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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	68515-49-1,26761-40-0
Chemical Name	Diisodecyl phthalate [DIDP]
Substance ID	H28-B-048, C-083B
Classification year (FY)	FY2016
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	FY2010
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)
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	- -	-	-	From a flash point of 229 deg C (closed cup) (ICSC(J) (1998)), it corresponds to "Not classified."
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 402 deg C (ICSC(J) (1998)).
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	- -	-	-	Not containing 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	- -	-	-	There are five reports of LD50 values for rats of > 6,000 mg/kg (PATTY (6th, 2012), HSDB (Access on July 2016)), > 15,000 mg/kg (EU-RAR (2003), DFGOT (2015)), > 29,100 mg/kg (EU-RAR (2003), NICNAS (2015), DFGOT (2015), Evaluation of effects on food safety (Food Safety Commission, 2016)), > 62,080 mg/kg (EU-RAR (2003), NICNAS (2015), Evaluation of effects on food safety (Food Safety Commission, 2016)), 64,000 mg/kg (HSDB (Access on July 2016)). Based on these, it was classified as "Not classified."
1	Acute toxicity (Dermal)	Not classified	- -	-	-	There are reports of an LD50 value of > 2,910 mg/kg (EU-RAR (2003), NICNAS (2015), DFGOT (2015)) for rats, which corresponds to "Not classified." There are two reports of LD50 values of > 3,160 mg/kg (EU-RAR (2003), NICNAS (2015), DFGOT (2015)), and > 9,700 mg/kg (EU-RAR (2003), HSDB (Access on July 2016)) for rabbits, both of which correspond to "Not classified." Based on these, it was classified as "Not classified."
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	- -	-	-	Based on a report of an LC50 value (4 hours) of > 12.54 mg/L (females and males) (EU-RAR (2003), NICNAS (2015), DFGOT (2015), Evaluation of effects on food safety (Food Safety Commission, 2016), HSDB (Access on July 2016)) for rats, it was classified as "Not classified." Besides, since this value is higher than the saturated vapor pressure concentration (12.7 ng/L), a reference value of mist was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	In a skin irritation test (OECD TG 404) using rabbits, transient very slight irritation was observed. Moreover, in other rabbit skin irritation tests (4-hour application), skin irritation was transient and very slight (EU-RAR (2003), DFGOT (2015)). Also, in a human patch test, when applying 0.2 mL occlusively for 24 hours to 15 subjects, irritation was not observed in the examinations at 30 minutes and 24 hours after patch removal (EU-RAR (2003)). Based on these results, it was judged to be classified as "Not classified" (Category 3 in UN GHS classification).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In an eye irritation test (OECD TG 405) using rabbits, conjunctival redness (score 2) was observed at 1 hour after application but was not observed after 24 hours (DFGOT (2015), EU-RAR (2003)). Also, in other eye irritation tests using rabbits, very slight conjunctival redness and swelling were observed transiently but disappeared within 48 hours and no effect on the cornea and iris was observed (DFGOT (2015), EU-RAR (2003), PATTY (6th, 2012)). Based on these results, eye irritation was judged to be extremely weak, and it was classified as "Not classified."
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	In a skin sensitization test (modified Buehler test) using guinea pigs, erythema was observed in 15 out of 20 animals and edema was found in one animal, and it was judged as positive (DFGOT (2015), EU - RAR (2003)). On the other hand, in other skin sensitization tests (Buehler test and maximization test), both were negative (DFGOT (2015), EU-RAR (2003), PATTY (6th, 2012)). In addition, in humans, in patch tests on 104 volunteers, 310 patients with dermatosis, 144 patients with plastic or glue allergy, no positive reaction was observed in any cases (DFGOT (2015), EU-RAR (2003), PATTY (6th, 2012)). Because conflicting data were obtained, it was classified as "Classification not possible."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance 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 micronucleus assay using mouse bone marrow cells is negative (EU-RAR (2003), NICNAS (2015), PATTY (6th, 2012)). As for in vitro, bacterial reverse mutation tests, and mouse lymphoma assays using cultured mammalian cells are negative (EU-RAR (2003), NICNAS (2015), PATTY (6th, 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, an increased incidence of mononuclear cell leukaemia (MNCL) was observed in a carcinogenicity study using rats given this substance by feedings for 2 years. However, MNCL is a common neoplasm in F344 rats, and it was judged as not relevant to humans. In addition, no increased incidence of tumor related to the administration was observed (NICNAS (2015), PATTY (6th, 2012)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In two 2-generation reproductive toxicity studies using rats administered by the oral route (feeding), no effect on fertility was observed even at the doses where general toxic effects (reduction in body weight gain, increase in liver and kidney weight, etc.) were observed in F0 and F1 parental animals. However, in the F1 and F2 pups, there was an increase in the mortality rate up to postnatal day four (up to weaning at high doses), and in one test, in addition, delay in preputial separation was observed in F2 (NICNAS (2015), PATTY 6th, 2012)). On the other hand, as a result of gavage administration to pregnant rats during the organogenesis period, slight effects (skeletal variation such as supernumerary ribs etc.) were only observed in the fetus at the doses lower than the doses with general toxicity in maternal animals (NICNAS (2015) , PATTY (6th, 2012)). As above, the substance was classified in Category 2 for this hazard class since the postnatal mortality rate of the pups was increased at the dose where general toxicity in parental animals is manifested in two-generation studies using rats.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	There is no single exposure data on this substance in humans. As for experimental animals, in rats given this substance by oral administration at a dose exceeding the guidance value ranges of Category 2, there was no mortality or manifestation of symptoms, and no change in necropsy was observed (EU-RAR (2003)). Also, when rabbits were dermally administered at doses exceeding the guidance value range of Category 2, general symptoms such as anorexia etc., and dark reddening of the lungs at the necropsy were observed when applied on abraded skin, but when applied on healthy skin, only skin erythema as a local effect was observed, and systemic toxicity was not observed (EU-RAR (2003)). Also, in dermal administration at a dose exceeding the guidance value range of Category 2 to rats, no general symptoms and pathological abnormalities at necropsy were observed (EU-RAR (2003)). Furthermore, in an acute study using rats exposed by inhalation at doses exceeding the guidance value range of Category 2, it is only reported that symptoms after the exposure were agitation and unkempt appearance, and as the sole pathological finding at necropsy, numerous dark red foci in the lung were more frequently observed in the treated group (EU-RAR (2003)). From the above, since effects of this substance in animals studies were observed only when large amounts of this substance exceeding the guidance value range were administered, it is not possible to estimate the effects in humans. Therefore, because there is not sufficient data available for the judgement of category, it was classified as "Classification not possible" according to the GHS classification guidance for the Japanese government.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is no information on humans. As for experimental animals, in a 13-week repeated dose toxicity study using dogs administered by feeding, hypertrophy and vacuolation of hepatocytes were observed at 75 mg/kg/day, which is within the range of Category 2 (EU-RAR (2003), NICNAS (2015), DFGOT (2015), Evaluation of effects on food safety (Food Safety Commission, 2016)). In several 21-day to 2-year repeated dose toxicity studies using rats administered by feeding, hypertrophy of hepatocytes and induction of drug-metabolizing enzymes, etc. in the liver have been reported at outside the range of Category 2 (EU-RAR (2003), NICNAS (2015), DFGOT (2015), Evaluation of effects on food safety (Food Safety Commission, 2016)). The changes in the liver seen in dogs are not regarded as serious toxicological findings since histological changes are slight, dose dependency is absent, and effects in liver enzymes such as ALT and AST are not observed, etc. (EU-RAR (2003)). As mentioned above, the effects on the liver was observed in the oral route, however, they are not serious changes and data on other routes are insufficient. Therefore, it was not classified as "Not classified" but "Classification not possible."
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, from numerical data (viscosity: 130 mPa*s (20 deg C), density (specific gravity): 0.97 (20 deg C)) listed in EU-RAR (2003), the kinematic viscosity is calculated to be 134 mm2/sec (20/20 deg C).

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 72-hour EC50 >= 500 mg/L for algae (Desmodesmus subspicatus), 48-hour EC50 >= 0.18 mg/L for crustacea (Daphnia magna), and 96-hour LC50 >= 0.55 mg/L for fish (Lepomis macrochirus) (all EU-RAR, 2003), it was classified as "Not classified."
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 2% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)), and 21-day NOEC >= 0.1 mg/L for crustacea (Daphnia magna) (EU-RAR, 2003). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 2% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)), and 96-hour LC50 >= 0.55 mg/L for fish (Lepomis macrochirus) (EU-RAR, 2003). It was classified as "Not classified"from the above results.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

NOTE:

* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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