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Diss Factsheets
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EC number: 202-307-7 | CAS number: 94-13-3
- 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:
- 88.2 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral * (1/0.38 m³/kg bw/d) * (ABSoral rat/ABSinh human) * (6.7 m³ (8h)/10 m³ (8h)) = 1000 mg/kg bw/d * (1/0.38 m³/kg bw/d) * (1/1) * 0.67 = 1763.2 mg/m³. ABSoral/rat=oral absorption rate in rats, ABSinh/human=inhalation absorption rate in humans. Based on the assessment of the toxicokinetic behavior of propylparaben, the absorption via the inhalation route is considered to be in the same range as via the oral route.
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance (no effect observed up to the limit dose of 1000 mg/kg bw)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance (subchronic to chronic exposure)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA Guidance (allometric scaling is not necessary for the inhalation route)
- AF for other interspecies differences:
- 1
- Justification:
- No additional interspecies default factor is necesarry (due to the substance characteristic no interspecies differences are to be expected. This is supported by a generally low toxicity profile. Additionally no species differences in the metabolism of the test substance were observed)
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidance (default factor for workers)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance (default value for good quality of database, also taking into account completeness and consistency)
- AF for remaining uncertainties:
- 2
- Justification:
- ECHA Guidance, route-to-route extrapolation (oral to inhalation)
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:
- 675.6 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 27 027 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term dermal toxicity available. Dermal absorption was taken with 3.7% acording to eSCCS Opinion on parabens (2010)
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance (no effect observed up to the limit dose of 1000 mg/kg bw)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance (subchronic to chronic exposure)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Guidance (allometric scaling rat to human)
- AF for other interspecies differences:
- 1
- Justification:
- No additional interspecies default factor is necesarry (due to the substance characteristic no interspecies differences are to be expected. This is supported by a generally low toxicity profile. Additionally no species differences in the metabolism of the test substance were observed)
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidance (default value for workers)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance (default value for good quality of database, also taking into account completeness and consistency)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Guidance, route-to-route extrapolation (oral to inhalation)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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
No DNELs have been derived for the short-term dermal and inhalation exposure of propylparaben for workers, as the assessment of hazard is considered to be sufficiently covered by deriving the respective DNELs for long-term exposure.
Since there are no inhalation and dermal repeated dose toxicity studies available as default, route-to-route extrapolation is performed using NOAEL of 1000 mg/kg body weight per day from a 90 day repeated dose oral toxicity study, which is identified as a key study for repeated dose toxicity. This study was performed according to OECD 408 (key study, 2018). 10 rats per sex and dose were treated with propylparaben at doses of 100, 300 and 1000 mg/kg bw via gavage for 90 days. During the study period, no mortality occurred and no significant effects on clinical signs, food consumption and body weight were observed. No adverse effects on haematology and clinical chemistry were noted throughout the study period. Based on the results of this study, the NOAEL for propylparaben was considered to be 1000 mg/kg bw/d for males and females. This NOAEL is used as starting pointfor the derivation of the worker DNEL "long-term inhalation exposure-systemic effecs".
For deriving the long-term worker DNEL for inhalation systemic effects according to the “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, 2012), the oral NOAEL has to be converted into an inhalatory NAEC: the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m³/kg for 8 h exposure). Additionally, it should be taken into account that during 8 hours light activity at work the respiratory rate becomes higher (10 m³/person) than standard (6.7 m³/person). Considering these differences, the corrected starting point is a NAEC of 1763.2 mg/m³.With regard to interspecies differences, allometric scalingconcerning concerning oral-to-inhalation extrapolation is not appropriate and no assessment factor is applied (ECHA guidance). Since the assessment is based on the outcome of a 90 day repeatd dose study, time extrapolation to chronic exposure conditions generally have to be be considered and the default factor of 2 (subchronic to chronis) is used. For itraspecies differences a an assessment factor of 5 as a default factor for workes is considered. Furthermore a conservative approach is taken and the default factor of 2 for remaining uncertainties using route-to-route extrapolation is applied. The resulting overall assessment factor is 20 (2x5x2) resulting in a DNEL "long-term inhalation exposure-systemic effects" of 88.2 mg/m3.
To convert the oral NOAEL [mg/kg bw/d] into a dermal NOAEL [mg/kg bw/d], the differences in absorption between routes, the differences in duration of exposure as well as differences in dermal absorption between rats and humans have to be accounted for (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health, ECHA, 2012). The dermal absorption of propylparaben lies at about 40% in human skin (Dal Pozzo and Pastori, 1996). According to the “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, 2012), a corrected dermal NOAEL was derived by taking into account the dermal absorption. With respect to the dermal DNEL derivation, the same ratinal apply like for the ihnalation route.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43.47 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):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.56 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term inhalation toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 2
- Justification:
- subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not necessary for the inhalation route
- AF for other interspecies differences:
- 1
- Justification:
- No default additional interspecies factor is used, since no species differences in the metabolism of the test substance were observed.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default value for good quality of database, also taking into account completeness and consistency.
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:
- DNEL (Derived No Effect Level)
- Value:
- 338 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):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 27 027 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term dermal toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- No default additional interspecies factor is used, since no species differences in the metabolism of the test substance were observed.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default value for good quality of database, also taking into account completeness and consistency.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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:
- 43.47 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):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 869.56 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- No default additional interspecies factor is used, since no species differences in the metabolism of the test substance were observed.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default value for good quality of database, also taking into account completeness and consistency.
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
No DNELs have been derived for the short-term oral, dermal and inhalation exposure of propylparaben for consumers, as it is considered that the assessment of hazard is sufficiently covered by deriving the respective DNELs for long-term exposure.
A 90 day repeated dose oral toxicity study, which is identified as a key study for repeated dose toxicit was used for deriving the DNEL. This study was performedaccording to OECD 408 (key study, 2018). 10 rats per sex and dose were treated with propylparaben at doses of 100, 300 and 1000 mg/kg bw via gavage for 90 days. During the study period, no mortality occurred and no significant effects on clinical signs, food consumption and body weight were observed. No adverse effects on haematology and clinical chemistry were noted throughout the study period. Based on the results of this study, the NOAEL for propylparaben was considered to be 1000 mg/kg bw/d for males and females. This NOAEL is used as starting pointfor the derivation of the worker DNEL "long-term inhalation exposure-systemic effecs".
This study was chosen as the starting point for deriving the long-term DNELs for the general population for inhalation and dermal systemic effects since there are no inhalation and dermal repeated dose toxicity studies available. The long-term DNEL for the general population oral systemic effects was derived directly from the oral repeated dose toxicity study.
For deriving the long-term consumer DNEL for inhalation systemic effects according to the “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, 2012), the oral NOAEL has to be converted into an inhalatory NAEC: the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m³/kg for 24 h exposure). Considering these differences, the corrected starting point is a NAEC of 869.56 mg/m³. Based on the assessment of the toxicokinetic behavior of propylparaben, the absorption via the inhalative route is considered to be in the same range as via the oral route.
To convert the oral NOAEL [mg/kg bw/d] into a dermal NOAEL [mg/kg bw/d], the differences in absorption between routes, the differences in duration of exposure as well as differences in dermal absorption between rats and humans have to be accounted for (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health, ECHA, 2012). The dermal absorption of propylparaben lies at about 40% in human skin (Dal Pozzo and Pastori, 1996). According to the “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, 2012), a corrected dermal NOAEL was derived by taking into account the dermal absorption.
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.
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