-RAR (2003), that a test according to OECD TG405 resulted in no irritation, and it is concluded in EU-RAR (2004) that there was no irritation. Therefore, it was classified as "Not classified" (Category 3 in UN GHS classification).
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	From descriptions in EU-RAR (2004), EHC 189 (1997), dibutyl phthalate did not show skin sensitization in animal tests, but there is a result suggesting that it is positive in case reports in humans. It was classified in occupational skin sensitizers Group 2 in the Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2012), and the Special Committee of the Japanese Society of Occupational and Environmental Allergy (2004) classified it as being sensitizing to the skin. Therefore, it was classified in Category 1.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It 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, a negative result is reported in a micronucleus test with mouse peripheral blood erythrocytes (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EHC 189 (1997), EU-RAR (2004)). And as for in vitro, a positive result was observed in TA100 without metabolic activation in one bacterial reverse mutation test, but all the other reverse mutation tests were negative. Furthermore, it was also negative in a chromosomal aberration test with cultured mammalian cells. Negative and positive results were seen in mouse lymphoma tests with cultured mammalian cells, but it is concluded in EU-RAR (2004), EHC 189 (1997), SIDS (2001), CaPSAR (1994) that this substance is not mutagenic.
6	Carcinogenicity	Classification not possible	- -	-	-	Because it is classified in D in IRIS (1993), it was classified as "Classification not possible" according to the revised GHS classification guidance for the Japanese government.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	From descriptions in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), in oral dose (feeding) reproductive toxicity tests with rats and mice, reduced fertility of F0, atrophy of the testis, decreased sperm production ability, miscarriage in the second trimester of pregnancy, and decreased numbers of pups born (rate) were observed. And in multiple developmental toxicity tests in which pregnant rats and mice were orally administered (gavage or feeding), fetuses and offspring showed malformations (external malformations, skeletal malformations), furthermore in rats, abnormal development of the testis and accessory reproductive glands was found in males of the next generation. Most of the reproductive toxicity in rats and developmental toxicity effects in rats and mice occurred from the doses where general toxicity effects such as reduced weight gain and increased liver weights were not seen in parent animals. Therefore, it was classified in Category 1B according to the GHS classification guidance for the Japanese government.
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) because irritation of the upper respiratory tract, respiratory depression symptoms, etc. were observed at 250 mg/m3 (converted guidance value: 0.125 mg/L/4 hours) in an inhalation exposure (aerosol) test with mice (ACGIH (7th, 2001)). Besides, Category 1 (kidney) was also adopted in the previous classification, but effects on the kidney in humans are limited to a case report on one person. The effects on the nervous system in humans cannot be attributed to this substance (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). As described in the above, it was judged that there were no data on human effects available for classification.
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	It is described that in a 4-week inhalation (aerosol) exposure test with rats, hyperplasia of mucous cells of the nasal cavity and squamoid metaplasia of the larynx were observed as local effects from the low concentration (118 mg/m3: converted guidance value concentration: 0.00036 mg/L/6 hours) within the guidance value range for Category 1 (EU-RAR (2004)). Therefore, it was classified in Category 1 (respiratory system). As for oral administration, in all tests with mice or rats, adverse effects on the liver, blood, testis, etc. were found at higher doses (238 mg/kg/day or above) above the guidance values for Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Therefore, it was classified in Category 1 (respiratory system). Besides, there are no reliable reports on effects in humans. Furthermore, as for Category 2 (liver) in the previous classification, the liver was removed this time because the rationale was not shown in the previous classification, and it was confirmed that the liver was not included in the target organ.
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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.35 mg/L for fish (Perca flavescens) (Initial Risk Assessment (NITE, CERI, NEDO, 2005); CEPA, 1994; EU-RAR, 2003; EHC 189, 1997).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	It was classified in Category 2 due to rapid degradability (a 28-day degradation rate by BOD = 69% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975), BOD5:COD ratio = 0.63 (EU-RAR, 2003)), 10-day NOEC = 0.10 mg/L for crustacea (Gammarus pulex) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), etc.), and 99-day NOEC = 0.10 mg/L for fish (Oncorhynchus mykiss) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), etc.).
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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