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EC number: 700-080-3 | CAS number: 752225-55-1
- 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
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- LOAEL
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Dose descriptor:
- other: LOAEL
Workers - Hazard for the eyes
Additional information - workers
Correction of dose descriptors if needed (for example route-to-route extrapolation), application of assessment factors and derivation of the endpoint specific DN(M)EL
Correction of dose descriptors may be needed for the following situations:
1. If for a given human exposure route there is a dose descriptor for the same route in experimental animals but for that particular exposure route there is a difference in bioavailability between experimental animals and humans at the relevant level of exposure.
2. If for a given human exposure route there is not a dose descriptor for the same route (in experimental animals or humans).
3. Differences in human and experimental exposure conditions.
4. Differences in respiratory volumes between experimental animals (at rest) and humans (light activity).
In case of Cargill BP-A, no difference in bioavailability is expected for the oral and the dermal route. For the relevant route of human exposure, which would be the dermal route, limited data is available (acute dermal toxicity on surrogate chemical ESBO and skin irritation on Cargill BP-A). These data do not indicate a difference in effects between both exposure routes, therefore the data on oral toxicity testing can be used to assess dermal DNELs.
Human exposure to Cargill BP-A is considered to be negligible, as the substance is a monomer and incorporated in a polymer-matrix. Workers might be exposed during filling. During the polymerization process (done in a closed systems exposure is expected to be very low. Exposure of the general population/consumers is not expected, therefore only worker exposure will be taken into account.
The respiratory route is considered irrelevant for Cargill BP-A based on molecular weight and the very low vapour pressure.
Based on these considerations, it is concluded that correction of dose descriptors is not necessary to do route-to route extrapolation from the oral to the dermal route. In derivation of the DNELs, uncertainties in the extrapolation of experimental data to the human exposure situation (variability and uncertainty) will be taken into account.
In order to correct for the different units used to express the oral and dermal DNELS, the following approach is taken:
Based on an average bodyweight of 70 kg and an exposed area during filling (worst case approach) of 420 cm2 (one side of the hands), the DNEL will be corrected.
For acute toxicity no DNELs are derived based on the absence of hazards found in the acute toxicity tests and absence of high peak-exposures to Cargill BP-A. Based on the data it is expected that the long-term DNELs are sufficient to protect workers.
In order to derive the DNELs for long-term exposure in workers (long-term dermal DNEL) based on the 2-year feeding study in rats with ESBO, the following assessment factors are applied:
3 for
extrapolation from LOAEL to NOAEL
4 for
differences in metabolic rates
2.5 for other
interspecies differences
5 for
intraspecies differences (rat versus human worker)
1 for
differences in exposure duration
1 for
uncertainties in the dose-response relation
2 for
uncertainty of the data-base
All factors are default assessment factors. Only for the confidence in the data-base a worst case factor of 2 was chosen, because actual starting hazard data were not on Cargill BP-A, but on the surrogate compound ESBO. Based on the bridging studies available, no reason is available to expect that this factor should be higher.
The overall assessment factor is 300. This will lead to a DNEL of 0.83 mg/kg bw.
When a long-term dermal or oral DNEL is derived based on the developmental/fertility studies in the rat with ESBO, the following assessment factors are applied:
4 for
differences in metabolic rates
2.5 for other
interspecies differences
10 for
intraspecies differences (rat versus human)
1 for
differences in exposure duration
1 for
uncertainties in the dose-response relation
2 for
uncertainty of the data-base
All factors are default assessment factors. In a worst case approach the assessment factor for intra-species differences is set at 10, because the working population, due to age, might be more sensitive for any effects on the reproductive system. In addition, again for the confidence in the data-base a worst case factor of 2 was chosen, because actual starting hazard data were not on Cargill BP-A, but on the surrogate compound ESBO. Based on the bridging studies available, no reason is available to expect that this factor should be higher.
The overall assessment factor is 200. This will lead to a DNEL of 50 mg/kg bw.
Conclusion
In a worst case approach, the long-term dermal DNEL is based on the 2 year study in ratsGeneral Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
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