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Diss Factsheets
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EC number: 201-066-5 | CAS number: 77-89-4
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1950
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 950
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Three groups of 20 rats each (approximately 12 weeks of age) received diets containing the test substance (ATBC) at concentrations of 200, 2000 or 20,000 ppm. A group of 40 rats received the basal diet without test substance and served as the control group. Animals had access to their respective diets ad libitum for approximately two years. Animals were observed daily for behavior and general condition and body weights were measured weekly. All animals that died spontaneously during the experiment and those surviving to study termination were subjected to a necropsy and tissues were examined histologically. Because of unexplained transient depression of the rate of growth of all three experimental groups from week 5 to 15, two additional groups of 10 rats each received the test substance in the diet at concentrations of 200 and 2000 ppm and one group of 20 rats that served as the control, received the untreated diet for one year. All animals in these additional groups that died spontaneously and those sacrificed at the end of the one year treatment period were studied for pathological changes.
- GLP compliance:
- no
- Remarks:
- pre-dates GLP
Test material
- Reference substance name:
- Tributyl O-acetylcitrate
- EC Number:
- 201-067-0
- EC Name:
- Tributyl O-acetylcitrate
- Cas Number:
- 77-90-7
- Molecular formula:
- C20H34O8
- IUPAC Name:
- Acetyltributylcitrate
Constituent 1
- Specific details on test material used for the study:
- purity = 99.4%
Test animals
- Species:
- rat
- Strain:
- Sherman
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 12 weeks of age at start of study
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Three groups of 20 rats each (approximately 12 weeks of age) received diets containing the test substance (ATBC) at concentrations of 200, 2000 or 20,000 ppm. A group of 40 rats received the basal diet without test substance and served as the control group. Animals had access to their respective diets ad libitum for approximately two years.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Post exposure period:
- none
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 200 ppm (nominal)
- Dose / conc.:
- 2 000 ppm (nominal)
- Dose / conc.:
- 20 000 ppm (nominal)
- No. of animals per sex per dose:
- 20 for each test dose; 40 with untreated diet as control
- Control animals:
- yes, plain diet
- Details on study design:
- Animals were observed daily for behavior and general condition and body weights were measured weekly. All animals that died spontaneously during the experiment and those surviving to study termination were subjected to a necropsy and tissues were examined histologically. Because of unexplained transient depression of the rate of growth of all three experimental groups from week 5 to 15, two additional groups of 10 rats each received the test substance in the diet at concentrations of 200 and 2000 ppm and one group of 20 rats that served as the control, received the untreated diet for one year. All animals in these additional groups that died spontaneously and those sacrificed at the end of the one year treatment period were studied for pathological changes.
Examinations
- Observations and examinations performed and frequency:
- Animals were observed daily for behavior and general condition and body weights were measured weekly.
- Sacrifice and pathology:
- All animals that died spontaneously during the experiment and those surviving to study termination were subjected to a necropsy and tissues were examined histologically.
- Statistics:
- not stated
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related clinical observations.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Twelve of the 60 rats fed test diets and eight of the 40 control rats died prior to scheduled sacrifice. There was no significant difference in time of death or percentage mortality among the three treated groups and controls.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the main study, a transient reduction in body weight gain was observed in animals in all three treated groups, 200, 2000 and 20000 ppm. This decrease in body weight gain was not seen in the additional study of animals treated for one year at dietary concentrations of 200 and 2000 ppm. Since this finding was not reproducible it is considered to be and artifact. Statistical analysis indicated that there were no significant differences between the body weights of the treated animals compared to the concurrent controls.
- Description (incidence and severity):
- Inflammatory disease of the lungs was the most frequent finding necropsy of these animals, it is likely that this was caused by infection rather than treatment with ATBC. Lymphoid tumors of the pleural and abdominal cavities, with some infiltration of the associated organs, were seen in both treated and control animals at comparable rates and, therefore, were not considered to be treatment-related. Careful examination of the endocrine system did not reveal evidence of abnormality in any of the animals. There were no significant differences between treated and control animals in comparisons of the pathological findings.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: NOAEL indicated as > 1000 mg/kg/day
- Remarks on result:
- other:
- Remarks:
- Under the conditions of this study, the NOAEL appears to be 20,000 ppm (estimated as 1000 mg/kg/day) ATBC in the diet; however, considering the pre-GLP timing of the study and the lack of experimental detail available in the study report, a more conservative and appropriate NOAEL may be 2000 ppm (estimated as 100 mg/kg/day) ATBC in the diet.
Applicant's summary and conclusion
- Conclusions:
- ATBC was tested in a 2 year feeding study in rats. No systemic toxicity observed up to 20,000 ppm (1000 mg/kg/day). NOAEL determined to be greater than or equal to 100 mg/kg/day; LOAEL = 1000 mg/kg/day.
- Executive summary:
ATBC was tested in a 2 year feeding study in rats. No systemic toxicity observed up to 20,000 ppm (1000 mg/kg/day). NOAEL determined to be greater than or equal to 100 mg/kg/day; LOAEL = 1000 mg/kg/day.
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