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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.5 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:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
87.1 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL of 50 mg/kg/day from an OECD443 repeat dose oral study with rats was used. Assuming an oral /inhalation absorption of 1.0 a dose descriptor


of 87.1 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 subchronic to chronic
AF for interspecies differences (allometric scaling):
1
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:
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:
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):
100
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL of 50 mg/kg/day from an OECD443 repeat dose oral study with rats was used. Oral/dermal absorption was assumed to be 10%. The dose


descriptor was therefore 500 mg/kg/day.

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 sub-chronic to chronic
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:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
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

Initial Dose Descriptor


The NOAEL used to calculate DNELs is 50 mg/kg/day (OECD 443 study).


 


DNEL dermal-systemic-worker


Based on the log Pow of 6.9, the peroxide is expected to stay partitioned in the phlegmatizer. Based on the log kow of 6.96, vapor pressure and water solubility, the phlegmatizer is not expected to penetrate the skin to a significant degree. Therefore, the peroxide will not be significantly absorbed via the skin.


































Endpoint



dihexadecyl peroxodicarbonate



MW



300.48



WS



33.6 µg/L



MP



< -28.0°C



Log Pow



> 6.5 (6.9 extrapolated)



VP



Peroxide in solvent < 0.24 Pa at25°C


Pure peroxide: 0.0001 -0.01 Pa at25°C



Skin irritation



Mild irritant (Cat 3)



 


Oral absorption rat – oral/dermal absorption human: Assume 10% absorption based on the data above in accordance with Endpoint Specific Guidance Chapter 8 and 7c (R.7.12).


 


NOAEL 50 mg/kg/day/0.1 = 500 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


Correction for intraspecies difference: 5


Correction for duration between sub-acute to chronic: 2


Correction for dose-response: 1 due to NOAEL


Correction for whole database: 1 due to quality of study


Total AF = 100


5 mg/kg/day DNEL dermal-worker-systemic


 


DNEL inhalation-systemic-worker


The vapor pressure of the pure peroxide was pure peroxide: 0.0001-0.01 Pa at 25°C. The vapor pressure of the solvent peroxide mixture is < 0.24 Pa at 25°C


Based on the low vapor pressure, inhalation is not expected to be a major route of exposure.


Corrected inhalatory NOAEC from oral NOAEL


Oral NOAEL x (1/sRVrat) x (ABSoral-rat/ABSinh-human) x (sRVhuman/wRV)


Assume ABSoral-rat/ABSinh-human is 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 = 50 mg/kg/day x (1/0.38 m3/kg/day) x (1.0) x 6.7 m3/10m3 = 87.1 mg/m3


Applying remaining assessment factors in accordance with Endpoint Specific Guidance Chapter 8:


Correction for interspecies differences: 2.5


Correction for intraspecies differences: 5


Correction for duration between subacute to chronic: 2


Correction for dose-response: 1


Correction for whole database: 1 due to quality of study


Total AF = 25


3.5 mg/m3 DNEL inhalation-systemic-worker


 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - General Population