GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 27247-96-7
Chemical name 2-Ethylhexyl nitrate
Substance ID 23A5043
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
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
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Explosives Classification not possible - - - The classification is not possible due to no data although it contains a chemical group associated with an explosive property (nitrate ester).
Besides, it is highly possible to be classified as "Not classified" if it is judged in a prescribed test in UN Recommendations on the Transport because the oxygen balance of -196 is very close to criteria of -200.
2 Flammable gases (including chemically unstable gases) Not applicable - - - "Liquids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Liquids" according to GHS definition.
6 Flammable liquids Category 4
No pictogram

Warning
H227
P370+P378
P403+P235
P210
P280
P501
A flash point of 72 degrees C [closed cup] (IUCLID (2000)), which is > 60 degrees C and <= 93 degrees C, corresponds to Category 4.
7 Flammable solids Not applicable - - - "Liquids" according to GHS definition.
8 Self-reactive substances and mixtures Classification not possible - - - It does not contain a chemical group associated with a self-reactive property but contains a chemical group associated with an explosive property (nitrate ester).
But there are no data.
9 Pyrophoric liquids Not classified - - - It is conceivable that it does not ignite at normal temperatures from an ignition point of 186 to 190 degrees C (IUCLID (2000).
10 Pyrophoric solids Not applicable - - - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Classification not possible - - - An organic compound that does not contain fluorine or chlorine but contains oxygen which is bonded to nitrogen.
But the classification is not possible due to no data.
14 Oxidizing solids Not applicable - - - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No data.

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - From an LD50 value of > 9600 mg/kg bw for rats (USEPA/HPV (2003), corresponding to List 1), it was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified - - - From an LD50 value of > 4800 mg/kg bw for rats (USEPA/HPV (2003)), it was classified as "Not classified" in JIS classification (Category 5 or "Not classified" in UN GHS classification).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Liquids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified - - - From an LC50 value of > 14 mg/L/4h for rats (IUCLID (2000), it was classified as "Not classified."
Besides, it was considered to be a test by mists because the toxicity value (14 mg/L) is above the saturated vapour pressure concentration (2 mg/L).
Furthermore, a state of the substance cannot be specified due to unknown test conditions at the concentration above the saturated vapour pressure concentration (2 mg/L), though an LC50 value of > 4.6 mg/L/1h (>2.3 mg/L/4h) for rats (OECD TG 403; GLP) was reported in a test by "vapour." (IUCLID (2000))
2 Skin corrosion/irritation Not classified - - - On the basis of the "not irritating" evaluation as a result of a test applied to rabbit skins for 4 hours (OECD TG 404, GLP), in which skin reactions were not observed until 24 hours after application and minimal to slight erythema observed at 1 or 2 animals in 48 to 124 hours disappeared after 148 hours (IUCLID (2000)), it was classified as "Not classified."
3 Serious eye damage/eye irritation Category 2B
No pictogram

Warning
H320
P305+P351+P338
P337+P313
P264
From "slightly irritating" evaluation in a test using rabbits (OECD TG 405, GLP) (IUCLID (2000)), it was classified in Category 2B.
Besides, another test dropped 0.1 mL of test substance into rabbit eyes reported "not irritating." (IUCLID (2000)
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Not classified - - - A positive rate of 15% (3/20) or 25% (5/20) including animals with ambiguous reactions which are less than 30% of decision criteria in a maximization test in guinea pigs (OECD TG 406; GLP) (IUCLID (2000)) and no sensitizing reactions (positive rate 0%) in all test animals reported in another maximization test in guinea pigs (IUCLID (2000)), it was classified as "Not classified."
5 Germ cell mutagenicity Classification not possible - - - The classification is not possible due to no in vivo test data.
Besides, as in vitro tests, both an Ames test and a chromosomal aberration test using human peripheral blood lymphocytes reported negatives. (IUCLID (2000)
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Classification not possible - - - In an oral dose reproductive/developmental toxicity screening test (OECD TG 421; GLP) in rats, general toxicity such as salivation and decreased weight gain in parent animals were shown, but neither an effect on copulation ability nor numbers of corpora lutea, implantations, and litter size of pregnant animals differed from a control group were observed. (USEPA/HPV (2006))
Accordingly, it is judged to be no adverse effects on sexual function and fertility of parent animals.
But it was classified as "Classification not possible" due to lack of data on effects on the development of the offspring because there is no data on a fetal examination at the end of gestation.
Besides, the information of a high dose group (500 mg/kg/day) in which one maternal animal had all dead fetus or implantation scars and another animal delivered a litter of small pups all of which died within three days after delivery (USEPA/HPV (2006)) was not used as a basis for the classification, because they are not sufficient bases for fetal toxicity due to only the high dose findings and not clear dose-dependence despite undeniable relationship with administration.
8 Specific target organ toxicity - Single exposure Classification not possible - - - There is the information that three out of ten animals died in oral administration at 9600 mg/kg to rats, but no other signs and lesions in necropsy were observed (USEPA/HPV (2006)), though the classification is not possible due to lack of data.
There is the information that neither deaths nor signs were observed as a result of 1-hour exposure of vapour of 4.6 mg/L to female rats (converted to a 4-hour equivalent value: 2.3 mg/L) in inhalation administration (IUCLID (2000)), but the classification is not possible due to only female results and unknown details.
Besides, there is the information that neither deaths nor signs were observed by the dermal administration to rabbits (USEPA/HPV (2006)), but the classification is not possible due to unknown details.
From the above, it was classified as "Classification not possible" in specific target organ toxicity (single exposure).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - In a 28-day oral repeated dose test in rats, decreases in weight and food consumption, changes in hematology and blood biochemical tests, and urine parameters, increases in liver and kidney weights, and the appearance of hyaline droplets in the proximal tubular epithelium and degeneration of renal tubule of male kidneys as main microscopic changes were observed at 500 mg/kg/day or 100 mg/kg/day or higher. (USEPA/HPV (2006))
Besides, increased liver weights and eosinophilic cytoplasmic inclusions in cells of the renal proximal tubule of kidneys were observed at 14 ppm or higher by a 14-day inhalation exposure to rats. (USEPA/HPV (2006))
These above findings of kidneys in oral and inhalation routes were not used as bases for the classification because they are specific for male rats and are considered to be inapplicable to human.
Therefore it corresponds to "Not classified" in an oral route because the highest dose of 500 mg/kg/day (converted to a 90-day equivalent: 155.5 mg/kg/day) is above the upper limit of Guidance values (100 mg/kg/day).
But the classification is not possible in an inhalation route because the highest concentration of 420 ppm (converted to a 90-day equivalent: 0.468 mg/L) is within a range of Guidance values.
Furthermore, it is reported that no systemic toxic effects were observed at the highest dose of 500 mg/kg/day (converted to a 90-day equivalent: 117 mg/kg/day) above the upper limit of Guidance values (100 mg/kg/day) in a 21-day dermal administration test in rabbits (USEPA/HPV (2006)).
Therefore, it corresponds to "Not classified" in a dermal route.
From the above, it was classified as "Classification not possible" in specific target organ toxicity (repeated exposure) because it corresponds to "Not classified" in the oral and dermal routes and "Classification not possible" in the inhalation route.
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - Due to lack of data, the classification is not possible.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - No data.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* Hazard statement or Precautionary statement will show when hovering the mouse over a code of Hazard statement or Precautionary statement.
   Hazard statement and 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.



Updated date:
  2017/1/30 Addition of Rationale for the classification

List of GHS Classification Results