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EC number: 251-598-7 | CAS number: 33619-92-0
- 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:
- 3.29 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
- Dose descriptor starting point:
- NOAEC
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 246.84 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic inhalative effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14.
A NOAEL of 200 mg/kg bw /day was derived based on a sub-acute oral Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Screening Test in rats according to OECD Test Guideline 422. This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m³/kg/day, the absorption rates (based on the ECHA Guidance R.8 the inhalative absorption is considered to be higher by a factor of 2 than the oral absorption as worst-case assumption) and the standard respiratory volume in humans/ worker respiratory volume (6.7 m³ (8 h) / 10 m³ (8 h)) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEC corrected = 200 mg/kg bw/day * 1/0.38 m³/kg/day * 0.5 * (6.7 m³/10 m³) * 1.4 = 246.84 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
- Justification:
- high quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- 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:
- 0.93 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 280 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic dermal effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14.
A NOAEL of 200 mg/kg bw /day was derived based on a sub-acute oral Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Screening Test in rats according to OECD Test Guideline 422. This value was converted into the corrected dermal NOAEL taking into account the absorption rates (based on the physicochemical properties and toxicological profile, an oral absorption rate of 100 %, and a dermal absorption rate of 100 % are assumed as worst-case assumptions) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEL corrected = 200 mg/kg bw/day * 100/100 * 1.4 = 280 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
- Justification:
- high quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Consideration on the selected POD:
Two ‘Combined Repeated Dose Toxicity’ studies according to OECD Guideline 422 are available for IBP1-Na and EP1-Na. When comparing the NOAELs alone IBP1-Na appears to be a slightly more toxic than EP1-Na and thus represent a “worst case” source substance. However, the test conditions were not identical in these tests with regard to tester strain and vehicle used. In the OECD 422 study with IBP1-Na some slight liver effects (hypertrophy) and variations of some clinical chemistry parameter as well as slight reduction for the hind limb grip strength were noted at the highest test dose of 600 mg/kg bw/day. However, in the also available 90 day study according to OECD Guideline 408 those effects were not confirmed/seen after administration of IBP1-Na (at the same dose level), although the study implies a significant longer exposure and higher number of animals. Thus, the statistically significant “effects” noted in the OECD 422 study with the source substance are most likely accidental findings. Nevertheless, in order to follow a worst-case approach, the NOAEL of 200 mg/kg bw/d is selected for the derivation of the DNELs to be most protective.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 86.96 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic inhalative effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14. Details are given in the discussion. The DNEL for systemic inhalative effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14.
A NOAEL of 200 mg/kg bw /day was derived based on a sub-acute oral Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Screening Test in rats according to OECD Test Guideline 422. This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/1.15 m³/kg/day and the absorption rates (based on the ECHA Guidance R.8 the inhalative absorption is considered to be higher by a factor of 2 than the oral absorption as worst-case assumption).
NOAEC corrected = 200 mg/kg bw/day * 1/1.15 m³/kg/day * 0.5 = 86.96 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- high quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- 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:
- 0.33 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic dermal effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14.
A NOAEL of 200 mg/kg bw /day was derived based on a sub-acute oral Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Screening Test in rats according to OECD Test Guideline 422. No correction of this value is needed, as the absorption rates via dermal and oral routes are expected to be identical (100 % as worst-case for both routes).- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- high quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- 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:
- 0.33 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 200 mg/kg bw /day was derived based on a sub-acute oral Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Screening Test in rats according to OECD Test Guideline 422. No correction of this value is needed, as the oral absorption rates are considered to be identical between rats and humans.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- high quality of the database
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
Consideration on the selected POD:
Two ‘Combined Repeated Dose Toxicity’ studies according to OECD Guideline 422 are available for IBP1-Na and EP1-Na. When comparing the NOAELs alone IBP1-Na appears to be a slightly more toxic than EP1-Na and thus represent a “worst case” source substance. However, the test conditions were not identical in these tests with regard to tester strain and vehicle used. In the OECD 422 study with IBP1-Na some slight liver effects (hypertrophy) and variations of some clinical chemistry parameter as well as slight reduction for the hind limb grip strength were noted at the highest test dose of 600 mg/kg bw/day. However, in the also available 90 day study according to OECD Guideline 408 those effects were not confirmed/seen after administration of IBP1-Na (at the same dose level), although the study implies a significant longer exposure and higher number of animals. Thus, the statistically significant “effects” noted in the OECD 422 study with the source substance are most likely accidental findings. Nevertheless, in order to follow a worst-case approach, the NOAEL of 200 mg/kg bw/d is selected for the derivation of the DNELs to be most protective.
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.