NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	3648-21-3
Chemical Name	Di-n-heptyl phthalate
Substance ID	24B6517
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	- -	-	-	Both flash points of 113 deg C [closed-cup] (MSDS (Sigma-Aldrich, 2012), GESTIS (Access on Apr. 2012)) and 224 deg C [closed-cup] (ICSC (J) (2003)) are 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	Classification not possible	- -	-	-	No data available.
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" because the administration of 2,000 mg/kg to rats caused no death, and an LD50 value was > 2,000 mg/kg (JECDB (Access on Apr. 2012)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
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	Classification not possible	- -	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
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, there is a report on negative results in both an Ames test and a chromosomal aberration test with Chinese hamster CHL cells (JECDB (Access on Apr. 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a reproductive toxicity screening test in which male and female rats were orally dosed from 14 days before mating through mating for 42 days for males, and through gestation and parturition by day 3 of lactation for females, seven females died on gestational days 20-22 in the 1,000 mg/kg group, and decreased delivery index due to death was observed, but there were no changes in the other indexes of sexual function and fertility, also in offspring, no treatment-related effects were seen in developmental parameters, or in external examination (JECDB (2007)). On the other hand, in a test with mice given a single oral dose during a gestation period, increased embryonic/fetal mortality was found in all groups but the control group, and embryos in the group dosed with 7.5 mL/kg on day 8 had 100% resorptions. And increased external malformations were observed in fetuses in the groups dosed on day 8 or 9, which had many encephaloceles, eyelid opening, cleft palate, and missing toes. The groups dosed on day 10 or 11 had many abnormal tails, missing toes, and hematoma, their skeletal malformations/variations were seen in the skulls, vertebrae, ribs, and limb bones, and all fetuses in the group dosed with 2.5 mL/kg on day 8 had fused ribs (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)). From the above, no reproductive toxicity was observed in the one-generation reproductive test with rats, but in the developmental toxicity test with mice given a single oral dose during a gestation period, there are no descriptions of general toxicity in parent animals, and there is a report on increased embryonic/fetal mortality, 100% embryonic resorptions, increased external malformations, and increased skeletal malformations/variations. Therefore, it was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In a single oral administration test with rats (OECD TG401, GLP) (doses 500, 1,000, 2,000 mg/kg bw), there was no death at any dose, and no effects of administering this substance were observed in general status observation, body weight changes, necropsy, or histopathological examination (JECDB (Access on Apr. 2012)). From the results, it corresponds to "Not classified" in the oral route, however, because effects of exposure in the other routes are unknown due to no data, it was classified as "Classification not possible" for specific target organ toxicity (single exposure).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 28-day repeated oral administration test with rats, as liver effects, prolongation of prothrombin time and activated partial thromboplastin time in males at or above 250 mg/kg, and histopathological lesions of centrilobular hypertrophy of hepatocytes, centrilobular fatty change of hepatocytes, and single-cell necrosis of hepatocytes in the centrilobular zone in males at 1,000 mg/kg, related to decreased serum beta-globulin fraction in the 1,000 mg/kg group, were observed. As kidney effects, an increase in urine protein positive cases in females at 1,000 mg/kg and increased blood urea nitrogen in males at 1,000 mg/kg were found, but no histopathological changes were seen. As effects on male genetic organs, histopathological examination revealed a loss of spermatogenic cells in the testis, and a decrease in sperms in the duct and the appearance of detached spermatogenic cells in the epididymis in the 1,000 mg/kg group (JECDB (Access on Apr. 2012)). From the above results, a change at 250 mg/kg/day (converted guidance value: 77.8 mg/kg/day) was limited to prolongation of prothrombin time and activated partial thromboplastin time in males, and other effects on the liver, kidney, and male genetic organs were findings all at 1,000 mg/kg/day (converted guidance value: 311 mg/kg/day), which exceeds the guidance values. Because effects near the upper limit of the guidance value range are unknown, it was classified as "Classification not possible." Besides, also in another 28-day repeated dose oral administration test with rats, liver effects such as increased GOT, GPT, and ALP, and hepatocellular hypertrophy and necrosis were observed, and a loss of spermatogenic cells and seminiferous tubular atrophy are reported as testicular effects (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)), but all were findings at high doses of 1,000 mg/kg/day (converted guidance value: 311 mg/kg/day) or above.
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)	Classification not possible	- -	-	-	Because reliable data were not obtained at concentrations up to the water solubility, the classification is not possible.
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 due to being rapidly degradable (a degradation rate by BOD of phthalic acid, the hydrolysate: 85.2% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and 21-day NOEC = 0.040 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, 1995)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, it is impossible to determine the classification because reliable acute toxicity data were not obtained for fish and algae. By drawing a comparison between the above results, it was classified in Category 2.
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