GHS Classification Result

Chemical Name:Polybrominated biphenyl (Fire Master BP-6 (Polybrominated biphenyl mixture (Br5-7)) and Fire Master FF-1 (2% calcium polysilicate (anti-caking) added Fire Master BP-6))
CAS:59536-65-1,67774-32-7

Result:
ID: 21A3753
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

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 - - - - Solid (room temperature)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (room temperature)
5 Gases under pressure Not applicable - - - - Solid (room temperature)
6 Flammable liquids Not applicable - - - - Solid (room temperature)
7 Flammable solids Not classified - - - - Classified into Not classified since the substance is an inert solid and has been used as the flame retardant (Sax (11th, 2004)).
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 (room temperature)
10 Pyrophoric solids Not classified - - - - Classified into Not classified since the substance is a flame retardant (Sax (11th, 2004).
11 Self-heating substances and mixtures Not classified - - - - Classified into Not classified since the substance is an inert solid and has been used as the flame retardant (Sax (11th, 2004)).
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 (room temperature)
14 Oxidizing solids Not applicable - - - - Organic compounds containing no oxygen, fluorine or chlorine
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not 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 a LD50 value of 21,500 mg/kg for rats (FireMaster BP-6) (IARC 41 (1986)), the substance was classified into "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Based on a LD50 value of 21500 mg/kg for rats (FireMaster BP-6) (IARC 41 (1986)), the substance was classified as "Not classified".
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (room temperature)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified - - - - Based on no mortality in rats exposed to for the substance (71 mg/L) (FireMaster BP-6) for 1-hour (18 mg/L/4h) (EHC 152 (1994)), the substance was classified as "Not classified". Since the substance was a solid at ambient temperature, the test was considered to be conducted for dusts.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Not classified - - - - Based on negative results in rat spermatogonium and bone marrow chromosomal aberration tests of FireMaster BP-6 (in vivo germ cell or somatic cell mutagenicity test) and mouse bone marrow chromosomal aberration test of FireMaster FF-1 (in vivo somatic cell mutagenicity test) (IARC 41 (1986)), the substance was classified as "Not classified". As relevant information, there is a report of a negative mouse hepatocyte unscheduled DNA synthesis test (EHC 152 (1994)). From in vitro mutagenicity tests, there are reports of a negative Chinese hamster V79 cell gene mutation test (IARC 41 (1986)) and an Ames test (EHC 152 (1994)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Since polybrominated biphenyls are classified into "Group 2B" in IARC (IARC suppl. 7 (1987)), the substance was classified into Category 2. In animal tests, hepatocellular carcinomas or cholangiocarcinomas were observed in male and female rats administered FireMaster FF-1 by gavage for 25 consecutive weeks and maintained for an additional 23 months, and also the incidence of hepatocellular carcinomas was significantly increased in male and female mice (IARC 41 (1986)). Additionally, an increase in the incidences of hepatocellular carcinomas and neoplastic nodules was observed in female rats administered a single dose by gavage of FireMaster FF-1 and observed for additional 23 months. An increase in the incidences of hepatocellular carcinomas and neoplastic nodules was observed in female rats receiving twice-weekly gastric intubations every three weeks for a total of 12 doses and observed for additional 20 months (IARC 41 (1986)).
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
In a test in pregnant rats administered a single oral dose of 40 - 800 mg/kg of FireMaster BP-6 on one of days 6 - 14 of gestation, all treated females lost weight and malformed fetuses (mainly, diaphragmatic hernia and cleft palate) were seen at a dose level of 800 mg/kg, regardless of the day of exposure (IARC 41 (1986)). In mice treated with FireMaster BP-6 during organogenesis at up to 130 mg/kg/day, an increase in exencephaly, cleft palate and hydronephrosis was reported (PATTY (5th, 2001)). Based on all information, the substance was classified into Category 2. As relevant information, effects considered as neurodevelopmental disorder were reported in offspring of rats that received the substance from day 6 of gestation through day 24 postpartum (ATSDR (2004)).
8 Specific target organ toxicity - Single exposure Category 2 (liver) Warning H371: May cause damage to organs (liver) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
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.
P405: Store locked up.
P501: Dispose of contents/container to ...
It was reported that rats developed enlarged livers with fatty and necrotic changes leading to fibrosis and nodulation following administration of FireMaster FF-1 as a single dose of 1000 mg/kg and observed for 2 ? 23 months post-treatment (ATSDR (2004), EHC 152 (1994)). Since the results were observed at a dose level within the guidance value range for Category 2, the substance was classified into Category 1 (liver).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, nervous system) Danger H372: Cause damage to organs through prolonged or repeated exposure (liver, nervous system) 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 oral tests with FireMaster FF-1, incidences of hepatocellular hypertrophy, cytoplasmic vacuolation, atypical foci and oval cell hyperplasia were increased in rats fed >=0.5 mg/kg/day for up to 104 weeks, and hepatocyte necrosis and/or vacuolation were induced in mice receiving >=3 mg/kg/day for 4 - 6 weeks. In rat and mouse 6-month oral tests (3 days/week), decreased motor activity, grip strength and startle responsiveness were observed at dose levels of 3 - 10 mg/kg/day (ATSDR (2004)). Since the reported results were observed at dose level within the guidance value range for Category 1, the substance was classified into Category 1 (liver, nervous system).
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 - - - - No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.


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

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