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Diss Factsheets
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EC number: 201-618-5 | CAS number: 85-60-9
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Assessment of data available.
- Adequacy of study:
- key study
- Study period:
- November 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Assessment performed utilising all relevant data available.
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Qualifier:
- according to guideline
- Guideline:
- other: Assessment of relevant data
- Principles of method if other than guideline:
- A review has been undertaken utilising the relevant mammalian data available.
- GLP compliance:
- no
- Remarks:
- Conducted in compliance with ISO 9001 accreditation
- Radiolabelling:
- no
- Species:
- other: Not applicable
- Details on test animals or test system and environmental conditions:
- Not applicable
- Route of administration:
- other: Not applicable
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Not applicable.
- Remarks:
- Doses / Concentrations:
Not applicable - No. of animals per sex per dose / concentration:
- Not applicable
- Details on study design:
- Not applicable
- Details on dosing and sampling:
- Not applicable
- Preliminary studies:
- Not applicable
- Type:
- absorption
- Results:
- No evidence of absorption
- Type:
- distribution
- Results:
- No evidence to indicate distribution
- Type:
- metabolism
- Results:
- No definitive information about potential metabolism
- Type:
- excretion
- Results:
- Biotransformation of any absorbed substance is anticipated and the resulting metabolites could be eliminated either in urine or bile as well as faecal matter
- Details on absorption:
- Acute oral and dermal toxicity studies showed no treatment related effects and therefore provide no evidence of absorption by either route. In a repeated dose oral toxicity study, effects were observed with the livers of high dose animals, including increased organ weights, instances of hepatocellular hypertrophy, karyomegaly, multinucleated hepatocytes, increased mitoses and macrophages with distended cytoplasm were present in sinusoids and portal areas of livers from both sexes at the highest dose level. These observations coincided with slight changes to the serum chemistry parameters suggesting the liver as likely route or adsorption and metabolism of the substance. Exposure in both a screening reproductive toxicity test and developmental toxicity test indicates no effects to parent or F1 animals and no adverse effects were indicated by mutagenicity testing.
- Details on distribution in tissues:
- There is no experimental evidence to indicate distribution except, perhaps, to the liver in the repeated dose oral toxicity study. The Pow value obtained by testing may be suggestive of potential for accumulation, but bioaccumulation potential determined by QSAR suggests that accumulation is not a high concern.
- Details on excretion:
- There is no experimental evidence to indicate a route of excretion but the parent substance is not sufficiently water-soluble for elimination in its unchanged form in urine or bile, but may be eliminated in faecal matter. Biotransformation of any absorbed substance is, however, anticipated and the resulting metabolites could be eliminated either in urine or bile as well as faecal matter. As the parent substance is non-volatile and could not be eliminated via the lungs in expired air.
- Details on metabolites:
- The studies conducted provide no definitive information about potential metabolism, except the liver effects observed in the repeat dose are suggestive that biotransformation of any absorbed substance would be expected. The available mutagenicity data suggests that metabolism to genotoxic/ mutagenic metabolites is not a concern for this substance.
- Conclusions:
- The substance is a di cresol of molecular weight that does not preclude absorption. No specific predictions about toxicokinetic behaviour can be made from the chemical structure. The substance is a non-volatile powder of non-respirable particle size, so inhalation exposure is not anticipated. Non-enzymatic hydrolysis is unlikely so exposure to degradants is not applicable.
- Executive summary:
The substance is a di cresol of molecular weight that does not preclude absorption. No specific predictions about toxicokinetic behaviour can be made from the chemical structure. The substance is a non-volatile powder of non-respirable particle size, so inhalation exposure is not anticipated. Non-enzymatic hydrolysis is unlikely so exposure to degradants is not applicable.
Absorption:
Acute oral and dermal toxicity studies showed no treatment related effects and therefore provide no evidence of absorption by either route. In a repeated dose oral toxicity study, effects were observed with the livers of high dose animals, including increased organ weights, instances of hepatocellular hypertrophy, karyomegaly, multinucleated hepatocytes, increased mitoses and macrophages with distended cytoplasm were present in sinusoids and portal areas of livers from both sexes at the highest dose level. These observations coincided with slight changes to the serum chemistry parameters suggesting the liver as likely route or adsorption and metabolism of the substance. Exposure in a screening reproductive toxicity test and developmental toxicity test indicate no effects to parent or F1 animals and no adverse effects were indicated by mutagenicity testing.
Distribution:
There is no experimental evidence to indicate distribution except, perhaps, to the liver in the repeated dose oral toxicity study. The Pow value obtained by testing may be suggestive of potential for accumulation, but bioaccumulation potential determined by QSAR suggests that accumulation is not a high concern.
Metabolism:
The studies conducted provide no definitive information about potential metabolism, except the liver effects observed in the repeat dose are suggestive that biotransformation of any absorbed substance would be expected. The available mutagenicity data suggests that metabolism to genotoxic/ mutagenic metabolites is not a concern for this substance.
Excretion:
There is no experimental evidence to indicate a route of excretion but the parent substance is not sufficiently water-soluble for elimination in its unchanged form in urine or bile, but may be eliminated in faecal matter. Biotransformation of any absorbed substance is, however, anticipated and the resulting metabolites could be eliminated either in urine or bile as well as faecal matter. As the parent substance is non-volatile and could not be eliminated via the lungs in expired air.
Reference
Description of key information
A review has been undertaken utilising the relevant mammalian data available.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
The substance is a di cresol of molecular weight that does not preclude absorption. No specific predictions about toxicokinetic behaviour can be made from the chemical structure. The substance is a non-volatile powder of non-respirable particle size, so inhalation exposure is not anticipated. Non-enzymatic hydrolysis is unlikely so exposure to degradants is not applicable. Absorption rate is proposed as 100% for the purposes of worst case assesssment.
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