National Toxicology Program

Selected toxicity information from HSDB, one of the National Library of Medicine's databases. ¹

Names (NTP)

• Ethylenebis(tetrabromophthalimide)
• 1H-ISOINDOLE-1,3(2H)-DIONE, 2,2'-(1,2-ETHANEDIYL)BIS(4,5,6,7-TETRABROMO- (9CI)
• SAYTEX BT-93

Human Toxicity Excerpts

• None found

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Non-Human Toxicity Excerpts

• LABORATORY ANIMALS: Acute Exposure: The test material (0.5 g) was applied to intact and abraded skin of 6 white rabbits. The test material was covered with an occlusive dressing and remained in contact for 24 hr. Skin readings were made at 24 and 72 hr post-application. All rabbits at both readings scored 0 for erythema, eschar, and edema formation. [European Chemicals Bureau; IUCLID Dataset, N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide) (32588-76-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein&DEPUIS=autre as of November 8, 2004. ]**PEER REVIEWED**
  
• LABORATORY ANIMALS: Acute Exposure: The test article was instilled in the right eye of 6 New Zealand white rabbits. Observations were recorded at 1, 24, 48, and 72 hr and on Day 7 following treatment. At 1 hr after instillation, conjunctival redness was detected in 5 animals with a score of 1 and in 1 animal with a score of 2 at 24 hours. Discharge (score = 1) was noted in 2 animals. All 6 animals were negative for chemosis. All 6 animals scored 0 for corneal lesions and iris effects. All scores at other time points were negative. [European Chemicals Bureau; IUCLID Dataset, N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide) (32588-76-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein&DEPUIS=autre as of November 8, 2004. ]**PEER REVIEWED**
  
• LABORATORY ANIMALS: Subchronic or Prechronic Exposure: The test article was fed to Sprague Dawley male rats (n=10/group) at 0, 0.01, 0.1 and 1% of the diet for 28 days. No mortality occurred during the study. No clinical signs of toxicity were observed. Mean body weights, body weight gains, food consumption and organ weights were not affected by treatment. Organs weighed at necropsy were liver, heart, spleen, kidney, and testes. Hematology and serum chemistry parameters were not affected by treatment. No gross or microscopic lesions attributable to test article were detected at necropsy or on light microscopy. The 28-day NOEL was 1% of the diet. This is estimated to be /about/ 1,000 mg/kg/day using the assumption of consumption of 25 g diet per 250 g rat per day. [EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans. Available from: http://www.epa.gov/chemrtk/viewsrch.htm on Phthalimide, N,N'-ethylenebis[tetrabromo- as of November 4, 2004. ]**PEER REVIEWED**
  
• LABORATORY ANIMALS: Subchronic or Prechronic Exposure: /Saytex BT 93/ was admistered to 4 groups of Sprague Dawley rats (n=15/sex/group) at 0, 0.01, 0.1 and 1.0% of the diet for 90 days followed by 46 days during which the rats were fed control diet. No changes in hematology or serum chemistry values related to treatment were detected on study days 0, 45, 92. No effect of treatment was found on urinalysis (day 0, 45 and 90). The mean relative and absolute organ weights of the liver, kidney, heart, and thyroids from the control and 1.0% groups were statistically comparable. Several animals died /during the/ test from non-test article related causes (most deaths were related to collection of blood for hematology and serum chemistry evaluations). Gross necropsy from animals dying /during/ test and sacrificed on days 92, 134, 135 and 136 revealed no test article-related gross lesions. No test article related lesions were detected on histopathology. The 90-day NOEL was 1% of the diet. This is estimated to be /about/ 1,000 mg/kg/day using the assumption of consumption of 25 g diet per 250 g rat per day. [EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans. Available from: http://www.epa.gov/chemrtk/viewsrch.htm on Phthalimide, N,N'-ethylenebis[tetrabromo- as of November 4, 2004. ]**PEER REVIEWED**
  
• LABORATORY ANIMALS: Developmental or Reproductive Toxicity: The test article was administered to 4 groups of 25 mated female Sprague Dawley rats by gavage in corn oil at doses of 0, 100, 500 or 1000 mg/kg/day on gestation days 6-15. The animals were observed daily for clinical signs of toxicity. Body weights were measured on gestation days 0, 6, 9, 12, 16, and 20. Food consumption was measured daily. All females were sacrificed on gestation day 20 and subjected to a cesarean section. Fetuses were individually weighed, sexed, and examined for external, visceral and skeletal abnormalities. No maternal mortality or clinical signs of toxicity were observed during the study. No treatment-related differences were noted among the groups with respect to maternal body weights, food consumption, necropsy or cesarean section data. No treatment-induced fetal malformations or developmental variations were detected. The maternal and fetal NOEL >/=1,000 mg/kg/day. [EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans. Available from: http://www.epa.gov/chemrtk/viewsrch.htm on Phthalimide, N,N'-ethylenebis[tetrabromo- as of November 4, 2004. ]**PEER REVIEWED**
  
• LABORATORY ANIMALS: Developmental or Reproductive Toxicity: /Saytex BT 93/ was administered to two groups of 20 mated female New Zealand White rabbits each by gavage in methyl cellulose at dose of 0 or 1,000 mg/kg/day on gestation days 7-19. The animals were observed daily for clinical signs of toxicity. Body weights were measured on gestation days 0, 7, 10, 13, 19, 24 and 29. Food consumption was measured daily. All females were sacrificed on gestation day 29 and subjected to a cesarean section. Fetuses were individually weighed sexed and examined for external, visceral and skeletal abnormalities. No maternal mortality, abortions or clinical signs of toxicity were observed during the study. Maternal body weights, weight gain, food consumption, necropsy observations and cesarean section data were generally comparable among the groups. No treatment-related /malformations or developmental variations were observed. The maternal and fetal NOEL was 1,000 mg/kg/day. [EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans. Available from: http://www.epa.gov/chemrtk/viewsrch.htm on Phthalimide, N,N'-ethylenebis[tetrabromo- as of November 4, 2004. ]**PEER REVIEWED**
  
• GENOTOXICITY: Salmonella strains TA1535, TA1537, TA1538, TA98 and TA100 and E. Coli, WP2 uvrA were used in this modification of the Ames assay. All strains were tested /at 10, 50, 100, 500, 1000, 5000 ug/plate/ with and without metabolic activation. Both solvent and positive controls were used. The solvent was DMSO. The positive controls were 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, N-ethyl-N'-nitro-N-nitrosoguanidine, 9-Aminoacridine, 2-Nitrofluorene, and 2-Aminoantracene. No mutagenic activity was detected in the 5 Salmonella strains or in the E.coli strain. The positive controls responded as expected. [EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans. Available from: http://www.epa.gov/chemrtk/viewsrch.htm on Phthalimide, N,N'-ethylenebis[tetrabromo- as of November 4, 2004. ]**PEER REVIEWED**
  
• GENOTOXICITY: Salmonella strains TA1535, 1537, 1538, 98 and 100 and Saccharomyces D4 were utilized, and tested /at 1, 10, 50, 100, 500, 1000 ug/plate/ both with and without metabolic activation. Solvent and negative controls were included. The solvent was DMSO. Five different positive controls were utilized. Each strain was tested in duplicate. No mutagenic activity was associated with the test article. [EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans. Available from: http://www.epa.gov/chemrtk/viewsrch.htm on Phthalimide, N,N'-ethylenebis[tetrabromo- as of November 4, 2004. ]**PEER REVIEWED**
  

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Human Toxicity Values

• None found

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Non-Human Toxicity Values

• LD50 Rat (Sherman-Wistar) oral >7500 mg/kg bw [EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans. Available from: http://www.epa.gov/chemrtk/viewsrch.htm on Phthalimide, N,N'-ethylenebis[tetrabromo- as of November 4, 2004. ]**PEER REVIEWED**
  
• LC50 Rat inhalation >203 mg/L/1 hr [European Chemicals Bureau; IUCLID Dataset, N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide) (32588-76-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein&DEPUIS=autre as of November 8, 2004. ]**PEER REVIEWED**
  

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Absorption, Distribution and Excretion

• 14C-labelled BT93 was administered orally by gavage in corn oil to 5 female Sprague-Dawley rats for 14 consecutive days. Two rats were sacrificed 24 hr after the last dose; remainder sacrificed 7, 14, and 30 days after the last dose. Liver, kidney, brain, leg muscle and body fat were collected at each sacrifice. Urine, feces and expired air was collected 24 hr after the last dose. The compound was excreted mainly in the feces (approximately 65% of the total dose). Approximately 15% of the total dose was found in the urine. The amount of the radiolabel excreted in expired air was negligible. A minor trace amount of 14C-label was temporarily detected in tissues; residues were <0.5 ppm in any tissue. Tissues from animals sacrificed during the withdrawal period showed a dissipation of residue levels in all tissues within the 30 withdrawal period. Kidney level went from 0.32 ppm 24 hr after the last dose to 0.043 ppm at day 30 post dosing; liver went from 0.424 ppm 24 hr after the last dose to 0.024 ppm at day 30 post dosing. [European Chemicals Bureau; IUCLID Dataset, N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide) (32588-76-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein&DEPUIS=autre as of November 8, 2004. ]**PEER REVIEWED**
  

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Metabolism/Metabolites

• None found

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TSCA Test Submissions

• None found

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Footnotes

¹ Source: the National Library of Medicine's Hazardous Substance Database, 10/28/2007.