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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 611-390-2 | CAS number: 56467-43-7
- 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:
- 17.5 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):
- 34.3
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 523.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction for rat standard breathing volume, 8 hrs = 0.38 m3/kg (ECHA R.8, 2012)
Correction for activity driven differences of respiratory volumes in workers compared to workers = 10 m3/6.7 m3 (ECHA R.8, 2012)
Default AF for oral to inhalation extrapolation = 2 (ECHA R.8, 2012)
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 6
- Justification:
- AF 6 for extrapolation from sub-acute to chronic (ECHA R.8, 2012)
- AF for interspecies differences (allometric scaling):
- 5
- Justification:
- Default value for workers (ECHA R.8, 2012)
- AF for other interspecies differences:
- 1
- Justification:
- No other interspecies differences
- AF for intraspecies differences:
- 1
- Justification:
- No allometric scaling rat to humans as intraspecies adjustment is accounted for in relative breathing volumes (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study is of high quality, being rated K1. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining differences
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
AF for oral to dermal extrapolation = 1 (ECHA R.8, 2012).
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 6
- Justification:
- AF 6 for extrapolation from sub-acute to chronic (ECHA R.8, 2012)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans (ECHA R.8, 2012)
- AF for other interspecies differences:
- 1
- Justification:
- No other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study is of high quality, being rated K1. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Sytemic effects, long term
Calculation from the oral repeated dose/ repro screening study (OECD 422) study with BPMA in rats
DNEL inhal worker long-term
Description |
Value/ factor |
Remark |
|
Step 1) Relevant dose-descriptor |
NOAEL:600 mg/kg bw/d |
NOAEL determined by the highest dose tested in an OECD 422 study in rats by oral gavage |
|
Step 2) Modification of starting point |
0.38 m³/kg
6.7 m3/10 m3 |
Correction for rat standard breathing volume, 8 hrs (ECHA R.8, 2012) -Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (10 m3/6.7 m3) is required(ECHA R.8, 2012)
|
|
Route-to-Route extrapolation |
2 |
Oral to inhalation extrapolation (ECHA R.8, 2012) |
|
NAEC worker |
523.4 mg/m3 |
|
|
Step 3) Assessment factors |
|
|
|
Interspecies |
1 |
No allometric scaling rat to humans as intraspecies adjustment is accounted for in relative breathing volumes (ECHA R.8, 2012) |
|
Intraspecies |
5 |
Default value for workers (ECHA R.8, 2012) |
|
Exposure duration |
6 |
The NOAEL is based on a subacute study of approx. 50 d for the relevant sex (males). AF 6 for extrapolation from sub-acute to chronic (ECHA 2012) represents a conservative approach as this study period exceeds the duration of a normal subacute study almost by a factor of two and long term data from metabolites indicate a lower exposure duration effect as used here. |
|
Dose response |
1 |
The NOAEL is reliable. No adjustment is required. |
|
Quality of database |
1 |
The key study is of high quality, being rated K1. No adjustment is required. |
|
Remaining uncertainties |
1 |
No remaining differences |
|
DNEL |
|
||
Based upon a NOAEL of 600 mg/kg bw/d for male rats, for 50 d by the oral route. |
17.5 mg/m3 |
Using a total factor (POD modifier and AF) of 34.3 (/ 0.38 x 10/6.7 m³ x 2 x 1 x 5 x 6 x 1 x 1 x 1) a DNELlong-term, inhal, workerof 17.5 mg/m³ is derived. |
|
DNEL dermal worker long-term
Description |
Value/ factor |
Remark |
|
Step 1) Relevant dose-descriptor |
NOAEL:600 mg/kg bw/d |
NOAEL determined by the highest dose tested in an OECD 422 study in rats by oral gavage |
|
Step 2) Modification of starting point |
1 |
Oral to dermal extrapolation (ECHA R.8, 2012). |
|
NAEL worker |
600 mg/kg bw/d |
|
|
Step 3) Assessment factors |
|
|
|
Interspecies |
4 |
Allometric scaling rat to humans (ECHA R.8, 2012) |
|
Intraspecies |
5 |
Default value for workers (ECHA R.8, 2012)[KK5] |
|
Exposure duration |
6 |
The NOAEL is based on a subacute study of approx. 50 d for the relevant sex (males). AF 6 for extrapolation from sub-acute to chronic (ECHA 2012) represents a conservative approach as this study period exceeds a normal subacute study and long term data from metabolites indicate a lower exposure duration effect as used here. |
|
Dose response |
1 |
The NOAEL is reliable. No adjustment is required. |
|
Quality of database |
1 |
The key study is of high quality, being rated K1. No adjustment is required. |
|
Remaining uncertainties |
1 |
No remaining uncertainties |
|
DNEL |
|
||
Based upon a NOAEL of 600 mg/kg bw/d for male rats, for 50 d by the oral route. |
5.0 mg/kg bw/d |
Using a total factor (POD modifier and AF) of 120 (1 x 4 x 5 x 6 x 1 x 1) a DNELlong-term, dermal, workerof 5.0 mg/kg bw/d is derived. |
|
ylesterases, tricarboxylic acid cycle) makes a lower variability likely, hence the AF of3/5is sufficiently conservative. (ECETOC, 2010)
[KK5]In Absprache mit Harald 2017-12-06 auf Standardwerte (5/10) gesetzt, da Metabolismusdaten für BPMA fehlen)
Die Begründung für niedrigere ECETOC-Werte wäre gese dann wäre gewesen:
Known mode of action involving ubiquitous and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle) makes a lower variability likely, hence the AF of3/5is sufficiently conservative. (ECETOC, 2010)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.35 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):
- 138
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 199.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction for rat standard breathing volume, 24 hrs = 1.15 m3/kg (ECHA R.8, 2012)
Default AF for oral to inhalation extrapolation = 2 (ECHA R.8, 2012)
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 6
- Justification:
- AF 6 for extrapolation from sub-acute to chronic (ECHA R.8, 2012)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling rat to humans as intraspecies adjustment is accounted for in relative breathing volumes (ECHA R.8, 2012)
- AF for other interspecies differences:
- 1
- Justification:
- No other interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general poulation (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study is of high quality, being rated K1. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default AF for oral to dermal extrapolation (ECHA R.8, 2012).
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 6
- Justification:
- AF 6 for extrapolation from sub-acute to chronic (ECHA R.8, 2012)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans (ECHA R.8, 2012)
- AF for other interspecies differences:
- 1
- Justification:
- No other interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study is of high quality, being rated K1. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation required.
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 6
- Justification:
- AF 6 for extrapolation from sub-acute to chronic (ECHA R.8, 2012)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans (ECHA R.8, 2012)
- AF for other interspecies differences:
- 1
- Justification:
- No other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for workers (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study is of high quality, being rated K1. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Sytemic effects, long term
Calculation from the oral repeated dose/ repro screening study (OECD 422) study with BPMA in rats
DNEL inhal gen pop long-term
Description |
Value/ factor |
Remark |
|
Step 1) Relevant dose-descriptor |
NOAEL:600 mg/kg bw/d |
NOAEL determined by the highest dose tested in an OECD 422 study in rats by oral gavage |
|
Step 2) Modification of starting point |
1.15 m³/kg |
Correction for rat standard breathing volume, 24 hrs (ECHA R.8, 2012) |
|
Route-to-Route extrapolation |
2 |
Oral to inhalation extrapolation (ECHA R.8, 2012). |
|
NAEC general population |
199.8 mg/m3 |
|
|
Step 3) Assessment factors |
|
|
|
Interspecies |
1 |
No allometric scaling rat to humans as intraspecies adjustment is accounted for in relative breathing volumes (ECHA R.8, 2012) |
|
Intraspecies |
10 |
Default value for general population (ECHA R.8, 2012) |
|
Exposure duration |
6 |
The NOAEL is based on an subacute study of approx. 50 d for the relevant sex (males). AF 6 for extrapolation from sub-acute to chronic (ECHA 2012) represents a conservative approach as this study period exceeds a normal subacute study and long term data from metabolites indicate a lower exposure duration effect as used here. |
|
Dose response |
1 |
The NOAEL is reliable. No adjustment is required. |
|
Quality of database |
1 |
The key study is of high quality, being rated K1. No adjustment is required. |
|
Remaining uncertainties |
1 |
No remaining uncertainties |
|
DNEL |
|
||
Based upon a NOAEL of 600 mg/kg bw/d for male rats, for 50 d by the oral route. |
4.35 mg/m3 |
Using a total factor (POD modifier and AF) of 138 (/ 1.15 m³ x 2 x 1 x 10 x 6 x 1 x 1 x 1) a DNELlong-term,inhal, gen. pop.of 4.35 mg/m³ is derived. |
|
DNEL dermal general population long-term
Description |
Value/ factor |
Remark |
|
Step 1) Relevant dose-descriptor |
NOAEL:600 mg/kg bw/d |
NOAEL determined by the highest dose tested in an OECD 422 study in rats by oral gavage |
|
Step 2) Modification of starting point |
1 |
Oral to dermal extrapolation (ECHA R.8, 2012). |
|
NAEL general population |
600 mg/kg bw/d |
|
|
Step 3) Assessment factors |
|
|
|
Interspecies |
4 |
Allometric scaling rat to humans (ECHA R.8, 2012) |
|
Intraspecies |
10 |
Default value for general population (ECHA R.8, 2012) |
|
Exposure duration |
6 |
The NOAEL is based on an subacute study of approx. 50 d for the relevant sex (males). AF 6 for extrapolation from sub-acute to chronic (ECHA 2012) represents a conservative approach as this study period exceeds a normal subacute study and long term data from metabolites indicate a lower exposure duration effect as used here. |
|
Dose response |
1 |
The NOAEL is reliable. No adjustment is required. |
|
Quality of database |
1 |
The key study is of high quality, being rated K1. No adjustment is required. |
|
Remaining uncertainties |
1 |
No remaining uncertainties |
|
DNEL |
|
||
Based upon a NOAEL of 600 mg/kg bw/d for male rats, for 50 d by the oral route. |
2.5 mg/kg bw/d |
Using a total factor (POD modifier and AF) of 240 (1 x 4 x 10 x 6 x 1 x 1) a DNELlong-term,dermal, gen.pop.of 2.5 mg/kg bw/d is derived. |
|
DNEL oral general population long-term
Description |
Value/ factor |
Remark |
|
Step 1) Relevant dose-descriptor |
NOAEL:600 mg/kgbw/d |
NOAEL determined by the highest dose tested in an OECD 422 study in rats by oral gavage |
|
Step 2) Modification of starting point |
1 |
No route-to-route extrapolation required. |
|
NAEL general population |
600 mg/kg bw/d |
|
|
Step 3) Assessment factors |
|
|
|
Interspecies |
4 |
Allometric scaling rat to humans (ECHA R.8, 2012) |
|
Intraspecies |
10 |
Default value for general population (ECHA R.8, 2012) |
|
Exposure duration |
6 |
The NOAEL is based on an subacute study of approx. 50 d for the relevant sex (males). AF 6 for extrapolation from sub-acute to chronic (ECHA 2012) represents a conservative approach as this study period exceeds a normal subacute study and long term data from metabolites indicate a lower exposure duration effect as used here. |
|
Dose response |
1 |
The NOAEL is reliable. No adjustment is required. |
|
Quality of database |
1 |
The key study is of high quality, being rated K1. No adjustment is required. |
|
Remaining uncertainties |
1 |
No remaining uncertainties |
|
DNEL |
|
||
Based upon a NOAEL of 600 mg/kg bw/d for male rats, for 50 d by the oral route. |
2.5 mg/kg bw/d |
Using a total factor (POD modifier and AF) of 240 (1 x 4 x 10 x 6 x 1 x 1) a DNELlong-term,oral, gen.pop.of 2.5 mg/kg bw/d is derived. |
|
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.