GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 2082-79-3
Chemical Name n-Octadecyl 3-(4'-hydroxy-3',5'-di-t-butylphenyl) propionate
Substance ID H28-A-030, C-077A
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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
-
-
- -  Solid (GHS definition).
3 Aerosols Not applicable
-
-
- -  Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- -  Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- -  Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- -  Solid (GHS definition).
7 Flammable solids Classification not possible
-
-
- -  No data available.
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 applicable
-
-
- -  Solid (GHS definition).
10 Pyrophoric solids Not classified
-
-
- -  It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 350 deg C (GESTIS (Access on June 2016)).
11 Self-heating substances and mixtures Classification not possible
-
-
- -  Test methods applicable to solid (melting point <= 140 deg C) 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
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Not applicable
-
-
- -  The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- -  Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- -  It is a solid substance with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- -  Based on the LD50 value (OECD TG 401) of > 5,000 mg/kg for rats (SIDS (2006)), the substance was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- -  Based on the LD50 value (OECD TG 402) of > 2,000 mg/kg for rats (SIDS (2006)), the substance was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Classification not possible due to lack of data.
 Besides, although it is reported that LC50 (4 hours) for rats is > 1,811 mg/m3 (converted value: 1.811 mg/L)(SIDS (2006)), it is not possible to identify classification only with this value.
2 Skin corrosion/irritation Not classified
-
-
- -  It is described that in a skin irritation study (OECD TG 404) using rabbits exposed to an undiluted solution of this substance for 24 hours, no irritation was observed (SIDS (2006)). Therefore, this substance was classified as "Not classified" based on the description that this substance is not regarded as a skin irritant (SIDS (2006)).
3 Serious eye damage/eye irritation Not classified
-
-
- -  In an eye irritation study (OECD TG 405) using rabbits, no irritation was observed (SIDS (2006)). Therefore, this substance was classified as "Not classified" based on the description that this substance is not regarded as an eye irritant(SIDS (2006)) .
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  It is reported that in a skin sensitization study (optimization study) using guinea pigs, no sensitization potential was found (SIDS (2006)) but this study was not in accordance with OECD test guidelines. For humans, it is reported that in a skin patch by the challenge after 9-time exposure to this substance in 50 human subjects (Caucasian, 26 males and 24 females, age 22-50 years), no evidence of sensitization was found (SIDS (2006)). However, because there is no negative data other than this report, it was classified as "Classification not possible" due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- -  As for in vivo data, a dominant lethal assay using mice was negative, and both micronucleus assay and chromosome aberration test using Chinese hamster bone marrow cells were negative (SIDS (2006)). As for in vitro data, the bacterial reverse mutation test was negative (SIDS (2006)). From the above, the substance was classified as "Classification not possible" according to the GHS classification guidance for the Japanese Government.
6 Carcinogenicity Classification not possible
-
-
- -  No carcinogenicity data available for humans. As for experimental animals, in a 2-year oral administration study (feeding) using rats or mice no increased incidence of tumours related to treatment was found (SIDS (2006)). However, because there is no classification by other organizations for carcinogenicity, and no carcinogenicity information on other exposure routes (such as inhalation) than oral route is available, the substance was classified as "Classification not possible" due to lack of data.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
 In a two generation study using rats administered (feeding) by the oral route, in the F0 and F1 generation parent animals, reduction in body weight gain and in feed consumption (F0), increased relative liver weights (F0, F1) and centrilobular hepatocyte enlargement (F1) etc. were observed at high doses (5,000 ppm), but no effects on fertility were found (SIDS (2006)). However, in F1 and F2 generation pups, a decrease in live pups per litter at birth (F1) and a decrease in survival index on Day 4 (F1, F2) postpartum were observed at 5,000 ppm, and effects on development of offspring were indicated (SIDS (2006)).
 On the other hand, as a result of gavage administration to pregnant rats or pregnant mice at up to 1,000 mg/kg/day during the organogenesis period, only a decrease in feed consumption in maternal animals and minor developmental effects in the fetus (lower foetal body weight, delayed ossification) were observed in rats (SIDS (2006)).
 From the above, the substance was classified in Category 2 because in a two generation study using rats developmental effects on offspring were observed at doses where general toxicity in parental animals is manifested.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- -  Classification not possible due to lack of data.
 There is no single exposure data of this substance in humans. As for experimental animals, it is reported that in a single-dose study by inhalation using rats, ruffled fur and ventral posture were observed at 0.5 mg/L/4h, which is within Guidance value range of Category 1 (SIDS (2006)). Moreover, it is reported that in a single-dose study by oral administration using rats, diarrhoea, sedation, dyspnoea and hunched posture were observed at 5,000 mg/kg, which is above Guidance value of Category 2 (SIDS (2006)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  No data available for humans.
 As for experimental animals, in an inhalation toxicity study using rats and repeated dose toxicity studies using rats, mice or dogs administered by feeding, hepatocyte hypertrophy and an increase in liver microsomal enzymes etc., considered to be an adaptive response, were observed (SIDS (2006)). However, no effects which become classification basis were observed within the range of up to Category 2. Therefore, the classification is not possible.
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) Not classified
-
-
- -  From 72-hour EbC50 of > 11.3 mg/L for algae (Desmodesmus subspicatus), 24-hour EC50 of > 100 mg/L for crustacea (Daphnia magna), and 96-hour LC50 of > 100 mg/L for fish (Lepomis macrochirus) (all SIDS, 2007), it was classified as "Not classified."
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 not rapidly degradable (a degradation rate by BOD: 21-39 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1997)), 72-hour EbC10 of < 0.5-1 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2007).
 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 the data of acute toxicity either for crustacea or for fish corresponds to "Not classified," it is not rapidly degradable (a degradation rate by BOD: 21-39 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1997)), and it is estimated to be low bioaccumulative (BCF was < 1.2-8.4, < 12- when test concentration was set to be 0.5 mg/L and 0.05 mg/L (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1997)).
 It was classified in Category 2 by drawing a comparison between 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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