Registration Dossier
Registration Dossier
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EC number: 257-077-0 | CAS number: 51240-95-0
Toxicological Summary
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
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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