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EC number: 700-427-9 | 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:
- 10.58 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- It was assumed that oral absorption rate is 50% of that of inhalation absorption.
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- based n 90 day toxicity (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- It was assumed that oral absorption rate is 50% of that of inhalation absorption.
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It is assumed that oral and dermal absorption rates are equal.
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- based n 90 day toxicity (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It is assumed that oral and dermal absorption rates are equal.
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.67 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 937.5
- Dose descriptor starting point:
- other: LOAEL
- AF for dose response relationship:
- 3
- Justification:
- based on LOAEL
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- data reliable
- AF for remaining uncertainties:
- 25
- Justification:
- vahicle or matrix effect (5) x different exposure conditions (5)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
DNEL - long term, worker
Inhalation systemic long term. Route-to-route extrapolation:
The calculations for the long term DNELs for workers are based on a 90 day oral feeding study performed in Fischer 344 rats. The NOAEL value in this study was found to be 300 mg/kg bw/d. This value was used as basis for DNEL calculation. Route-to-route extrapolation (oral to inhalative) was performed according to the ECHA Guidance Document on information requirements and chemical safety assessment Chapter R.8. It was assumed that oral absorption rate is 50% of that of inhalation absorption.
Starting point (worker, inhalation)= NOAEL oral*(1/sRVrat)*(sRVhuman/wRV)*(ABSoral-rat/ABSinh-human)= 300 mg/kg/d*(1/0.38m3/kg/d)*(6.7m3(8h)/10m3(8h))*0.5=264.47mg/m3
It was assumed that oral and dermal absorption rates are equal.
Starting point (worker,dermal)= 300 mg/kg/d
Assessment factors for DNEL derivations
Inhalation
Overall AF = 25
Dermal
Overall AF = 100
Taken above information
DNEL inhalation, long term, sytemic effects = 264.47/25=10.58 mg/m3
DNEL dermal, long term,systemic effects = 300/100=3 mg/kg bw/d
DNEL - short term, worker
Inhalation systemic effects acute.
DNELacute extrapolated from long term DNEL
Starting point (worker, inhalation, acute)=264.47 mg/m3
Assessment factors for DNEL derivations
Inhalation, worker,acute
Overall AF = 12.5
Dermal systemic effects acute.
DNEL acute extrapolated from long term DNEL
It was assumed that oral and dermal absorption rates are equal.
Starting point (worker,dermal)= 300mg/kg/d
Dermal
Overall AF = 50
Taken above information:
DNEL inhalation, short term, sytemic effects = 264.47/12.5=21.16 mg/m3
DNEL dermal, short term,systemic effects = 300/50=6 mg/kg bw/d
Worker DNEL LOCAL short-term dermal route
1.1) DNEL based on local effects (skin sensitisation)
The available dose descriptor is LOAEL of 4375μg/cm2obtained from the LLNA.
Assessment factors and DNEL calculation for worker-DNEL short-term dermal local effects
The relevant assessment factors were chosen in accordance with recommendations of the document Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (May 2008).
Uncertainties |
AF |
Justification |
|||
Default AFs |
|||||
Interspecies differences |
2.5 |
As the DNEL in case of Atlen SK is derived for local effects only, allometric scaling was not applied. For the remaining uncertainties in kinetic and in dynamic interspecies differences in spite of lack of data on the mechanism of toxicity (on the basis of available data it cannot be reliably concluded whether Atlen SK causes skin sensitization through simple destruction of membranes due to its physicochemical properties or through to a mechanism involving local metabolism) the default factor of 2.5 was applied. |
|||
Intraspecies differences |
5 |
For intraspecies differences standard approach was taken and default AFs were chosen i.e. in case of workers 5. |
|||
Exposure duration |
1 |
As DNEL is derived for acute local effect only, AF of 1 was applied for the effects of exposure duration. |
|||
Dose response |
3 |
As the starting point for derivation of DNEL was LOAEL for the dose-response relationship default AF of 3 was applied. |
|||
Skin sensitisation specific AFs |
|||||
Vehicle or matrix effect |
5 |
As exposure of humans to Atlen SK in matrices containing irritants cannot be excluded (taking into account chemicals used in the production process of Atlen SK as well as its use pattern) an AF of 5 was applied for the matrix effect. |
|||
Different exposure conditions |
5 |
Taking into account chemicals used in the production process of Atlen SK as well as its use pattern it can be expected that in at least some cases humans (particularly workers) will be exposed not only to Atlen SK but to other chemicals as well. Taking this into consideration an AF of 5 is applied for effects of different exposure conditions. |
|||
Overall assessment factor: 937.5 |
|||||
Endpoint specific DNEL: 4.67 µg/cm² |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.61 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- It was assumed that oral absorption rate is 50% of that of inhalation absorption.
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- based n 90 day toxicity (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.22 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- It was assumed that oral absorption rate is 50% of that of inhalation absorption.
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It was assumed that oral and dermal absorption rates are equal.
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- based n 90 day toxicity (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It was assumed that oral and dermal absorption rates are equal.
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.33 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 875
- Dose descriptor starting point:
- other: LOAEL
- AF for dose response relationship:
- 3
- Justification:
- based on LOAEL
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- data reliable
- AF for remaining uncertainties:
- 25
- Justification:
- vahicle or matrix effect (5) x different exposure conditions (5)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- based n 90 day toxicity (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- based on NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- differences in metabolic rate
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable data
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNEL - long term, general population
Inhalation systemic long term. Route-to-route extrapolation:
The calculations for the long term DNELs for workers are based on a 90 day oral feeding study performed in Fischer 344 rats. The NOAEL value in this study was found to be 1 mg/kg bw/d. This value was used as basis for DNEL calculation. Route-to-route extrapolation (oral to inhalative) was performed according to the ECHA Guidance Document on information requirements and chemical safety assessment Chapter R.8. It was assumed that oral absorption rate is 50% of that of inhalation absorption.
Starting point (general population, inhalation)= NOAEL oral*(1/1.15 m3/kg/d)*(ABSoral-rat/ABSinh-human)= 300mg/kg/d*(1/1.15m3/kg/d)*0.5=130.43 mg/m3
It was assumed that oral and dermal absorption rates are equal.
Starting point (general population,dermal)= 300 mg/kg/d
Assessment factors for DNEL derivations
Inhalation
Overall AF = 50
Dermal
Overall AF = 200
Taken above information
DNEL inhalation, long term, sytemic effects = 130.43/50=2.61 mg/m3
DNEL dermal, long term,systemic effects = 300/200=1.5 mg/kg bw/d
DNEL - short term, general population
Inhalation systemic effects acute.
DNELacute extrapolated from long term DNEL
Starting point (general population, inhalation, acute)=130.43 mg/m3
Assessment factors for DNEL derivations
Inhalation, general population,acute
Overall AF = 25
Dermal systemic effects acute.
DNELacute extrapolated from long term DNEL
It was assumed that oral and dermal absorption rates are equal.
Starting point (general population,dermal)= 300 mg/kg/d
Dermal
Overall AF = 100
Taken above information:
DNEL inhalation, short term, sytemic effects = 130.43/25=5.22 mg/m3
DNEL dermal, short term,systemic effects = 300/100=3 mg/kg bw/d
The DNELoral is the same as the DNEL dermal.
General population- Local DNEL short-term dermal route
2.1) DNEL based on local effects (skin sensitisation)
The available dose descriptor is LOAEL of 4375 μg/cm2obtained from the LLNA.
Assessment factors and DNEL calculation for general population-DNEL short-term dermal local effects
The relevant assessment factors were chosen in accordance with recommendations of the document Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (May 2008).
Uncertainties |
AF |
Justification |
Default AFs |
||
Interspecies differences |
2.5 |
As the DNEL in case of Atlen SK is derived for local effects only, allometric scaling was not applied. For the remaining uncertainties in kinetic and in dynamic interspecies differences in spite of lack of data on the Atlen SK mechanism of toxicity (on the basis of available data it cannot be reliably concluded whether Atlen SK causes skin sensitization through simple destruction of membranes due to its physicochemical properties or through to a mechanism involving local metabolism) the default factor of 2.5 was applied. |
Intraspecies differences |
10 |
For intraspecies differences standard approach was taken and default AFs were chosen i.e. 10 in case of general population. |
Exposure duration |
1 |
As DNEL is derived for acute local effect only, AF of 1 was applied for the effects of exposure duration. |
Dose response |
3 |
As the starting point for derivation of DNEL was LOAEL for the dose-response relationship default AF of 3 was applied. |
Skin sensitisation specific AFs |
||
Vehicle or matrix effect |
5 |
As exposure of humans to Atlen SK in matrices containing irritants cannot be excluded (taking into account chemicals used in the production process ofas well as its use pattern) an AF of 5 was applied for the matrix effect. |
Different exposure conditions |
5 |
Taking into account chemicals used in the production process of Atlen SK as well as its use pattern it can be expected that in at least some cases humans (particularly workers) will be exposed not only tobut to other chemicals as well. Taking this into consideration an AF of 5 is applied for effects of different exposure conditions |
Overall assessment factor: 1875 |
||
Endpoint specific DNEL: 2.33 µg/cm² |
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.