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Diss Factsheets
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EC number: 458-930-1 | CAS number: -
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC (2003; 2010)
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 882 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation performed as described in ECHA (2008)
- AF for dose response relationship:
- 1
- Justification:
- Informed AF: substances that produce no adverse effects at a limit dose of 1000 mg/kg bw/d are non-hazardous, with no classification required for potential effects on human health.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF for oral route (allometric scaling, rat)
- AF for other interspecies differences:
- 1
- Justification:
- Informed AF for worker population: it is unlikely that the toxicokinetics and toxicodymics of Ceraphyl 55 will differ markedly between rats and humans, with any variations that are present accounted for by the multiplication product of the AFs for inter- and intraspecies variability (ECETOC, 2010). This is consistent with ECHA guidance indicating that care should be taken to avoid “double counting” when multiplying individual AFs (ECHA, 2010).
- AF for intraspecies differences:
- 3
- Justification:
- Informed AF for workers: the applied AF reflects the 90thpercentile from analyses of human toxicokinetic and toxicodynamic data for men and women of differing ages and disease states, and is scientifically supportable (ECETOC, 2003; 2010). Furthermore while human polymorphisms may lead to variability in toxicokinetics, the effect of such variations is minor at low (non-saturating) substrate concentrations (ECETOC, 2010). The overall AF derived here will result in low internal exposures that will limit any intraspecies differences in toxicological response.
- AF for the quality of the whole database:
- 1
- Justification:
- Informed AF: data originate from a modern, well reported, GLP-compliant guideline study.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC (2003; 2010)
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal and oral absorbtion assumed to be equivalent at 100% in accordance with ECHA guidance
- AF for dose response relationship:
- 1
- Justification:
- Informed AF: substances that produce no adverse effects at a limit dose of 1000 mg/kg bw/d are non-hazardous, with no classification required for potential effects on human health.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for dermal route (allometric scaling, rat)
- AF for other interspecies differences:
- 1
- Justification:
- Informed AF for worker population: it is unlikely that the toxicokinetics and toxicodymics of Ceraphyl 55 will differ markedly between rats and humans, with any variations that are present accounted for by the multiplication product of the AFs for inter- and intraspecies variability (ECETOC, 2010). Use of AF=1 is also consistent with ECHA guidance indicating that care should be taken to avoid “double counting” when multiplying individual AFs (ECHA, 2010).
- AF for intraspecies differences:
- 3
- Justification:
- Informed AF for workers: the applied AF reflects the 90thpercentile from analyses of human toxicokinetic and toxicodynamic data for men and women of differing ages and disease states, and is scientifically supportable (ECETOC, 2003; 2010). Furthermore while human polymorphisms may lead to variability in toxicokinetics, the effect of such variations is minor at low (non-saturating) substrate concentrations (ECETOC, 2010). The overall AF derived here will result in low internal exposures that will limit any intraspecies differences in toxicological response.
- AF for the quality of the whole database:
- 1
- Justification:
- Informed AF: data originate from a modern, well reported, GLP-compliant guideline study.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Where relevant data are available, local and systemic DNELs for worker exposure to Ceraphyl 55 have been developed based on results of animal studies obtained for Ceraphyl 55 and assessment factors (AF) recommended by ECHA (2012: Guidance on Information Requirements and Chemical Safety assessment: chapter R.8 – characterisation of dose [concentration] - response for human health. pp 32, ECHA, Helsinki, November 2012 2010), ECETOC (2003: Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86, pp 86, ECETOC, Brussels, February 2003) and ECETOC (2010: Guidance on Assessment Factors to Derive a DNEL. Technical Report No. 110, pp 198, ECETOC, Brussels, October 2010).
Acute toxicity
A DNEL for acute toxicity should be derived if a hazard leading to acute toxicity (e. g. C&L) has been identified and there is a potential for high peak exposures. The TGD notes that such peaks are normally associated with inhalation exposure but are less common for skin contact and ingestion (ECHA, Appendix R.8-8). Results for acute oral and acute dermal toxicity both show LD50 values greater than 2000 mg/kg bwt (i. e. no classification required). The derivation of DNELs for acute toxicity is therefore not appropriate or necessary for Ceraphyl 55.
Irritation
Ceraphyl 55 is not classified as an eye or skin irritant. Results are available from four modern, GLP-compliant, guideline studies that have assessed the skin and eye irritation potential of Ceraphyl 55 in the rabbit. Only minimal, transient dermal response observed. Eye irritation studies showed minimal conjunctival redness that resolved rapidly.Sensitisation
Results are available for 3 well-conducted mouse local lyph node assays. The laboratory eports do not provide EC3 values but based on Stimulation Index (SI) data presented it is estimated that the EC3 value would fall in the range 10-35%. This would suggest a weak to moderate potential for skin sensitization; this is also supported by a negative Buehler sensitization study in guinea pigs.
Skin sensitization is a local effect. Although the effect is exerted through a threshold mode of action, the available data do not allow reliable identification of a threshold or a definitive assessment of potency. Ceraphyl 55 is classified as a Category 1 sensitiser. As derivation of a DNEL is not possible protective measures will be subject to a qualitative assessment.Long-term systemic effects
The potential to cause long-term systemic effects can judged from results of a repeated dose, 28-day) oral toxicity study in rats with Ceraphyl 55. For Ceraphyl 55, the following NOAELs are presented in the IUCLID dossier:
sub-acute effects: rat oral NOAEL = 1000 mg/kg bw/day
Oral
Dose descriptor
A rat oral sub-acute NOAEL of 1000 mg/kg bw/d will be used with appropriate modification to derive an oral DNEL for Ceraphyl 55. No additional correction of the animal NOAEL is required.
In the absence of information to the contrary it is assumed that oral uptake and dermal uptake are identical (ECHA, Section R.8.4.2, Ad2).
DNELworker-oral = 1000 / 72 = 14 mg/kg bw/d
Dermal
Dose descriptor
A rat oral sub-acute NOAEL of 1000 mg/kg bwt/d will be used with appropriate modification to derive a dermal DNEL for Ceraphyl 55.
Modification of dose descriptor: No additional correction of the animal NOAEL is required.
In the absence of information to the contrary it is assumed that oral uptake and dermal uptake are identical (ECHA, Section R.8.4.2, Ad2).
For workers, no modification of the NOAEL is required.
DNELworker-dermal = 1000 / 72 = 14 mg/kg bw/d
Inhalation
Dose descriptor
A rat oral NOAEL of 1000 mg/kg bwt/d will be used with appropriate modification to derive an inhalation DNEL for Ceraphyl 55
Modification of dose descriptor. No additional correction of the animal NOAEL is required.
In the absence of data to the contrary, it has been assumed that the extent of inhalation uptake Ceraphyl 55 is double that following oral exposure (ECHA, Section R.8.4.2, Ad2).
The corrected inhalatory NOAEC is calculated as follows:
NOAECinhalation = NOAELoral x 1/sRVrat x ABSoral-rat/ABSinh-human x sRVhuman/wRVhuman
= 1000 x 1/0.38 x 1/2 x 6.7/10
Corrected inhalation NOAECworker = 882 mg/m3
DNELworker-inhalation = 882 / 18 = 49 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC (2003; 2010)
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 882 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Modification of dose descriptor.In the absence of data to the contrary, it has been assumed that the extent of inhalation uptake Ceraphyl 55 is double that following oral exposure (ECHA, Section R.8.4.2, Ad2).
- AF for dose response relationship:
- 1
- Justification:
- Informed AF: substances that produce no adverse effects at a limit dose of 1000 mg/kg bw/d are non-hazardous, with no classification required for potential effects on human health.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 5
- Justification:
- Informed AF for general population: the applied AF reflects the 90thpercentile from analyses of human toxicokinetic and toxicodynamic data for men and women of differing ages and disease states, and is scientifically supportable (ECETOC, 2003; 2010). Furthermore while human polymorphisms may lead to variability in toxicokinetics, the effect of such variations is minor at low (non-saturating) substrate concentrations (ECETOC, 2010). The overall AF derived here will result in low internal exposures that will limit any intraspecies differences in toxicological response.
- AF for other interspecies differences:
- 1
- Justification:
- Informed AF for general populationpopulation: it is unlikely that the toxicokinetics and toxicodymics of this substance will differ markedly between rats and humans, with any variations that are present accounted for by the multiplication product of the AFs for inter- and intraspecies variability (ECETOC, 2010). This is consistent with ECHA guidance indicating that care should be taken to avoid “double counting” when multiplying individual AFs (ECHA, 2010).
- AF for intraspecies differences:
- 1
- Justification:
- Default AF for inhalation route (no allometric scaling necessary)
- AF for the quality of the whole database:
- 1
- Justification:
- Informed AF: data originate from a modern, well reported, GLP-compliant guideline study.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC (2003; 2010)
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal and oral absorbtion assumed to be equivalent at 100% in accordance with ECHA guidance
- AF for dose response relationship:
- 1
- Justification:
- Informed AF: substances that produce no adverse effects at a limit dose of 1000 mg/kg bw/d are non-hazardous, with no classification required for potential effects on human health.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for dermal route (allometric scaling, rat)
- AF for other interspecies differences:
- 1
- Justification:
- Informed AF for general population: it is unlikely that the toxicokinetics and toxicodymics of Ceraphyl 55 will differ markedly between rats and humans, with any variations that are present accounted for by the multiplication product of the AFs for inter- and intraspecies variability (ECETOC, 2010). Use of AF=1 is also consistent with ECHA guidance indicating that care should be taken to avoid “double counting” when multiplying individual AFs (ECHA, 2010).
- AF for intraspecies differences:
- 5
- Justification:
- Informed AF for general population: the applied AF reflects the 90thpercentile from analyses of human toxicokinetic and toxicodynamic data for men and women of differing ages and disease states, and is scientifically supportable (ECETOC, 2003; 2010). Furthermore while human polymorphisms may lead to variability in toxicokinetics, the effect of such variations is minor at low (non-saturating) substrate concentrations (ECETOC, 2010). The overall AF derived here will result in low internal exposures that will limit any intraspecies differences in toxicological response.
- AF for the quality of the whole database:
- 1
- Justification:
- Informed AF: data originate from a modern, well reported, GLP-compliant guideline study.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Dose descriptor starting point:
- other: Experimental data insufficient to define potency and/or a reliable dose descriptor
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC (2003; 2010)
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No additional correction of the animal NOAEL is required.
- AF for dose response relationship:
- 1
- Justification:
- Informed AF: substances that produce no adverse effects at a limit dose of 1000 mg/kg bw/d are non-hazardous, with no classification required for potential effects on human health.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for dermal route (allometric scaling, rat)
- AF for other interspecies differences:
- 1
- Justification:
- Informed AF for general population: it is unlikely that the toxicokinetics and toxicodymics of Ceraphyl 55 will differ markedly between rats and humans, with any variations that are present accounted for by the multiplication product of the AFs for inter- and intraspecies variability (ECETOC, 2010). Use of AF=1 is also consistent with ECHA guidance indicating that care should be taken to avoid “double counting” when multiplying individual AFs (ECHA, 2010).
- AF for intraspecies differences:
- 5
- Justification:
- Informed AF for general population: the applied AF reflects the 90thpercentile from analyses of human toxicokinetic and toxicodynamic data for men and women of differing ages and disease states, and is scientifically supportable (ECETOC, 2003; 2010). Furthermore while human polymorphisms may lead to variability in toxicokinetics, the effect of such variations is minor at low (non-saturating) substrate concentrations (ECETOC, 2010). The overall AF derived here will result in low internal exposures that will limit any intraspecies differences in toxicological response.
- AF for the quality of the whole database:
- 1
- Justification:
- Informed AF: data originate from a modern, well reported, GLP-compliant guideline study.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Discussion
Where relevant data are available, local and systemic DNELs for worker exposure to Ceraphyl 55 have been developed based on results of experimental studies with Ceraphyl 55 and use of assessment factors (AF) recommended by ECHA (2012: Guidance on Information Requirements and Chemical Safety assessment: chapter R.8 – characterisation of dose [concentration] - response for human health. pp 32, ECHA, Helsinki, December 2012), ECETOC (2003: Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86, pp 86, ECETOC, Brussels, February 2003) and ECETOC (2010: Guidance on Assessment Factors to Derive a DNEL. Technical Report No. 110, pp 198, ECETOC, Brussels, October 2010).
Acute toxicity
A DNEL for acute toxicity should be derived if a hazard leading to acute toxicity (e. g. hazard classification under CLP) has been identified and there is a potential for high peak exposures. The TGD notes that such peaks are normally associated with inhalation exposure but are less common for skin contact and ingestion (ECHA, Appendix R.8-8). Results for acute oral and acute dermal toxicity both give LD50 values greater than 2000 mg/kg bwt (i. e. no classification required).
The derivation of DNELs for acute toxicity is therefore not appropriate or necessary for Ceraphyl 55.
Irritation
Ceraphyl 55 is not classified as an eye or skin irritant. Results are available from four modern, GLP-compliant, guideline studies that have assessed the skin and eye irritation potential of Ceraphyl 55 in the rabbit.Only minimal, transient dermal response observed. Eye irritation studies showed minimal conjunctival redness that resolved rapidly.
Sensitisation
Results are available for 3 well-conducted mouse local lyph node assays. The laboratory eports do not provide EC3 values but based on Stimulation Index (SI) data presented it is estimated that the EC3 value would fall in the range 10-35%. This would suggest a weak to moderate potential for skin sensitization; this is also supported by a negative Buehler sensitization study in guinea pigs.
Skin sensitization is a local effect. Although the effect is exerted through a threshold mode of action, the available data do not allow reliable identification of a threshold or a definitive assessment of potency. Ceraphyl 55 is classified as a Category 1 sensitiser. As derivation of a DNEL is not possible protective measures will be subject to a qualitative assessment
Long-term systemic effects
The potential to cause long-term systemic effects can judged from results of repeated dose (28-day) oral toxicity study with Ceraphyl 55. For Ceraphyl 55, the following NOAELs are presented in the IUCLID dossier:
sub-acute effects: rat oral NOAEL = 1000 mg/kg bwt/day
Oral
Dose descriptor
A rat oral sub-acute NOAEL of 1000 mg/kg bw/d will be used with appropriate modification to derive an oral dermal DNEL for Ceraphyl 55.
Modification of dose descriptor: No additional correction of the animal NOAEL is required.
For the general population, no modification of the NOAEL is required.
DNELgeneral population-oral = 1000 / 120 = 8.3 mg/kg bwt/d
Dermal
Dose descriptor
A rat oral sub-acute NOAEL of 1000 mg/kg bw/d will be used with appropriate modification to derive a dermal DNEL for Ceraphyl 55.
Modification of dose descriptor: No additional correction of the animal NOAEL is required.
In the absence of information to the contrary it is assumed that oral uptake and dermal uptake are identical (ECHA, Section R.8.4.2, Ad2).
For workers, no modification of the NOAEL is required.
DNELgeneral population-dermal = 1000 / 120 = 8.3 mg/kg bwt/d
Inhalation
Dose descriptor
A rat oral NOAEL of 1000 mg/kg bw/d will be used with appropriate modification to derive an inhalation DNEL for Ceraphyl 55
Modification of dose descriptor.In the absence of data to the contrary, it has been assumed that the extent of inhalation uptake Ceraphyl 55 is double that following oral exposure (ECHA, Section R.8.4.2, Ad2).
The corrected inhalatory NOAEC is calculated as follows:
NOAECinhalation = NOAELoral x 1/sRVrat x ABSoral-rat/ABSinh-human x sRVhuman/wRVhuman
= 1000 x 1/0.38 x 1/2 x 6.7/10
Corrected inhalation NOAECworker = 882 mg/m3
DNELgeneral population-inhalation = 882 / 30 = 29 mg/m3
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.