NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	84-61-7
Chemical Name	Dicyclohexan-1-yl phthalate
Substance ID	m-nite-84-61-7_v2
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 molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Even if it contacts the normal temperature air, it does not ignite spontaneously (ignition temperature 395degC (Merck KGaA data from March 2009)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	The test method applicable for substances becoming liquid or gas at 140degC of test temperature has not been established.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Although it is an organic compound including oxygen, not fluorine and chlorine, this oxygen has not chemically bound to any elements other than carbon and hydrogen.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	The organic compound not including peroxy group in molecule.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	- -	-	-	It was classified into "Not classified" from LD50 value >3,200 mg/kg (NICNAS (2008), CERI/NITE Hazard Assessment Report (2008)), and >40,000 mg/kg (the 3rd volume (2004) of MOE risk assessment) of the oral administration test employing a rat.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Although NICNAS (2008) and CERI/NITE Hazard Assessment Report (2008) has described LD50 value >300 mg/kg of the dermal administration test employing a rabbits, since the category cannot be identified, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	It is written that LC50 value of 1-hour inhalation exposure test employing rats is >3.2 mg/L (CERI/NITE Hazard Assessment Report (2008)). Since 4-hour equivalent LC50 value is >0.8 mg/L when applying the dust standard due to a solid, the classification cannot be specified, and classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	Since there are descriptions, "not irritating" in the skin irritation/corrosion test with rabbits (OECD TG 404) and "slightly irritating" in the study with guinea pig (CERI/NITE Hazard Assessment Report (2008)), it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Not classified	- -	-	-	Since CERI/NITE Hazard Assessment Report (2008) has described as "not irritating" in eye irritation/corrosion test employing rabbits (OECD TG 405), it was classified into "Not classified ".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification is not possible because of insufficient data. In addition, for the impact to humans, the report suggesting asthma was seen in HSDB (2002).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a local lymph node assay with mice (n=7) (LLNA: BrdU-ELISA method) (OECD TG 442B, GLP), the stimulation indices (SI values) in a first experiment were 1.80 (2.5%), 1.91 (5%), and 1.24 (10%). Since the SI value at the high dose level was 1.6 or lower, the study was repeated. The SI values in a second experiment were 2.22 (2.5%), 2.82 (5%), and 1.94 (10%) (ECHA RAC Opinion (2014), CLH Report (2014), REACH registration dossier (Accessed Nov. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Although there is a data that in vitro mutagenicity test (Ames test employing Salmonella typhimurium) is negative in NTP DB (Access on October 2008), classification is not possible because there is no data of in vivo examination.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	Classification is not possible due to insufficiency of data, because evaluation by major international evaluation institutions has not been performed.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a study with female rats which were administered orally from day 0 of gestation until day 21 of rearing, it is reported that "at doses at which lower body weights, increases in liver and adrenal gland weights and centrilobular swelling of hepatocytes were observed in parent animals, prolonged gestation periods and a decrease in the number of births were observed. The following effects on offspring were also observed at the same doses: lower body weight and defects in the kidneys and ureter in males and females; lower kidney, testis, seminal vesicle, epididymis, prostate and anus-bulbocavernosus muscle weights, defects in seminal vesicles, epididymal hypoplasia/agenesis, small testes, loss of germ cells in testes, Leydig cell hyperplasia and loss of sperm in ducts of the epididymis in males; uterine hypoplasia/agenesis, ovarian and oviductal agenesis and mineral deposition at the kidney-corticomedullary junction in females" (CERI/NITE Hazard Assessment Report (2008)). Therefore, because effects were observed in the second generation at doses at which minor effects are observed in parent animals, it was classified as Category 1B. Also, in a two-generation reproductive toxicity study in male and female rats, it is reported that "in F0 and F1 male and female parent animals in the groups with 1,200 ppm or greater, decreased weight gain and feed intake and diffuse hypertrophy of hepatocytes and thyroid follicular epithelial cells were observed, and as effects on offspring, decreases in anogenital distances (AGD) and development of areola mammae were observed in the F1male offspring in the 6,000 ppm group and in the F2 male offspring in the groups with 1,200 ppm or greater" and "a decrease in the number of sperm, but no changes in mating fertility and fertility were observed in the F1 male parent animals" (CERI/NITE Hazard Assessment Report (2008), MOE Risk Assessment, vol. 3 (2004).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	Since MOE Risk Assessment, Volume 3 (2004) has a description of "The eye, skin, and respiratory tract are irritated, it was classified into Category 3 (Respiratory tract irritation).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the two-generation reproduction toxicity study of dietary administration in male and female rats, "diffuse hypertrophy of hepatocytes in liver and follicular epithelial cell hypertrophy of the thyroid were observed in parent animals (F0)" (CERI/NITE Hazard Assessment Report (2008), MOE Risk Assessment vol 3 (2004)), and the primary document (Ministry of Economy, Trade and Industry (2003) Report on two-generation reproduction toxicity study of Dicyclohexyl phthalate) shows that "changes in the liver are considered to be caused by adaptive response induced by drug-metabolizing enzyme. And follicular epithelial cell hypertrophy of the thyroid is considered to be caused by the changes associated with hypertrophy of hepatocytes." Moreover, in the 90-day oral administration test, although it is not within the limits of the guidance value of Category 2, "histological changes in the liver and kidney were observed" (CERI/NITE Hazard Assessment Report (2008), MOE Risk Assessment vol 3 (2004)). Therefore, since some effects of the substance to liver are observed but considered to be caused by adaptive response, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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	- -	-	-	Since 72 hours ErC50 of the algae (Pseudokirchneriella subcapitata) and, 48 hours EC50 of the crustacea (Daphnia magna) and 96 hours LC50 the fish (Oryzias Latipes) were >2.0mg/L (MOE eco-toxicity tests of chemicals (1999)) and acute toxicity within the aqueous solubility concentrations is not reported, it was classified into Not classified.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Although acute toxicity within the water-solubility concentrations is not reported and it was poorly water-soluble (water solubility: 0.2mg/L(20degC) and 4mg/L(24degC) (PHYSPROP Database (2008), MOE Risk Assessment (2008))), since there were rapid degradability (readily degradable, the decomposition by BOD(standard test method (4 weeks)): 68.5% (Existing Chemical Safety Inspections Data (1977))), it was classified into Not classified.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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.

To GHS Information