Registration Dossier
Registration Dossier
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EC number: 222-340-0 | CAS number: 3437-84-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.58 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 300 mg/kg/day from a 90-day repeat dose oral study with rats was used. (There were no findings of toxicological significance in animals of either sex).
The worst case assumption is as folows for route-to-route extrapolation:
Corrected inhal N(L)OAEC = oral N(L)OAELrat * 1/0.38 * 1 * 6.7/10
Corrected inhal N(L)OAEC = oral N(L)OAELrat * 1/sRVrat * ABSoral-rat/ABSinhhuman * 6.7/10
Assuming a ABSoral-rat/ABSinh-rat of (0.5/1) 0.5 a dose descriptor of 264.5 mg/m3 was derived as the starting point.
- AF for dose response relationship:
- 1
- Justification:
- based on REACH guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- based on REACH guidance for subacute to chronic
- Justification:
- not applicable when setting an inhalation DNEL based on REACH guidance
- 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
- AF for remaining uncertainties:
- 1
- Justification:
- based on REACH guidance
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:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 300 mg/kg/day from a 90-day repeat dose oral study with rats was used. (There were no findings of toxicological significance in animals of either sex).
Oral absorption rat – oral/dermal absorption human: Assume 25% absorption based on the physical-chemical properties in accordance with Endpoint Specific Guidance Chapter 8 and 7c (R.7.12).
- AF for dose response relationship:
- 1
- Justification:
- based on REACH guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- based on REACH guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- based on REACH guidance
- 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
- AF for remaining uncertainties:
- 1
- Justification:
- based on REACH guidance
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
DNELs have been calculated for non-sensitization repeat dose target effects.
Endpoint |
Bisisobutyryl Peroxide |
Phlegmatizer |
Mixture |
MW |
174.26 |
170.34 |
|
WS |
Based on WOE > 500 mg/L (stability data-see note below, EPIWEB) |
Insoluble (Supplier SDS); 4.86 ug/L (Disseminated Dossier); 43.57 ug/L (EPIWEB) |
|
Log Pow |
2.6 (measured OECD 117) |
6.96 (QSAR cal from disseminated dossier); 6.01 (EPIWEB) |
|
VP |
120 Pa (measured) |
126 Pa (measured) |
124 Pa (measured) |
Skin irritation |
|
Repeated exposure can defat skin and lead to irritation (supplier SDS) |
Corrosive (30 peroxide 70% solvent) |
|
|
|
|
|
NOTE: The pure peroxide is highly unstable and will completely decompose within 1/2 hour at ambient temperature. In a decomposition study using NMR it was estimated that the water solubility was 0.05% (500 mg/L) by extrapolation. |
|
|
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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