Environmental Profiles of Chemical Flame-Retardant Alternatives for

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CARCINOGENICITY Conclusion: The available carcinogenicity data were judged adequate to meet the endpoint. Basis for Conclusion: Increased tumor incidences were observed in a combined chronic toxicity/carcinogenicity assay in rats exposed to Proprietary A in the diet (Ref. 24). • Carcinogenicity (OPPTS Harmonized Guideline 870.4200; OECD Guideline 451) No studies of this type were located. Combined Chronic Toxicity/Carcinogenicity (OPPTS Harmonized Guideline 870.4300; OECD Guideline 453) A 2-year feeding bioassay by Ref. 24 was consistent with this guideline. Type: Combined oral chronic toxicity and carcinogenicity assay Species, strain, sex, number: Rat, Sprague-Dawley, 60/sex/group Purity: 95% Doses: 0, 5, 20, and 80 mg/kg body weight/day Vehicle: None other than feed Route: In feed; diets blended weekly to achieve target doses Exposure duration, frequency: 2, ad lib Method: See description above under Chronic Toxicity Results: The following neoplastic changes compared to controls were statistically significant (p
Basis for Conclusion: The delayed neurotoxicity component is satisfied by the existing data, but a developmental toxicity study by Ref. 59 that included postnatal behavioral examinations did not fully satisfy the developmental neurotoxicity component. Proprietary A gave negative results in single acute and subchronic oral delayed neurotoxicity studies in hens and in limited postnatal testing in rats exposed during gestation. A 2-year feeding bioassay in rats by Ref. 24, discussed above under the Chronic Toxicity and Carcinogenicity endpoints, reported no lesions of the cervical spinal cord, but a slight (not statistically significant) increase in the incidence of gliomas of the brain in rats exposed to Proprietary A at 80 mg/kg/day. The study authors could not determine whether this effect was related to exposure. Delayed Neurotoxicity Conclusion: The available delayed neurotoxicity data were judged adequate to meet the endpoint. Basis for Conclusion: Several acute studies and one subchronic study for delayed neurotoxicity in the hen, summarized below, give no evidence of acute cholinergic toxicity, inhibition of neurotoxic esterase (NTE) activity, or delayed neurotoxicity for Proprietary A. These studies, performed prior to the existence of the guidelines, do not entirely conform to current guidelines, and may lack detail such as the purity of the Proprietary A sample. The lack of significant NTE inhibition following dosing with 10,000 mg/kg suggests that no additional testing for delayed neurotoxicity is needed for Proprietary A. • Acute and 28-Day Delayed Neurotoxicity of Organophosphorus Substances (OPPTS Harmonized Guideline 870.6100; OECD Guideline 418, 419) Unpublished industrial acute (1- or 5-day) and subchronic (90-day) delayed neurotoxicity assays, which pre-date the guideline, are missing some details. One acute study employed a gavage dose 5 times higher than now specified under the guideline. The subchronic assay had a longer duration and a larger group size than specified under the guideline. Critical Studies Type: Acute oral delayed neurotoxicity Species, strain, sex, number: Hen, White Leghorn, 4/dose Purity: [Formulation 2], purity not reported, clear colorless liquid Doses: 420 mg/kg (highest dose specified in protocol) Vehicle: test substance diluted 50% in corn oil Positive control: 90 or 120 mg/kg/day tri-ortho-tylol phosphate (TOCP) 4-18
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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
Page 117 and 118: Critical Studies Type: Acute oral d
Page 119 and 120: English summary and therefore could
Page 121 and 122: 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: Combined Chronic Toxicity/Carcinoge
Page 171 and 172: histopathological effects in the ne
Page 173 and 174: Immunotoxicity (OPPTS Harmonized Gu
Page 175 and 176: C In vitro Mammalian Cell Gene Muta
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
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Bioconcentration Fish: No data Daph
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Flame Retardant Alternatives Propri
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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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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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