GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 32536-52-0
Chemical name Octabromodiphenyl ether
Substance ID 23A5104
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 Not applicable - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable - - - "Solids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Solids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Solids" according to GHS definition.
6 Flammable liquids Not applicable - - - "Solids" according to GHS definition.
7 Flammable solids Not classified - - - Because this substance was judged as an incombustible substance from the information that it is "Not combustible" (ICSC (2008)), use as "a flame retardant" (15911 chemical products (2011)), and the information that "flame retardants and fire preventing agents" (IUCLID (2000)), it was classified as "Not classified."
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 - - - "Solids" according to GHS definition.
10 Pyrophoric solids Not classified - - - Because this substance was judged as an incombustible substance from the information that it is "Not combustible" (ICSC (2008)), use as "a flame retardant" (15911 chemical products (2011)), and the information that "flame retardants and fire preventing agents" (IUCLID (2000)), it was classified as "Not classified."
11 Self-heating substances and mixtures Not classified - - - Because this substance was judged as an incombustible substance from the information that it is "Not combustible" (ICSC (2008)), use as "a flame retardant" (15911 chemical products (2011)), and the information that "flame retardants and fire preventing agents" (IUCLID (2000)), it was classified as "Not classified."
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 Not applicable - - - "Solids" according to GHS definition.
14 Oxidizing solids Not applicable - - - An organic compound contains oxygen and bromine which are not chemically bonded to elements other than carbon.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No established test method suitable for solid substances.

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 - - - All of 4 LD50 values for rats (>28000 mg/kg, >10000 mg/kg, > 5000 mg/kg, >5000 mg/kg) (EU-RAR (2003)) correspond to "Not classified."
1 Acute toxicity (Dermal) Not classified - - - From no death by a dose of 2000 mg/kg in rabbits and an LD50 value of >2000 mg/kg (EU-RAR (2003)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Solids" 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 LD50 value of >15 mg/L/4h (dust) for rats (EU-RAR (2003)), it was classified as "Not classified."
2 Skin corrosion/irritation Not classified - - - Because slight erythema (grade 1) in 3 animals and very slight edema (grade 1) in 2 animals indicated 24 hours after application disappeared after 72 hours (EU-RAR (2003)) as a result of a test applied 500 mg of the test substance to skins of 6 rabbits for 24 hours (GLP compliance), it was classified as "Not classified."
3 Serious eye damage/eye irritation Not classified - - - A slight and transient irritation occurred in a test applied 100 mg to rabbit eyes (GLP compliance), and conjunctival redness of grade 1 only at 1 hour after the application was observed. But no other positive reactions at each observation point up to 7 days were observed. (EU-RAR (2003))
Therefore, it was classified as "Not classified."
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Not classified - - - Because a skin sensitization test using guinea pigs (Magnusson and Kligman test: OECD TG406, GLP) concluded from no sensitizing observation that this substance was not a skin sensitizer (EU-RAR (2003)), it was classified as "Not classified."
5 Germ cell mutagenicity Not classified - - - From a negative result in a micronucleus test using peripheral blood and bone marrow after oral administration to mice (in vivo somatic cell mutagenicity test) (NTP DB (Access on July 2011)), it was classified as "Not classified."
Besides, as in vitro tests, both an Ames test and a chromosome aberration test using mouse peripheral blood lymphocytes reported negatives (EU-RAR (2003)).
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Category 1B

Danger
H360
P308+P313
P201
P202
P281
P405
P501
In a oral administration test in pregnant rats during an organogenetic period, there is the information that embryo absorption at a high ratio and significantly increased incidences of rear limb malformation, slight dilatation of the lateral ventricles of the brain, malformation and incomplete ossification of the scapulae were observed at the high dose (25 mg/kg/day) at which decreased weight gain was observed as general toxicity in maternal animals. (EU-RAR (2003))
From the information that it was classified in Repr. Cat. 2; R61 in EU classification because the possibility that these developmental toxicity effects were not related to maternal toxicity was indicated (EU-RAR (2003)), it was classified in Category 1B.
Besides, in an oral administration test in rabbits during an organogenetic period, no teratogenicity, but a few cases of early deliveries at a dose where maternal animals showed a decreased weight gain was observed. (EU-RAR (2003))
8 Specific target organ toxicity - Single exposure Classification not possible - - - An acute toxicity test by oral administration of 5000 mg/kg to rats (GLP compliance) reported that decreased activity was observed immediately after dosing until 1 hour later, but neither death nor dose-related lesions in final necropsy were observed. (EU-RAR (2003))
Because the findings are observed at a dose much above the upper limit of Guidance values, it is judged to correspond to "Not classified" in an oral route.
On the other hand, an acute toxicity test by inhalation exposure (dust) to rats reported that marked toxic symptoms were not found but decreased motor activity and eye squint at 2 mg/L/1h (0.5 mg/L/4h) and tachypnea at 60 mg/L/1h (15 mg/L/4h) were observed. Another test reported crusta in eye and nose in one animal each at 4.33 mg/L/4h after one day. (EU-RAR (2003))
But because all tests do not have further descriptions, it was classified as "Classification not possible" due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 1 (liver),
Category 2 (lung)

Danger

Warning
H372
H373
P260
P264
P270
P314
P501
Tests using rats found as follows (EU-RAR (2003)):
enlarged liver centrilobular or mid-zonal parenchymal cells accompanied by fine granular structures containing round eosinophilic bodies at the dose of 100 ppm (8.1mg/kg/day, a 90-day equivalent: 2.5 to 2.6 mg/kg/day) or higher in 28-day diet administration;
granular cytoplasmic changes in liver cells at 100 ppm (7.2 to 8.3 mg/kg/day) or higher and cytoplasmic vacuolization showing fatty generation at 1000 ppm (73.7 to 85.6 mg/kg/day) or higher in 90-day diet administration;
focal to multifocal cytoplasmic enlargement in liver cells, focal acidophilic degeneration, and necrosis in the centrilobular regions at 3.7 mg/m3 (a 6-hour-a-day-90-day equivalent 0.767 mg/m3) or higher in a 14-day inhalation exposure (dust);
dose-dependent centrilobular hepatocellular hypertrophy at 16 mg/m2 or higher in a 90-day inhalation exposure.
Because the doses correspond to a range of Category 1 in Guidance values, it was classified in Category 1 (liver).
Furthermore, in a 90-day inhalation exposure (dust) test in rats, alveolar histiocytosis at 202 mg/m3 corresponding to the upper limit of a range of Category 2 in Guidance values, and minimal active chronic inflammation of lung at lower doses were observed. And necropsy reported firmness and enlargement in the bronchial and mediastinal lymph nodes and granulomatous inflammation in these lymph nodes. (EU-RAR (2003)).
Therefore, it was classified in Category 2 (lung).
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) Not classified - - - Because all of the algae, crustacea, and fish did not show effects up to a concentration around the water solubility (1.11E-08 mg/L; PHYSPROP Database, 2009), it was classified as "Not classified."
11 Hazardous to the aquatic environment (Long-term) Category 4
No pictogram

No signal word
H413
P273
P501
Chronic aquatic toxicity for algae and crustacea up to a concentration of the water solubility was not reported.
Though acute toxicity corresponds to "Not classified" in all of 3 trophic levels, from poor water solubility (water solubility, 1.11E-08 mg/L (PHYSPROP Database, 2009)), lack of rapid degradability (OECD 301C:BOD 0% (EU-RAR, 2003)), and log Kow > 4 (8.71 (PHYSPROP Database, 2009)), it was classified in Category 4.
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:
2016/12/19 Addition of Rationale for the classification

List of GHS Classification Results