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Registration Dossier
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EC number: 429-320-2 | CAS number: 24748-23-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 44 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 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 50/100 = 0.5 based on phys-chem properties and Endpoint Specific Guidance chapters 8 and 7c (R.7.12) Corrected NOAEC = 50 mg/kg/day x (1/0.38 m3/kg/day) x (0.5) x 6.7 m3/10m3 = 44 mg/m3. Applying the remaining assessment factors of 25, the long-term systemic inhalation DNEL = 1.8 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- REACH Guidance
- Justification:
- REACH Guidance not applicable when setting an inhalatin DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal absorption was estimated to be 20% of oral.
- 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:
- medium hazard (no threshold derived)
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:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
MW |
Water Solubility |
Log P |
Vapor Pressure |
Surface Tension |
Systemic Toxicity |
264 |
13.1 mg/L (slightly soluble) |
4.84 |
4.1 Pa (0.0041 KPa) |
Log10 Koc 3.16 |
Yes 90-day oral |
DNEL Discussion
1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl- CAS# 24748-23-0 is a cyclic peroxy ketone
Study: 90-day repeat dose oral
NOAEL: 50 mg/kg/day
Summary: Findings at 50 mg/kg/day were of a minimal nature and did not indicate an adverse effect on
functional integrity. Based on the findings in the liver, kidneys and blood at 150 and 450
mg/kg/day,a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg/day
was established.
Worker Inhalation Systemic DNEL
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 50/100 = 0.5 based on phys-chem properties and Endpoint Specific Guidance chapters 8 and 7c (R.7.12)
Corrected NOAEC = 50 mg/kg/day x (1/0.38 m3/kg/day) x (0.5) x 6.7 m3/10m3
= 44 mg/m3
Applying remaining assessment factors in accordance with Endpoint Specific Guidance Chapter 8:
Correction for interspecies differences: 2.5
44 mg/m3/2.5 = 17.6 mg/m3
Correction for intraspecies differences: 5
17.6 mg/m3/5 = 3.52 mg/m3
Correction for duration between subchronic to chronic: 2
3.53 mg/m3/2 = 1.76 mg/m3
Correction for dose-response: 1
1.76 mg/m3/1 = 1.76 mg/m3
Correction for whole database: 1 due to quality of study
1.76 mg/m3/1 = 1.76 mg/m3
Total AF = 25
1.8 mg/m3DNEL inhalation-systemic-worker
Worker Dermal Systemic DNEL
Oral absorption rat – oral/dermal absorption human: Assume 20% absorption based on the phys-chem data in accordance with Endpoint Specific Guidance Chapter 8 and 7c (R.7.12).
50 mg/kg/day/0.2 = 250 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
250 mg/kg/day/10 = 25 mg/kg/day
Correction for intraspecies difference: 5
25 mg/kg/day/5 = 5 mg/kg/day
Correction for duration between sub-chronic to chronic: 2
5 mg/kg/day/2 = 2.5 mg/kg/day
Correction for dose-response: 1 due to NOAEL
2.5mg/kg/day/1 = 2.5
Correction for whole database: 1 due to quality of study
2.5 mg/kg/day/1 = 2.5 mg/kg/day
Total AF = 100
2.5 mg/kg/day DNEL dermal-worker-systemic
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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