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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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EC number: 253-781-7 | CAS number: 38103-06-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 0.2 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
100 mg/kg/day x (1/0.38 m3/kg/day) x 6.7 m3/10 m3 x (10/100 oral absorption in rats/inhalation absorption in humans) = 17.6 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- default value for subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
The same extent for dermal and oral absorption (i.e. 10%) has been set for risk assessment purposes
- AF for dose response relationship:
- 1
- Justification:
- starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- default value for subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- no hazard identified
Additional information - workers
Based on the available acute toxicity data (oral, dermal), BPA-DA is not expected to be an acute toxicant. In addition, based on available irritation and sensitization data, BPA-DA would not be considered an irritant or sensitizer. Therefore, derivation of DNEL long-term will be sufficient to control potential risks associated with short-term exposures.
Although the NOAEL from the 28 -day oral study was > 2750 mg/kg/day as no adverse effects were reported in the study, a lower NOAEL at 100 mg/kg/day for systemic toxicity was obtained in an OECD 421 study, mainly based on effects on body weight/body weight gain. This is also supported by results of pre-natal developmental toxicity studies in rats and rabbits, both conducted at the limit dose of 1000 mg/kg bw/day and both determining the NOAEL for maternal toxicity to be lower than 1000 mg/kg/day, again mainly based on effects on body weight/body weight gains. As a conservative estimate, the long-term DNELs for systemic toxicity are derived using the lowest NOAEL of 100 mg/kg/day.
Route-to-route extrapolation
Long-term systemic DNELs for workers are derived for the dermal and inhalation routes of exposure. However, the only repeat dose toxicity studies available for BPA-DA are on the oral route of exposure. Therefore, route-to-route extrapolation from the oral route to the dermal and inhalation routes is required.
Dermal DNEL starting dose
Both oral and dermal absorption are set at 10 %. The starting dose for setting the long-term dermal systemic DNEL is therefore 100 mg/kg/day.
Inhalation starting dose
The oral NOAEL needs to be converted to an inhalation NOAEL. The worst-case assumption is that absorption is limited for the starting (oral) route, and maximal for inhalation. Oral absorption is set at 10 % for risk assessment purposes and absorption via inhalation is set at 100 % although it is noted that the substance is too large for being inhaled or taken up by macrophages. The starting dose for setting the long-term systemic inhalation DNEL is therefore 100 mg/kg/day x (1/0.38 m³/kg/day) x 6.7 m³/10 m³ x (10/100 oral absorption in rats/inhalation absorption in humans) = 17.6 mg/m³.
Assessment factor for Interspecies
Per page 30 of ECHA Guidance R.8, interspecies assessment factor should include an allometric scaling (AS) factor plus an additional factor of 2.5. In the case of the rat, a factor 4 is recommended in the ECHA Guidance R.8. So the interspecies AF is equal to 4 x 2.5 = 10. Per page 68 of the ECHA Guidance R.8, an allometric scaling factor is not used when extrapolating from an oral NOAEL to an inhalation exposure. Therefore, for inhalation, only an interspecies factor of 2.5 is used.
Assessment factor for Intraspecies
Per page 33 -34 of ECHA Guidance R.8, intraspecies AF should be 5 for workers.
Assessment factor for duration differences
Per page 35 of ECHA Guidance R.8, the AF for extrapolation from a subacute toxicity study to a chronic is 6.
Assessment factor for issues related to dose response
No additional assessment factor is required since a NOAEL was used (i.e. assessment factor = 1).
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
The substance is used (and transported) as intermediate under strictly controlled conditions; no exposure to the general population will occur.
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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