Environmental Profiles of Chemical Flame-Retardant Alternatives for

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Type: Bacterial reverse mutation Species, strain: Salmonella typhimurium TA97, TA98, TA100, TA1535, TA1537 Metabolic activation: Tested with and without S9 from livers of Aroclor-induced male Sprague-Dawley rats or male Hamsters Concentrations: 0, five concentrations between 10 and 10,000 :g/plate. Purity: 94.4% Method: Preincubation (20 minutes) and plate incorporation (48 hours) at 37°C. Positive controls were used; DMSO was the solvent. Triplicate plates per concentration. All assays repeated within 1 week. Results: In three different laboratories, Proprietary A tested positive in strains TA97 and TA100 in the presence of S9 from Aroclor-induced hamster liver and in strain TA1535 in the presence of S9 from Aroclor-induced rat or hamster liver. Positive controls gave expected increases. Solvent control and all other test combinations were negative. Reference: Ref. 37 Type: Bacterial reverse mutation Species, strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 Metabolic activation: Tested with and without Kanechlor 500 (PCB)-induced liver S9 from male Wistar rats Concentrations: 0, 10, 30, 100, and 300 :g/plate. Purity: Assayed as ~94% Proprietary A, plus ~6% [Chemical 7] Method: Plate incorporation, 48-hour incubation at 37°C. Cited Ames protocol, which presumes the use of replicates and positive controls. Results: No increase in revertants in any strain without activation or in strains TA98, TA1537, or TA1538 with activation. Weak increases in TA100 and TA1535 at the highest concentrations with S9. Reference: Ref. 38 Additional Studies Other S. typhimurium assays in which S9 was prepared from phenobarbital-induced rat liver reported mutagenicity of Proprietary A in strain TA98 by liquid preincubation assay (Ref. 1) and in TA100 by plate incorporation assay (Ref. 25, 48). Ref. 36 reported dose-related positive results for Proprietary A and its metabolite [Chemical 8] in TA100 with S9 (phenobarbitalinduced) in standard plate assays at concentrations up to 500 :g/plate. In a liquid preincubation quantitative assay, results for Proprietary A were essentially negative—only increasing mutation frequencies at cytotoxic concentrations (survival
C In vitro Mammalian Cell Gene Mutation Test (OPPTS Harmonized Guideline 870.5300; OECD Guideline 476) Type: Mammalian Cell Gene Mutation Test: Forward Mutation Species, strain: Mouse lymphoma L5178Y Metabolic activation: Tested with and without phenobarbital-induced liver S9 from male mice Concentrations: 0, and five concentrations up to ~32 nL/mL without S9, and six concentrations up to 70 nL/mL with S9. Test conditions chosen based on preliminary assays so that 50% growth reduction occurred at highest concentration. Purity: Not reported Method: Selection of forward mutation from TK+/- to TK-/- genotype. Activity compared to [Chemical 2]. Results: Proprietary A yielded negative results with or without activation. [Chemical 2] was negative without, but positive with activation. Reference: Ref. 12; also Ref. 33 Type: Mammalian Cell Gene Mutation Test: Forward Mutation Species, strain: V79 Chinese hamster lung cells Metabolic activation: Tested with phenobarbital-induced liver S9 from male rats Concentrations: 0, 0.02 mM Proprietary A. Test conditions chosen based on preliminary assays. Purity: Not reported Method: In two experiments, selection of 6-thioguanine-resistant colonies. Activity compared to [Chemical 2]. Results: Proprietary A with S9 did not increase mutation frequency. [Chemical 2] yielded positive results. Reference: Ref. 48 Gene Mutation in Vivo: C Sex-linked Recessive Lethal test in Drosophila melanogaster (OPPTS Harmonized Guideline 870.5275) Type: Sex-linked Recessive Lethal test Species, strain: Drosophila melanogaster, 100 males/concentration Metabolic activation: None Concentrations: 2.5 and 25% in feed (1% gum tragacanth in 3% sucrose) Purity: Technical-grade [Formulation 2], purity not reported Method: Proprietary A added to feed of males for 24 hours, subsequently mated with virgin unexposed females Results: No evidence of toxicity or increase in the percentage of sex-linked recessive lethal mutations. Reference: Ref. 11 as described in Ref. 61; also Ref. 32 4-24
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Volume 2 Chemical Hazard Reviews Fu
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LIST OF TABLES Page 1-1 Summary of
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Flame Retardant Alternatives Triphe
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Triphenyl Phosphate: Existing Data
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Type: Acute oral LD50 Species, stra
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concentration was much higher, but
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Vehicle: Not reported, but acute or
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• 90-Day Oral Toxicity in Rodents
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Subchronic Inhalation Toxicity: 90-
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hydroureter, enlarged ureter proxim
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NEUROTOXICITY Conclusion: The avail
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Critical Studies Type: Delayed neur
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Neurotoxicity (Adult) Conclusion: T
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Species, strain, sex, number: Rat,
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Type: Mitotic Gene Conversion Speci
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Study Reference Ahrens et al., 1978
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Study Reference Geiger et al., 1986
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Study Reference Mayer et al., 1981
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Study Reference Sasaki et al., 1981
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those reported in the publicly avai
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Algal Toxicity (OPPTS Harmonized Gu
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Study Reference Millington et al.,
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Chronic Toxicity to Fish (OPPT Harm
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Chronic Toxicity to Aquatic Inverte
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Log K ow Reference 4.63 Saeger, 197
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Oxidation/Reduction: No data Oxidat
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Bioconcentration Environmental Fate
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Fish Metabolism: Conclusion: The me
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Study Type/ Method Innoculum Acclim
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Sediment/Water Biodegradation: Conc
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References Ahrens, V; Henion, J; Ma
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Dorby, A; Keller, R. 1957. Vapor pr
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Johnson, MK. 1975. Organophosphorus
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Perry, R; Green, D. 1984. Vapor pre
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Flame Retardant Alternatives Tribro
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Tribromoneopentyl alcohol: Existing
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Results: Male mortality was 2/5 at
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Additional Study: An acute inhalati
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application, four rabbits displayed
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Bladder effects were seen in some o
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• Combined Repeated Dose Toxicity
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• Immunotoxicity (OPPTS Harmonize
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tissue, one with rabbit tissue) sug
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Acute Toxicity to Aquatic Organisms
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1-Propanol, 2,2-dimethyl-, tribromo
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Environmental Fate Bioconcentration
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References AmeriBrom, Inc. 1982a. A
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Flame Retardant Alternatives Tris(1
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Tris(1,3-dichloro-2-propyl) phospha
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Species, strain, sex, number: Rat,
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Results: No mortality after 14 days
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Additional Studies: Another study,
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occurred in treated groups compared
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high enough to induce significant r
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Doses: 0, 25, 100, and 400 mg/kg/da
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mid-dose of 20 mg/kg/day as a LOAEL
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Critical Studies Type: Acute oral d
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English summary and therefore could
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Basis for Conclusion: TDCPP has bee
Page 123 and 124: Gene Mutation in Vivo: C Sex-linked
Page 125 and 126: TDCPP administered as 2,000 mg/kg b
Page 127 and 128: Another study showed that the 96-ho
Page 129 and 130: Study Reference Akzo- Nobel, Inc.,
Page 131 and 132: Study Reference Sasaki et al., 1981
Page 133 and 134: Table 3-2. Summary of available acu
Page 135 and 136: hours (Unpublished study conducted
Page 137 and 138: Terrestrial Organism Toxicity Acute
Page 139 and 140: Oxidation/Reduction: No data Meltin
Page 141 and 142: pH: This chemical does not contain
Page 143 and 144: Species Rate Comment Reference Kill
Page 145 and 146: Pyrolysis Products Reference When h
Page 147 and 148: Brusick, D; Matheson, D; Jagannath,
Page 149 and 150: Majeska, JB; Matheson, DW. 1983. Qu
Page 151 and 152: Thomas, MB; Collier, TA. 1985. Tolg
Page 153 and 154: Proprietary A: Chloroalkyl phosphat
Page 155 and 156: Proprietary A: Chloroalkyl phosphat
Page 157 and 158: Basis for Conclusion: The available
Page 159 and 160: Additional Studies and Information:
Page 161 and 162: Conclusion: The available subchroni
Page 163 and 164: Basis for Conclusion: No repeated-e
Page 165 and 166: Prenatal Developmental Toxicity Stu
Page 167 and 168: Combined Chronic Toxicity/Carcinoge
Page 169 and 170: Basis for Conclusion: The delayed n
Page 171 and 172: histopathological effects in the ne
Page 173: Immunotoxicity (OPPTS Harmonized Gu
Page 177 and 178: Chromosomal Aberration in Vivo: C M
Page 179 and 180: Aquatic Organism Toxicity Ecotoxici
Page 181 and 182: Study Reference Species Tested Ref.
Page 185 and 186: Acute Toxicity to Freshwater Invert
Page 187 and 188: Chronic Toxicity to Freshwater and
Page 191 and 192: CAS MF MW SMILES Physical/Chemical
Page 193 and 194: Vapor Pressure (torr//C) Reference
Page 195 and 196: Bioconcentration Environmental Fate
Page 197 and 198: Study type/ Method Innoculum Acclim
Page 199 and 200: Flame Retardant Alternatives Propri
Page 201 and 202: Proprietary B: Aryl phosphate Exist
Page 203 and 204: ACUTE TOXICITY Human Health Endpoin
Page 205 and 206: Additional Studies and Information:
Page 207 and 208: were elevated in all treated groups
Page 209 and 210: Basis for Conclusion: No pertinent
Page 211 and 212: Experiment B. Doses were chosen bas
Page 213 and 214: These studies may be indicated, for
Page 215 and 216: • Mammalian Bone Marrow Chromosom
Page 217 and 218: • Algal Toxicity (OPPTS Harmonize
Page 219 and 220: Bioconcentration Fish: No data Daph
Page 221 and 222: Flame Retardant Alternatives Propri
Page 223 and 224: Proprietary C: Chloroalkyl phosphat
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Basis for Conclusion: Acute oral to
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Acute Eye Irritation (OPPTS Harmoni
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Critical Studies: Type: Dermal sens
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C Reproduction/Developmental Toxici
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• Combined Chronic Toxicity/Carci
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Gene Mutation in Vitro: • Bacteri
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• Acute Oral Toxicity in Birds (O
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Corrosion Characteristics: No data
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determined at 50°C and it was foun
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Proprietary D: Reactive brominated
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Chemical Identity Proprietary D: Re
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Acute Dermal Irritation (OPPTS Harm
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• Prenatal Developmental Toxicity
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Gene Mutation in vitro C Bacterial
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• Chronic Toxicity to Freshwater
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Bioconcentration Fish: No data Daph
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Proprietary E: Tetrabromophthalate
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Proprietary E: Tetrabromophthalate
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• Reproduction and Fertility Effe
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GENOTOXICITY Conclusion: No availab
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Acute and Subchronic Toxicity to Te
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Proprietary F: Halogenated aryl est
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Proprietary F: Halogenated aryl est
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REPRODUCTIVE TOXICITY Conclusion: N
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• Neurotoxicity Screening Battery
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Basis for Conclusion: No pertinent
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Henry’s Law Constant: No data 9-1
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Anaerobic Biodegradation: No data P
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Proprietary G: Triaryl phosphate, i
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Acute Inhalation Toxicity (OPPTS Ha
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SUBCHRONIC TOXICITY Subchronic Oral
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• Prenatal Developmental Toxicity
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Composition of Proprietary G assaye
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Several components of the [Formulat
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As described in unvalidated robust
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Sediment/Water Biodegradation: No d
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Proprietary H: Halogenated aryl est
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Proprietary H: Halogenated aryl est
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REPRODUCTIVE TOXICITY Conclusion: N
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IMMUNOTOXICITY Conclusion: No avail
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Henry’s Law Constant: No data 11-
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Proprietary I: Organic phosphate es
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Proprietary I: Organic phosphate es
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CARCINOGENICITY Conclusion: No avai
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No studies were located that were r
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• Chronic Toxicity to Freshwater
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Explosivity: No data Corrosion Char
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Proprietary J: Aryl phosphate Exist
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Proprietary J: Aryl phosphate Synon
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Results: No deaths. Clinical signs
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As described in a robust summary, m
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third animal on days 2 and 3 only.
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however, identify target organs tha
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Basis for Conclusion: The only avai
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Basis for Conclusion: The available
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EPA proposed guidelines (Ref. 58).
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[Formulation 2] (typically 43% Prop
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No additional, pertinent acute toxi
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Proprietary J: Aryl phosphate CAS M
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Odor: No data Oxidation/Reduction C
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Bioconcentration Environmental Fate
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Degradation and Transport Photolysi
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Sediment Temp. T 1/2 Comments Refer
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Proprietary K: Aryl phosphate Exist
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Proprietary K: Aryl phosphate CAS M
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Proprietary L: Aryl phosphate Exist
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Proprietary L: Aryl phosphate Synon
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United States Environmental Protect
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