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EC number: 217-803-9 | CAS number: 1962-75-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
A subchronic oral gavage study in rats with the read-across chemical, n-butanol, indicates CNS depression as the critical effect of exposure. A number of dietary studies with the read-across chemical, terephthalic acid, indicate the urinary tract as the target organ following repeated exposures.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 125 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 10.05 mg/m³
- Study duration:
- subacute
- Species:
- rat
Additional information
There were no repeated exposure studies conducted with dibutyl terephthalate identified.
Given the rapid and complete metabolic conversion of dibutyl terephthalate, both in vitro and in vivo, to n-butanol and terephthalic acid, it is presumed that the repeated dose toxicity of dibutyl terephthalate is related to formation of these metabolites.
Male and female rats were administered n-butanol daily by gavage at 0, 30, 125 or 500 mg/kg bw/d for either 6 or 13 weeks. Dosing resulted in no significant changes in body weights or body weight gains, organ weights, food consumption, hematology, clinical chemistry or urinalysis. There were no gross or histopathological changes noted in any exposed group. Ataxia and hypoactivity (lasting less than 1 h) were present immediately following dose administration in both sexes at the highest dose level. The NOAEL reported in this study based on CNS effects was 125 mg/kg bw/d.
Several subchronic dietary studies in rats have been conducted with terephthalic acid. At dose levels of 3% for 90 days, terephthalic acid did not produce overt toxicity. Occult blood was found in the urine and crystalluria was seen after 90 days. Kidney weights were increased but no other organs were affected and this change was not thought to be biologically significant. At necropsy, mild to moderate epithelial hyperplasia of the bladder and evidence of chronic cystitis were noted. In a second study, male and female rats exposed to terephthalic acid in the diet for 15 weeks at up to 5% (w/w) displayed no overt signs of toxicity or mortality. Small reductions in body weights, but not food consumption, were seen at the highest dose level. Noteworthy findings were limited primarily to the urinary bladder of high dose males and included a high incidence of bladder stones. Microscopic examinations revealed proliferative changes characterized by thickening of the epithelium, and in some cases, narrowing of the lumen of the bladder. The NOAEL based on bladder effects for this study was 1.6% in the diet and corresponded to 980 mg/kg bw/d for males and 1186 mg/kg bw/d for females. In a third dietary study employing both male and female Wistar and CD rats, animals were exposed for 90 days at concentrations of 0, 0.03, 0.125, 0.5, 2.0 or 5.0%. Toxicity was evident in rats fed diets containing 0.5% and above of terephthalic acid. Chronic inflammatory lesions of the bladder and uethra were present in treated animals with the highest incidence occurring in rats at the 5% dose level. Bladder calculi were also found in rats fed 5% terephthalic acid, with higher incidence in Wistar versus CD rats. Based on body weight reductions, the NOAEL in this study was reported as 0.125%.
Inhalation
Male and female rats were exposed for 6 h/day, 5 days/week over a period of 4 weeks to terephthalic acid dust at concentrations of 1.03, 2.93 or 10.05 mg/m3. No adverse effects were observed in clinical obsersations, body weights or gross pathology findings. Male rats at the highest dose level showed decreased cholinesterase levels. Bilirubin levels were significantly decreased in low dose males and females but slightly increased in females in the high dose group. Plasma glucose levels were slightly increased in low dose males but mildly decreased in the medium and high dose groups. Similar changes were present in female rats. Changes noted above were all reversed in recovery group animals and were considered of minimal toxicological significance. In a functional observational battery (FOB) conducted during the last week of treatment, some (mainly transient) effects were noted in all treatment groups but generally displaying no clear dose-response and considered of low toxicological significance. No significant inflammatory or other lesions were observed in other treated animals.
Repeated dose toxicity: via oral route - systemic effects (target organ) neurologic: central nervous system
Justification for classification or non-classification
Based on the toxicological profiles of n-butanol and terephthalic acid, the metabolic products of dibutyl terephthalate, no classification for “Specific Target Organ Toxicity – Repeated Exposure” according to GHS is warranted.
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