Registration Dossier

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