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Diss Factsheets
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EC number: 201-607-5 | CAS number: 85-44-9
- 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
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:
- 49.4 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 617 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the inhalation route there is no animal study available. Therefore, oral rat data is used to calculate a corresponding air concentration for humans and a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a default factor of 2 is recommended according to chapter R.8.4.2 of the ECHA guidance on information requirements and chemical safety assessment, chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, November 2012). According to Figure R. 8-3 in the ECHA guidance on information requirements and chemical safety assessment, chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, November 2012) additional correction is needed for scaling issues: Corrected inhalatory NOAEC = oral NOAEL * 50%/100% * 1/0.38 m³ per kg and day * 6.7 m³/10 m³ * 1.4 (differences in experimental/human exposure conditions were considered with the factor 1.4 (7 days/week in animal study versus 5 days/week for workers in subchronic and chronic studies), based on the oral NOAEL of 500 mg/kg bw/day for systemic toxicity obtained in several subchronic feeding studies on rats and mice the starting point is calculated with 617 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Since the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- For differences in the experimental exposure duration (= chronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA guidance R.8 no specific assessment factor is considered.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in ECHA guidance R.8.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- AF for intraspecies differences:
- 5
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in workers is 5.
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 700 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the dermal route there is no animal study available. Therefore, oral rat data are used to calculate a corresponding dermal exposure dose for humans. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation (ECHA guidance R.8, chapter 8.4.2). Differences in experimental/human exposure conditions were considered with the factor 1.4 (7 days/week in animal study versus 5 days/week for workers), resulting in a corrected dermal NOAEL for workers of 500 mg/kg bw* 1.4 = 700 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- For differences in the experimental exposure duration (= chronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA guidance R.8 no assessment factor is considered.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to Table R.8-3 of ECHA guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- AF for intraspecies differences:
- 5
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in workers is 5.
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
According to the harmonized classification - Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) phthalic anhydride is classified with Acute Tox 4 (H302), Skin Irrit. 2 (H315), Eye Dam. 1 (H318), STOT SE 3 (H335), Skin Sens 1 (H317) and Resp. Sens 1 (H334).
Based on the available studies for skin sensitization a self-classification as Skin Sens. 1A ( H317: May cause an allergic skin reaction) is proposed by the registrant.
In chronic repeated oral feeding studies (105 weeks) severe chronic inflammatory, degenerative, or proliferative lesions frequently seen in aged rats and mice occurred with approximately equal frequency and severity in the dosed and control groups of animals. No tumors occurred in rats and mice of either sex at incidences that could be clearly related to the administration of the test chemical. Based on the reduced body-weight gain (<10 %) the NOAEL in this study was 500 mg/kg/day for rats. This NOAEL was taken forward for DNEL derivation.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the inhalation route there is no animal study available. Therefore, oral rat data is used to calculate a corresponding air concentration for humans and a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a ‘default factor of 2 is recommended according to chapter R.8.4.2 of ECHA guidance R.8. According to Figure R. 8-3 in ECHA guidance R.8 additional correction is needed for scaling issues: Corrected inhalatory NOAEC = oral NOAEL * 0.5 * 1/1.15 m³ per kg and day (based on the oral NOAEL of 500 mg/kg bw/day for systemic toxicity) the starting point is calculated with 217 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- For differences in the experimental exposure duration (= chronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA guidance R.8 a factor of 1 is considered.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in ECHA guidance R.8.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- AF for intraspecies differences:
- 10
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (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:
- 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the dermal route there is no animal study available. Therefore, oral rat data are used to calculate a corresponding dermal exposure dose for humans. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation (ECHA guidance R.8, chapter 8.4.2). Thus, no modification of the dose descriptor starting point is warranted.
- AF for dose response relationship:
- 1
- Justification:
- As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- For differences in the experimental exposure duration (= chronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA guidance R.8 a factor of 1 is considered.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to Table R.8-3 of ECHA guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
- AF for intraspecies differences:
- 10
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral data from the rat are used to decide on a corresponding oral dose for humans. Therefore a route-to-route extrapolation is not necessary and the NOAEL of 500 mg/kg bw/day from the rat study is used as starting point.
- AF for dose response relationship:
- 1
- Justification:
- As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor for dose response relationship is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- No difference in the experimental exposure duration (= chronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA guidance R.8.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to Table R.8-3 of ECHA guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8
- AF for intraspecies differences:
- 10
- Justification:
- According to chapter R.8.4.3.1 of ECHA guidance R.8 the default AF to be applied for intraspecies differences in the general population is 10.
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database as suggested by ECHA guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/kg bw/day
DNEL related information
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
According to the harmonized classification - Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) phthalic anhydride is classified with Acute Tox 4 (H302), Skin Irrit. 2 (H315), Eye Dam. 1 (H318), STOT SE 3 (H335), Skin Sens 1 (H317) and Resp. Sens 1 (H334).
Based on the available studies for skin sensitization a self-classification as Skin Sens. 1A ( H317: May cause an allergic skin reaction) is proposed by the registrant.
In chronic repeated oral feeding studies (105 weeks) severe chronic inflammatory, degenerative, or proliferative lesions frequently seen in aged rats and mice occurred with approximately equal frequency and severity in the dosed and control groups of animals. No tumors occurred in rats and mice of either sex at incidences that could be clearly related to the administration of the test chemical. Based on the reduced body-weight gain (<10 %) the NOAEL in this study was 500 mg/kg/day for rats. This NOAEL was taken forward for DNEL derivation.
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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