GHS Classification Result

Chemical Name:diphenyl ether, pentabromo derivative pentabromodiphenyl ether
CAS:32534-81-9

Result:
ID: 20A2271
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 - - - - The substance is documented to be nonflammable (ICSC (J) (2005)), and it is a flame retardant additive (ATSDR (2004)). In addition, there is a description that as a result of combustion tests, it is categorized into incombustible material (Ullmanns (E) (6th, 2003)). Thus, the substance was classified into "Not classified".
7 Flammable solid 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 - - - - The substance is documented to be nonflammable (ICSC (J) (2005)), and it is a flame retardant additive (ATSDR (2004)). In addition, there is a description that as a result of combustion tests, it is categorized into incombustible material (Ullmanns (E) (6th, 2003)). Thus, the substance was classified into "Not classified".
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Not classified - - - - Since it is nonflammable (ICSC (J) (2005)), the substance was classified into "Not classified".
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 contains 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 Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Based on its rat LD50 values: 500-5000 mg/kg bw, 2640 mg/kg bw, 5000 mg/kg bw, 5800 mg/kg bw (female), 6200 mg/kg bw and 7400 mg/kg bw (male) (JECFA (2005)), the substance was classified into "Not classified".
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - In rabbits that were exposed to the substance for 4 hours, one of six treated animals showed erythema of score 1 level, 24 hours after exposure (EU-RAR No. 15 (2002)). Based on this result, the substance was classified into "Not classified".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
In rabbit tests, very slight chemosis and conjunctival redness were observed (EU-RAR No. 15 (2002)). In rat tests, slight evidence of corneal damage was shown (ATSDR (2004)). Based on these outcomes, the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Of two maximization tests conducted using guinea pigs, one test resulted that 3 of 15 treated animals developed very slight erythema 48 hours after administration, and the symptom remained unhealed for 72 hours in one animal (EU-RAR No. 15 (2002)). In the other test, no sensitization occurred in either treated or control groups (EU-RAR No. 15 (2002), In addition, it has been concluded that this substance does not possess significant skin sensitization potential (EU-RAR No. 15 (2002)). Based on these reports, the substance was classified into "Not classified".
5 Germ cell mutagenicity Not classified - - - - Based on negative results in micronucleus tests using peripheral blood of mice (in vivo mutagenicity tests using somatic cells) (NTP DB (accessed in February 2009), the substance was classified into "Not classified". With respect to in vitro mutagenicity tests, one Ames test resulted that mutagenic effects were induced in TA1535 and TA1538 colonies that were not metabolically activated at high concentrations (JECFA (2005)). However, other in vitro tests: different Ames tests and chromosome analyses using human lymphocytes, gave negative results (JECFA (2005), EU-RAR No. 15 (2002), NTP DB (accessed in February 2009)).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Classification not possible - - - - In developmental toxicity tests by means of oral administration (mixed diet) tests using rats or forced oral administration tests, no abnormalities were observed in terms of body weight, male fetal ratio per litter, change in external appearance or teratogenicity (EU-RAR (2002)). However, since no detailed information on sexual functions of parental animals is available, the substance was classified into the "Classification not possible" category. Regarding effects on lactation, it has been documented in human epidemiological surveys that the substance moves through fat tissue into the mother's milk (HSDB (2003)). In neuroethological studies targeting neonatal mice, differences in behavioral patterns were detected between treated and control animal groups in measurements on spontaneous behavior conducted 2 and 4 months after administration, and in Morris swim maze tests conducted 5 months after administration (ATSDR (2004), EU-RAR (2002)).
8 Specific target organ toxicity - Single exposure Classification not possible - - - - In oral administration tests using rats, necrosis of the liver was observed at doses of 2640 mg/kg bw, 5800 mg/kg bw (male), 6200 mg/kg bw and 7400 mg/kg bw (female), which are higher than Category 2 guidance doses (JECFA (2005), EU-RAR No. 15 (2002)). Although an increase in organ weight and activation of enzymes have been recognized to occur at 500 mg/kg bw or lower doses (JECFA (2005), EU-RAR No. 15 (2002)), the effects of the substance within the guidance doses is not clear. Thus, the substance was classified into "Classification not possible".
9 Specific target organ toxicity - Repeated exposure Category 1 (thyroid) Danger H372: Cause damage to organs through prolonged or repeated exposure (thyroid) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In 28-day forced oral administration tests using rats, secretion of total thyroxine and free thyroxine, both constitutes of thyroid hormone drastically dropped at 25 mg/kg/day bw (90-day conversion: 8 mg/kg bw), which falls under Category 1 guidance doses (JECFA (2005)). Of 4-week and 13-week oral administration (mixed diet) tests using rats, both 4-week (conversion value: 1.67 mg/kg) and 13-week (conversion value: 5 mg/kg) administration were associated with reversible, mild hyperplasia of the thyroid gland (EHC (J) No. 162 (1994), JECFA (2005)). Thus, the substance was classified into Category 1 (thyroid gland). Also, 4-week and 90-day oral administration tests (mixed diet and forced oral administration) using rats, an increase in liver weight, enlargement of parenchymal liver cells, the presence of granular structures, and eosinophilic "round bodies" in the cytoplasm were observed at the dose of 5 mg/kg/day; however, these changes were considered too subtle that evaluation was not conducted (JECFA (2005)).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - - Classification is not possible due to lack of appropriate data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - Classification is not possible due to lack of appropriate data.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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