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Diss Factsheets
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EC number: 230-939-3 | CAS number: 7378-99-6
- 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:
- 0.176 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Derivation of an inhalation DNELsystemic long-term for a worker population
A) selection of relevant dose-descriptor(s) for the endpoint concerned
The lowest NOAEL was 30 mg/kg bw/day for developmental toxicity and this value may be taken as the definitive end point for the derivation of the DNEL for workers.
B) modification, when necessary, of relevant dose descriptor(s) per endpoint to the correct starting point (i.e., correct the unit of exposure) as described in Chapter R.8, Figure R. 8-3, conversion of an oral rat NOAEL into a corrected inhalatory NOAEC for workers.
NOAEL rat = 30 mg/kg bw/day
30 * 1/0.38 * 1/2(a)*6.7/10
30*2.63*0.5*0.67 = 26.43 mg/m3
NOAEC worker (8h) – 26.43 mg/m3
(a) Chapter R.8 page 19,In the absence of these data for both the starting route and the end route (the route to which the extrapolation is being made), worst case assumptions have to be made. Worst case in this context will be obtained assuming a limited absorption for the starting route, leading to a low (conservative) internal NOAEL. To secure a conservative external NOAEL a maximum absorption should there after be assumed for the end route, leading to a low external NOAEL. It is proposed, thus, in the absence of route-specific information on the starting route, to include a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route) in the case of oral-to inhalation extrapolation.
C) application, when necessary, of assessment factors to the correct starting point to obtain endpoint-specific DNEL(s) for the relevant exposure pattern (duration, frequency, route and exposed human population) (see Section R.8.4)
AF to be used
Interspecies (toxicokinetics(a) x toxicodynamics(b)) = not required
Intraspecies for workers(c)= 5
Duration of exposure(d)= 6
Dose-response relationship factor(e)= 5
Quality of whole database(f)= 1
Total AF = 150
Inhalation DNELsystemic long-termfor workers = 26.43/150 = 0.176 mg/m3
(a&b)Interspecies (toxicokinetics(a) x toxicodynamics(b)) = not required
(c) R.8.4.3.1. page 28, default assessment factor of 5 for workers
(d)R.8.4.3.1. page 29, NOAEL is from a sub-acute study
(e)R.8.4.3.1. page 133, the starting point for the DNEL is a NOAEL from an OECD 422 study with a reproduction toxicity endpoint
(f)R.8.4.3.1. page 31, 1 is the default factor to be applied to a good quality database taking into account data requirements for the tonnage band.
- AF for dose response relationship:
- 5
- Justification:
- R.8.4.3.1. page 133, the starting point for the DNEL is a NOAEL from an OECD 422 study with a reproduction toxicity endpoint
- AF for differences in duration of exposure:
- 6
- Justification:
- R.8.4.3.1. page 29, NOAEL is from a sub-acute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required according to the REACH Chapter R. 8. This is already taken into account when the oral NOAEL is converted into an inhalatory NOAEC (modificatoin of a starting point)
- AF for other interspecies differences:
- 5
- Justification:
- R.8.4.3.1. page 28, default assessment factor of 5 for workers
- AF for intraspecies differences:
- 1
- Justification:
- Not required according to the REACH Chapter R. 8. This is already taken into account when the oral NOAEL is converted into an inhalatory NOAEC (modificatoin of a starting point)
- AF for the quality of the whole database:
- 1
- Justification:
- R.8.4.3.1. page 31, 1 is the default factor to be applied to a good quality database taking into account data requirements for the tonnage band.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.176 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- DNEL extrapolated from long term DNEL
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:
- 0.02 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 500
- Dose descriptor starting point:
- NOAEL
- AF for dose response relationship:
- 5
- Justification:
- R.8.4.3.1. page 133, the starting point for the DNEL is a NOAEL from an OECD 422 study with a reproduction toxicity endpoint
- AF for differences in duration of exposure:
- 6
- Justification:
- NOAEL is from a sub-acute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R.8-3, allometric scaling for Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- R.8.4.3.1. page 24, Interspecies difference 2.5 ‘for remaining differences’
- AF for intraspecies differences:
- 5
- Justification:
- R.8.4.3.1. page 28, default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- R.8.4.3.1. page 31, 1 is the default factor to be applied to a good quality database taking into account data requirements for the tonnage band.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.02 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 500
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
DNELs for local effects have not been established for AD 1 as the DNEL for systemic effects and the risk mitigation measures identified in the exposure scenarios will also be protective of local effects exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNELs for the general population have not been derived.
AD 1 is imported into the EU and is a processing aid in a surface modification process. AD 1 is a VOC that is oxidized in an industrial oxidizer after use as a processing aid. It is not present in the finished ePTFE film.
Formulation is an industrial/professional task and therefore only worker DNELS for exposure by the dermal and inhalation routes will be derived. There will be no exposure to AD 1 for the general population.
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.