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EC number: 407-950-9 | CAS number: 895-85-2 INTEROX-PMBP-70W; INTEROX-PMPB-70W
- 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:
- 23.49 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:
- 1 762 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 1000 mglkglday from a 28-day repeat dose oral study with rats was used. Assuming an oral/inhaiation rate of absorption of 1.0, a dose descriptor of 1762 mg/m3 was derived as the starting point. See discussion for route to route extrapolation calculation.
- AF for dose response relationship:
- 1
- Justification:
- Based on REACH guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Based on REACH guidance for subacute to chronic
- AF for other interspecies differences:
- 2.5
- Justification:
- 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:
- 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:
- 33.33 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 1000 mglkglday from a 28-day repeat dose oral study with rats was used. Oral absorption rat – oral/dermal absorption human: Assume 10% absorption based on the physical-chemical properties (poor water solubility, test substance is a paste, higher log Pow, and non-irritating to the skin) in accordance with Endpoint Specific Guidance Chapter 8 and 7c (R.7.12). Therefore, a dose descriptor of 10000 mg/kg/day was derived as the starting point. See discussion for route to route extrapolation calculation.
- AF for dose response relationship:
- 1
- Justification:
- Based on ECHA REACH guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Based on ECHA REACH guidance for subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Based on ECHA REACH guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Based on ECHA REACH guidance
- AF for intraspecies differences:
- 5
- Justification:
- Based on ECHA REACH guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Based on ECHA 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Phys-chem data considered for the calculation of DNEL for CAS 895-85-2;
Endpoint |
Peroxide |
MW |
270.28 g/mol, powder |
WS |
poorly soluble (0.043 mg/L) (measured, OECD 105) |
Log Pow |
4.7 (measured, OECD 117) |
VP |
0.0012 Pa at 25oC (calculated) |
Skin irritation |
Non-irritant |
Initial Dose Descriptor
The peroxide is a low molecular weight substance with poor water solubility (23 ug/L) and a relatively high log Pow value of 4.7. Any lipophilic compound may be taken up by micellar solubilization but this mechanism may be of particular importance for highly lipophilic compounds (log P > 4), particularly those that are poorly soluble in water (< 1 mg/L) that would otherwise be poorly absorbed.
In a 28-day oral gavage study with rats based on treatment-related findings that were either statistically or toxicologically insignificant in males and females treated up to 1000 mg/kg/day, a No-Observed-Adverse-Effect-Level (NOAEL) of 1000 mg/kg body weight/day of Di-(4 -Methylbenzoyl)-peroxid (INTEROX-PMBP) was established (Hoff, 1992). Minor histopathologic findings in cecum, liver and adrenal glands of some animals were concluded toxicologically insignificant. The presence of polyethylene glycol 400 (vehicle) in the oral gavage formulation could have slightly increased the test substance’s absorption from the digestive tract due greater chances of emulsification and digestion. Still, the results suggest the test substance was either poorly absorbed and/or efficiently metabolized/eliminated by the rats. Based on these considerations, the NOAEL for DNEL calculations was set at 1000 mg/kg/day.
Exposure to a repeated oral high dose is not expected under normal occupational settings and there are no consumer uses for this substance.
Inhalation: The estimated vapor pressure (0.0012 Pa at 25oC) of the test substance is low. Therefore, inhalation is not expected to be a major route of exposure. Because the low vapor pressure, particle size (>100 um), and poor water solubility, a factor of 1.0 is used for oral to inhalation conversion. Particles with aerodynamic diameters <100 um have the potential to be inspired (inhaled). Granulometry of the test item showed that practically no particles <100 um were present in the test item. Therefore, no systemic toxicity effects are expected (European commission, “Guidance Document on the Determination of Particle Size Distribution, Fiber Length, Diameter Distribution of Chemical Substances”, 2002).
For the DNEL covering local effects of inhalation, route-specific data need to be available (Guidance on information requirements and chemical safety assessment R 8.1.2.6). Human exposure, via the environment, is unlikely.
DNEL dermal-systemic-worker for CAS 895-85-2
The dose descriptor of 1000 mg/kg/day was selected from a 28-day repeat dose oral study in rats.
The LD50 for acute dermal toxicity in rats was > 2000 mg/kg b.w. The test item is neither an irritant to the rat skin nor a sensitizer to the guinea pig skin suggesting poor uptake or systemic effects. Based on the physical properties (low molecular weight; poor water solubility; log P = 4.7; low vapor pressure, 0.0012 Pa at 25 degrees C), the test substance is expected to have a relatively low dermal absorption rate.
Oral absorption rat – oral/dermal absorption human: Assume 10% absorption based on the physical-chemical properties in accordance with Endpoint Specific Guidance Chapter 8 and 7c (R.7.12).
DNEL dermal-systemic-worker
1000 mg/kg/day / 0.10 = 10000 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 = 10000 mg/kg/day/10 = 1000 mg/kg/day
Correction for intraspecies difference: 5
1000 mg/kg/day/5 = 200 mg/kg/day
Correction for duration between sub-acute to chronic: 6
200 mg/kg/day/6 = 33.33 mg/kg/day
Correction for dose-response: 1 due to NOAEL
33.33 mg/kg/day/1 = 33.33 mg/kg/day
Correction for whole database: 1 due to quality of study
33.33 mg/kg/day/1 = 33.33 mg/kg/day
Total AF = 300
33.33 mg/kg/day DNEL dermal-worker-systemic
DNEL inhalation-systemic-worker
The dose descriptor of 1000 mg/kg/day was selected from a 28-day repeat dose oral study in rats.
Assume ABSoral-rat/ABSinh-human is 100/100 = 1.0 based on phys-chem properties (not inhalable, based on particle size) and Endpoint Specific Guidance chapters 8 and 7c (R.7.12)
Corrected inhalatory NOAEC from oral NOAEL:
Oral NOAEL x (1/sRVrat) x (ABSoral-rat/ABSinh-human) x (sRVhuman/wRV)
[ABS: absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory Volume]
Corrected NOAEC = 1000 mg/kg/day x (1/0.38 m3/kg/day) x (1.0) x 6.7m3/10m3=1762 mg/m3= inhalation dose descriptor
Applying remaining assessment factors in accordance with Endpoint Specific Guidance Chapter 8:
Correction for interspecies differences: 2.5
1762 mg/m3/2.5 = 704.8 mg/m3
Correction for intraspecies difference: 5
704.8 mg/m3/5 = 140.96 mg/m3
Correction for duration between sub-acute to chronic: 6
140.96 mg/m3/6 = 23.49 mg/m3
Correction for dose-response: 1
23.49 mg/m3/1 = 23.49 mg/m3
Correction for whole database: 1 due to quality of study
23.49 mg/m3/1 = 23.49 mg/m3
Total AF = 75
23.49 mg/m3DNEL inhalation-systemic-worker
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
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