GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 117-84-0
Chemical Name Di-n-octyl phthalate
Substance ID H28-B-050, C-084B
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 FY2012   FY2006  
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) 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
-
-
- -  From the flash point data of 215 deg C (open-cup) (HSDB (Access on August 2016)), it is estimated that it corresponds to "Not classified" also in the prescribed test method.
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 (HSDB (Access on August 2016)).
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
-
-
- -  There are 3 reported LD50 values for rats of 47,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)), 53,700 mg/kg (ATSDR (1997), NICNAS (2015), PATTY (6th, 2012)), and 47,000-53,700 mg/kg (Evaluation of effect for the food safety (Food Safety Commission, 2016)). Based on these, it was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- -  From the LD50 value of 73,350 mg/kg which was converted using specific gravity of 0.978 and the LD50 value of 75 mL/kg (NICNAS (2015), Evaluation of effect for the food safety (Food Safety Commission, 2016), PATTY (6th, 2012)) for guinea pigs, 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) Classification not possible
-
-
- -  Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- -  In skin irritation tests using rabbits and guinea pigs, irritation was slight (ATSDR (1997), NICNAS (2015)). In addition, because irritation was not observed in a human patch test (NICNAS (2015)), it was classified as "Not classified" (Category 3 in UN GHS classification).
3 Serious eye damage/eye irritation Not classified
-
-
- -  In a test using guinea pigs, slight conjunctival irritation was observed, but no effects on the cornea were observed (ATSDR (1997), NICNAS (2015)). Also, it is reported that in tests using rabbits, clear results were not obtained (NICNAS (2015)) or it was negative (PATTY (6th, 2012)). As for humans, it is reported that eye irritation was observed in workers exposed to phthalates including this substance, however, NICNAS evaluated that it was the effect shown by limited data. Based on the above information, it was classified as "Not classified." Since new information was added to the information used for the previous classification and it was reexamined, classification was changed.
4 Respiratory sensitization Classification not possible
-
-
- -  In a study on 102 children of 2-7 years of age who had symptoms of wheezing, rhinitis, and eczema (control group: 82), which examined the relationship with the phthalic diester contained in a dust in the children's bedroom, no association was found between allergic symptoms and this substance (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)). On the other hand, a case is reported who developed asthma by occupational inhalation of dioctyl phthalate vapor (NICNAS (2015)). It was described that overall, data are not sufficient to determine the sensitizing activity of this substance (NICNAS (2015)). Therefore, it was classified as "Classification not possible."
4 Skin sensitization Classification not possible
-
-
- -  In a skin sensitization test using guinea pigs, it was negative though details such as test methods were unknown (ATSDR (1997), NICNAS (2015)). On the other hand, in a patch test conducted on workers who developed contact dermatitis, 6 out of 30 workers showed a positive reaction to dioctyl phthalate (NICNAS (2015)). It was described that overall, data are not sufficient to determine the sensitizing activity of this substance (NICNAS (2015)). Therefore, it was classified as "Classification not possible."
5 Germ cell mutagenicity Classification not possible
-
-
- -  Classification not possible due to lack of data. There is no in vivo data. As for in vitro, bacterial reverse mutation tests were negative (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), ATSDR (1997), CEPA (1993), NICNAS (2015), NTP DB (Access on July 2016)).
6 Carcinogenicity Classification not possible
-
-
- -  Classification not possible due to lack of data. Besides, after an intraperitoneal administration of diethylnitrosamine (DEN) following partial hepatectomy of male rats, administration of this substance by feeding for 60 to 65 weeks (5,000, 10,000 ppm) resulted in an increase in the incidence of liver carcinoma in a dose-dependent manner, and an increase in the incidence of liver tumors (adenoma, carcinoma) was also observed at 10,000 ppm in DEN non-exposure groups (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
 In a study using mice dosed by gavage at 9,780 mg/kg/day on gestational days of 6 to 13, reduction in the number of pups born and body weight gain was observed (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), ATSDR (1997), NICNAS (2015)). In addition, in a test using rats intraperitoneally dosed at 4,890 or 9,780 mg/kg/day on gestational days of 5, 10 and 15, low fetal body weight and an increase in the incidence of external malformations (tail absence, absence of eyes, hind legs abnormality (twist), etc.) were observed (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), NICNAS (2015)). Based on the above, it was classified in Category 2 for this hazard class. Besides, in a continuous breeding study using mice, no effects on the breeding results of F0 and F1 generations were observed (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), ATSDR (1997), NICNAS (2015)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- -  Classification not possible due to lack of data. In humans it is described that this substance may irritate the eyes, skin, nose and throat, may cause cough and shortness of breath, and may cause irritation or injury of the lungs at high concentrations (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)), however, the original information source was HSFS which is listed in List 3, and original article could not be confirmed. Also, there is one case report that the upper respiratory tract irritation was observed in workers (plural) exposed to phthalates including dioctyl phthalate (its isomer was not specified), however, it is concluded that the data are insufficient to determine it as a respiratory irritant (NICNAS (2015)). From the above, it was classified as "Classification not possible." Besides, in the previous classification, it was classified in Category 3 (respiratory irritation) based on the information above, but as a result of re-examination of the information, the classification was changed.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  As for humans, there is a report of polyneuritis due to the exposure to phthalate including this substance (NICNAS (2015)), but there was no information that can identify the effect of this substance.
 In a 21-day repeated dose toxicity test using rats dosed by diet, centrilobular hepatocellular necrosis/lipid droplet, liver glycogen depletion, peroxisome proliferation of the liver, etc. were observed at 2% (converted guidance value: 233.3 mg/kg/day) which is outside of the range of Category 2 (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), NICNAS (2015)). In a 13-week repeated dose toxicity test using rats dosed by diet, liver vacuolation, thyroid follicle size reduction, mild colloid density reduction, etc. were observed at 0.5% (350 to 403 mg/kg/day) (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), Evaluation of effect for the food safety (Food Safety Commission) (2016)). In a 12-month repeated dose toxicity study using rats dosed by diet, increase in liver weight, and increase in AST and ALT were observed at 0.35% (175 mg/kg/day) which is outside the range of Category 2 (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)).
 As above, mainly effects on the liver were observed, however, since all of them were observed at doses exceeding Category 2, it was classified as "Classification not possible."
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data. Besides, from the numerical data (viscosity: 39 mPa*s (20 degC), density (specific gravity): 0.978 (20 degC)) listed in HSDB (Access on July 2016), kinematic viscosity is calculated as 39.9 mm2/sec 20/20 degC).

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 48-hour EC50 of > 0.000669 mg/L for crustacea (Daphnia magna) and 96-hour LC50 of > 0.045 mg/L for fish (Pimephales promelas) (both Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)), 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 rapidly degradable (a degradation rate by BOD: 67% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 21-day NOEC > 0.000607 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, 2005), Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)).
 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" because it is rapidly degradable (a degradation rate by BOD: 67% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and it acute toxicity data on fish corresponds to "Not classified."
 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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