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EC number: 225-306-3 | CAS number: 4767-03-7
- 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:
- 14 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):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The oral NOAEL of 200 mg/kg bw/d from the rat developmental toxicity study is corrected for breathing rate (/0.38), activity (*0.67/10) and assuming that inhalation absorption is twice the level of oral absorption. The corrected inhalation NOAEC is therefore 176 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor. Effects seen at high dose levels in the developmental toxicity study are not considered to be of clear toxicological significance and do not constitute a severe developmental effect warranting the use of additional assessment factors.
- AF for differences in duration of exposure:
- 1
- Justification:
- Use of the NOAEL from the developmental toxicity study as a starting point provides an adequate margin of safety over the sub-chronic toxicity NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already taken into account in route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor (rat study)
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 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):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- As a worst case default assumption, dermal absorption is assumed to be the same as oral absorption. A corrected dermal NOAEL of 200 mg/kg bw/d is therefore derived.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor. Effects seen at high dose levels in the developmental toxicity study are not considered to be of clear toxicological significance and do not constitute a severe developmental effect warranting the use of additional assessment factors.
- AF for differences in duration of exposure:
- 1
- Justification:
- Use of the NOAEL from the developmental toxicity study as a starting point provides an adequate margin of safety over the sub-chronic toxicity NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor (rat study)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default assessment factor
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Endpoint selection
Bis-MPA is of low acute oral and dermal toxicity, is not a skin irritant or skin sensitiser, but is classified as an eye irritant. A report of accidental exposure to high levels of bis-MPA indicates that the substance may cause respiratory irritation, although this is not reported under normal conditions of use.
Two studies of repeated dose toxicity with bis-MPA are available. A NOAEL of 1000 mg/kg bw/d is reported for a 90-day rat toxicity study. In a rat developmental toxicity study, a maternal NOAEL of 1000 mg/kg bw/d is reported. A foetal NOAEL of 200 mg/kg bw/d is reported for this study based on slightly elevated incidences of early resorptions at dose levels of 500 and 1000 mg/kg bw/d. The magnitude of this effect is not large and values at 500 mg/kg bw/d (10%) and 1000 mg/kg bw/d (12%) are only slightly above the level seen in the concurrent controls (7%). The dose level of 200 mg/kg bw/d represents a clear NOAEL (7% early resorption incidence). The toxicological significance of the apparent increase in the proportion of early resorptions is unclear as findings at 500 and 1000 mg/kg bw/d are associated with (and may be secondary to) higher numbers of corpora lutea and implantations. Mean litter size was unaffected by treatment and was higher at 500 and 1000 mg/kg bw/d. Effects seen in this study at 500 and 1000 mg/kg bw/d are therefore not considered to be of clear toxicological significance and do not constitute a severe developmental effect warranting the use of additional assessment factors.
Based on the results of the 90-day and developmental toxicity studies, a starting point of 200 mg/kg bw/d (developmental toxicity NOAEL) is used for DNEL derivation.
Inhalation DNELs
Systemic Inhalation DNELs
The oral NOAEL of 200 mg/kg bw/d from the rat developmental toxicity study is corrected for breathing rate (/0.38), activity (*0.67) and assuming that inhalation absorption is twice the level of oral absorption. The corrected inhalation NOAEC is therefore 176 mg/m3.
Long-term systemic inhalation DNEL
Individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 12.5. Application of the overall assessment factor to the corrected inhalation NOAEC results in a DNEL of 14 mg/m3. An assessment factor is not used to take into account the relatively short duration of exposure in the developmental toxicity study as the 90-day study identifies a NOAEL of 1000 mg/kg bw/d. This gives an adequate margin of safety for potential chronic exposures.
Short-term systemic inhalation DNEL
Long-term systemic DNEL values are derived from the NOAEL for embryofoetal toxicity from the rat developmental toxicity study. Although, theoretically, effects could occur from a single exposure in a susceptible window, REACH Guidance (Chapter R8) notes that the conservative nature of the methodology used to derive the long-term DNEL should be sufficient to ensure that adverse effects do not occur following high short-term exposures, which should not result in the daily DNEL value being exceeded. A separate DNEL for acute/short-term exposure is therefore not derived. There is no indication of short-term or acute toxicity from other studies and the substance is not classified for acute toxicity.
Local Inhalation DNELs
Local long-term and short-term inhalation DNEL values are not derived, in the absence of suitable dose-reponse data. Respiratory irritation is not seen under normal conditions of use but is reported following a single accidental high exposure.
Dermal DNELs
Systemic Dermal DNELs
As a worst case default assumption, dermal absorption is assumed to be the same as oral absorption. A corrected dermal NOAEL of 200 mg/kg bw/d is therefore derived. Derivation of a short-term systemic DNEL is required as the developmental toxicity effects may theoretically result from an acute exposure.
Long-term systemic dermal DNEL
Individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 50. Application of the overall assessment factor to the corrected dermal NOAEL results in a DNEL of 4 mg/kg bw/d. An assessment factor is not used to take into account the relatively short duration of exposure in the developmental toxicity study as the 90-day study identifies a NOAEL of 1000 mg/kg bw/d. This gives an adequate margin of safety for potential chronic exposures.
Short-term systemic dermal DNEL
Long-term systemic DNEL values are derived from the NOAEL for embryofoetal toxicity from the rat developmental toxicity study. Although, theoretically, effects could occur from a single exposure in a susceptible window, REACH Guidance (Chapter R8) notes that the conservative nature of the methodology used to derive the long-term DNEL should be sufficient to ensure that adverse effects do not occur following high short-term exposures, which should not result in the daily DNEL value being exceeded. A separate DNEL for acute/short-term exposure is therefore not derived. There is no indication of short-term or acute toxicity from other studies and the substance is not classified for acute toxicity.
Local Dermal DNELs
Local long-term and short-term dermal DNEL values are not derived, in the absence of an identified hazard. The substance is not a skin irritant or skin sensitiser.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The oral NOAEL of 200 mg/kg bw/d from the rat developmental toxicity study is corrected for breathing rate (/1.15) and assuming that inhalation absorption is twice the level of oral absorption. The corrected inhalation NOAEC is therefore 87 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor. Effects seen at high dose levels in the developmental toxicity study are not considered to be of clear toxicological significance and do not constitute a severe developmental effect warranting the use of additional assessment factors.
- AF for differences in duration of exposure:
- 1
- Justification:
- Use of the NOAEL from the developmental toxicity study as a starting point provides an adequate margin of safety over the sub-chronic toxicity NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already taken into account
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- As a worst case default assumption, dermal absorption is assumed to be the same as oral absorption. A corrected dermal NOAEL of 200 mg/kg bw/d is therefore derived.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor. Effects seen at high dose levels in the developmental toxicity study are not considered to be of clear toxicological significance and do not constitute a severe developmental effect warranting the use of additional assessment factors.
- AF for differences in duration of exposure:
- 1
- Justification:
- Use of the NOAEL from the developmental toxicity study as a starting point provides an adequate margin of safety over the sub-chronic toxicity NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor (rat study)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default assessment factor
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:
- DNEL (Derived No Effect Level)
- Value:
- 2 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not required; the starting point is derived from an oral study
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor. Effects seen at high dose levels in the developmental toxicity study are not considered to be of clear toxicological significance and do not constitute a severe developmental effect warranting the use of additional assessment factors.
- AF for differences in duration of exposure:
- 1
- Justification:
- Use of the NOAEL from the developmental toxicity study as a starting point provides an adequate margin of safety over the sub-chronic toxicity NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor (rat study)
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Endpoint selection
Bis-MPA is of low acute oral and dermal toxicity, is not a skin irritant or skin sensitiser, but is classified as an eye irritant. A report of accidental exposure to high levels of bis-MPA indicates that the substance may cause respiratory irritation, although this would not be predicted to occur in the general population.
Two studies of repeated dose toxicity with bis-MPA are available. A NOAEL of 1000 mg/kg bw/d is reported for a 90-day rat toxicity study. In a rat developmental toxicity study, a maternal NOAEL of 1000 mg/kg bw/d is reported. A foetal NOAEL of 200 mg/kg bw/d is reported for this study based on slightly elevated incidences of early resorptions at dose levels of 500 and 1000 mg/kg bw/d. The magnitude of this effect is not large and values at 500 mg/kg bw/d (10%) and 1000 mg/kg bw/d (12%) are only slightly above the level seen in the concurrent controls (7%). The dose level of 200 mg/kg bw/d represents a clear NOAEL (7% early resorption incidence). The toxicological significance of the apparent increase in the proportion of early resorptions is unclear as findings at 500 and 1000 mg/kg bw/d are associated with (and may be secondary to) higher numbers of corpora lutea and implantations. Mean litter size was unaffected by treatment and was higher at 500 and 1000 mg/kg bw/d. Effects seen in this study at 500 and 1000 mg/kg bw/d are therefore not considered to be of clear toxicological significance and do not constitute a severe developmental effect warranting the use of additional assessment factors.
Based on the results of the 90-day and developmental toxicity studies, a starting point of 200 mg/kg bw/d (developmental toxicity NOAEL) is used for DNEL derivation.
Inhalation DNELs
Systemic Inhalation DNELs
The oral NOAEL of 200 mg/kg bw/d from the rat developmental toxicity study is corrected for breathing rate (/1.15) and assuming that inhalation absorption is twice the level of oral absorption. The corrected inhalation NOAEC is therefore 87 mg/m3.
Long-term systemic inhalation DNEL
Individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 25. Application of the overall assessment factor to the corrected inhalation NOAEC results in a DNEL of 3.5 mg/m3. An assessment factor is not used to take into account the relatively short duration of exposure in the developmental toxicity study as the 90-day study identifies a NOAEL of 1000 mg/kg bw/d. This gives an adequate margin of safety for potential chronic exposures.
Short-term systemic inhalation DNEL
Long-term systemic DNEL values are derived from the NOAEL for embryofoetal toxicity from the rat developmental toxicity study. Although, theoretically, effects could occur from a single exposure in a susceptible window, REACH Guidance (Chapter R8) notes that the conservative nature of the methodology used to derive the long-term DNEL should be sufficient to ensure that adverse effects do not occur following high short-term exposures, which should not result in the daily DNEL value being exceeded. A separate DNEL for acute/short-term exposure is therefore not derived. There is no indication of short-term or acute toxicity from other studies and the substance is not classified for acute toxicity.
Local Inhalation DNELs
Local long-term and short-term inhalation DNEL values are not derived, in the absence of suitable dose-reponse data. Respiratory irritation is not seen under normal conditions of use, but is reported following a single accidental high exposure in an industrial situation.
Dermal DNELs
Systemic Dermal DNELs
As a worst case default assumption, dermal absorption is assumed to be the same as oral absorption. A corrected dermal NOAEL of 200 mg/kg bw/d is therefore derived.
Long-term systemic dermal DNEL
Individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 100. Application of the overall assessment factor to the corrected dermal NOAEL results in a DNEL of 2 mg/kg bw/d. An assessment factor is not used to take into account the relatively short duration of exposure in the developmental toxicity study as the 90-day study identifies a NOAEL of 1000 mg/kg bw/d. This gives an adequate margin of safety for potential chronic exposures.
Short-term systemic dermal DNEL
Long-term systemic DNEL values are derived from the NOAEL for embryofoetal toxicity from the rat developmental toxicity study. Although, theoretically, effects could occur from a single exposure in a susceptible window, REACH Guidance (Chapter R8) notes that the conservative nature of the methodology used to derive the long-term DNEL should be sufficient to ensure that adverse effects do not occur following high short-term exposures, which should not result in the daily DNEL value being exceeded. A separate DNEL for acute/short-term exposure is therefore not derived. There is no indication of short-term or acute toxicity from other studies and the substance is not classified for acute toxicity.
Local Dermal DNELs
Local long-term and short-term dermal DNEL values are not derived, in the absence of an identified hazard. The substance is not a skin irritant or skin sensitiser.
Oral DNELs
Systemic Oral DNELs
Correction of the starting point is not required.
Long-term systemic oral DNEL
Individual assessment factors of 1 (for dose-response relationship), 1 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 100. Application of the overall assessment factor to the oral NOAEL results in a DNEL of 2 mg/kg bw/d. An assessment factor is not used to take into account the relatively short duration of exposure in the developmental toxicity study as the 90-day study identifies a NOAEL of 1000 mg/kg bw/d. This gives an adequate margin of safety for potential chronic exposures.
Short-term systemic oral DNEL
Long-term systemic DNEL values are derived from the NOAEL for embryofoetal toxicity from the rat developmental toxicity study. Although, theoretically, effects could occur from a single exposure in a susceptible window, REACH Guidance (Chapter R8) notes that the conservative nature of the methodology used to derive the long-term DNEL should be sufficient to ensure that adverse effects do not occur following high short-term exposures, which should not result in the daily DNEL value being exceeded. A separate DNEL for acute/short-term exposure is therefore not derived. There is no indication of short-term or acute toxicity from other studies and the substance is not classified for acute toxicity.
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.

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