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Diss Factsheets
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EC number: 219-143-7 | CAS number: 2372-21-6
- 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:
- 15.868 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 450 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 793.421 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No inhalation study data are available. The NOAEL of 450 mg/kg bw/day from an OECD 422 repeat dose oral gavage study in rats was used (males 42 days and females 56 days) as the starting point to calculate the DNEL. Assuming an oral/inhalation rate of absorption of 1.0, a dose descriptor of 15.868 mg/m3 was derived as the starting point. See discussion under "Additional information - Workers" for route to route extrapolation calculations.
- AF for dose response relationship:
- 1
- Justification:
- In accordance with REACH guidance 8.4.3.1
- AF for differences in duration of exposure:
- 4
- Justification:
- Sub-chronic to chronic; in accordance with Endpoint Specific Guidance Chapter 8
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- REACH guidance 8.4.3.1. AF included in route-to-route conversion
- AF for other interspecies differences:
- 2.5
- Justification:
- REACH guidance 8.4.3.1
- AF for intraspecies differences:
- 5
- Justification:
- REACH guidance 8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- Quality of study -based on REACH guidance
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:
- 4.5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 450 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 900 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 450 mg/kg/day from an OECD 422 repeat dose oral gavage study in rats was used (dosing: males 42 days and females 56 days) as the starting point to calculate the DNEL. Assumed 50% dermal absorption based on the physical-chemical properties (low molecular weight, Pow, and vapor pressure, and the water solubility of of 2.2 g/L) and in accordance with Endpoint Specific Guidance Chapters 8 and 7c (R.7.12). Therefore, a dose descriptor of 900 mg/kg bw/day was derived as the starting point. See discussion under "Additional information - Workers" for route to route extrapolation calculations.
- AF for dose response relationship:
- 1
- Justification:
- Based on reach guidance
- AF for differences in duration of exposure:
- 4
- Justification:
- Based on Reach guidance; sub-chronic to chronic exposure study
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- applying for allometric scaling 4 for rat x 2.5 for additional factors; based on Reach guidance
- AF for intraspecies differences:
- 5
- Justification:
- Based on Reach guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Based on Reach guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
O,O-tert-butyl isopropylmonoperoxycarbonate with a molecular weight of 176.21, has a low vapor pressure of 60 Pa at 22 degrees C, water solubility of 2.2 g/L at 20 degrees C, and log Kow of 2.5 at 30 degress C. It is a skin sensitizer (Cat 1b), and skin irritant (Cat 2).
DNEL dermal-systemic-worker;
The NOAEL of 450 mg/kg bw/day was selected from the OECD 422 repeat dose oral study in rats used for DNEL calculations on systemic effects of the substance. In that study, the substance was administered to rats at 50, 150, and 450 mg/kg bw/d by oral gavage.
Oral absorption rat – oral/dermal absorption human: Assume 50% dermal absorption based on the physical-chemical properties and in accordance with Endpoint Specific Guidance Chapter 8 and 7c (R.7.12). The substance being classified for skin irritation Cat. 2. The substance is a skin sensitizer, which is considered a systemic effect. Therefore, a qualitative risk assessment was done for acute dermal effects. However, DNELs were calculated for non-sensitizing systemic long term effects. For the DNEL covering local effects of inhalation and dermal routes of exposure, route-specific data need to be available (Guidance on information requirements and chemical safety assessment R 8.1.2.6). No such information is available.
Due to the low volatility and high water solubility, the respiratory absorption and oral absorption were considered equal. Guidance on requirements and chemical safety assessment Ch. R7c (page 159) states that "Vapors of very hydrophilic substances may be retained within the mucus. For absorption of deposited material similar criteria as for GI absorption apply."
There are no consumer uses of this substance. Human exposure, via the environment, is unlikely due to the instability of the peroxide.
DNEL inhalation-systemic-worker
Corrected inhalatoary NOAEC from oral NOAEL
Oral NOAEL x (1/sRVrat) x (ABSoral-rat/ABSinh-human) x (sRVhuman/wRV)
Assume ABSoral-rat/ABSinh-human is 100/100 = 1.0, based on phys-chem properties and Endpoint Specific Guidance chapters 8 and 7c (R.7.12)
[ABS: absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory Volume]
Corrected NOAEC= 450 mg/kg/day x (1/0.38 m3/kg/day) x (1.0) x 6.7m3/10m3 = 793.421 mg/m3
Applying remaining assessment factors in accordance with Endpoint Specific Guidance Chapter 8:
Correction for interspecies differences: 2.5
793.421 mg/m3/2.5 = 317.368 mg/m3
Correction for intraspecies differences: 5
317.368 mg/m3/5 = 63.474 mg/m3
Correction for duration between subacute (6-8 weeks) to chronic: 4
63.474 mg/m3/4 = 15.868 mg/m3
Correction for dose-response: 1
15.868 mg/m3/1 = 15.868 mg/m3
Correction for whole database: 1 due to quality of study
15.868 mg/m3/1 = 15.868 mg/m3
Total AF = 50
15.868 mg/m3, DNEL inhalation-systemic-worker
DNEL dermal-systemic-worker
Assume 50% dermal absorption based on the physical-chemical properties.
450 mg/kg/day/0.5 = 900 mg/kg/day = dermal dose descriptor
Applying assessment factors in accordance with Endpoint Specific Guidance Chapter 8:
Correction for interspecies differences (apply factor for allometric scaling 4 for rat x 2.5 for additional factors): 10
900 mg/kg/day/10 = 90 mg/kg/day
Correction for intraspecies difference: 5
90 mg/kg/day/5 = 18 mg/kg/day
Correction for duration between sub-chronic (6-8 weeks) to chronic: 4
18 mg/kg/day/4 = 4.5 mg/kg/day
Correction for dose-response: 1 due to NOAEL
4.5mg/kg/day/1 = 4.5
Correction for whole database: 1 due to quality of study
4.5 mg/kg/day/1 = 4.5 mg/kg/day
Total AF = 200
4.5mg/kg/day, DNEL dermal-worker-systemic
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
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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