Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 939-592-9 | CAS number: 67254-71-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22.2 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:
- 555 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Basis for the calculation of the corrected inhalatory No-Observed-Adverse-Effect-Concentration (NOAEC) is a No-Observed-Adverse-Effect-Level (NOAEL) of 300 mg/kg bw/day as predicted for substances in the Alcohol Ethoxylates (AE) category. The prediction is based on subchronic (90-day) oral repeated dose toxicity studies in the rat available for several AE category member substances. For a detailed evaluation of the grouping and read-across approach in the AE category, please refer to the category justification attached to the category object. Corrections for differences in respiratory volumes of laboratory animals and workers (1/0.38 = 2.63), for the respiratory volume in light activity (6.7/10 = 0.67), for the frequency of exposure (7/5 = 1.4) as well as for inhalative and oral bioavailability (0.75) were accounted for.
Corrected inhalatory NOAEC = NOAELoral, rat x (1/sRVrat) x (sRVhuman/wRV) x (ABSoral, rat/ABSinhal., human) x (fexpo, rat/fexpo, worker)
sRV: Standard respiratory volume
wRV: Respiratory volume of workers (8 h)
ABS: Absorption rate (oral absorption is assumed to be 75% of inhalation absorption as default)
fexpo: Frequency of exposure (rat: 7 days/week; workers: 5 days/week)
Corrected inhalatory NOAEC = 300 x 2.63 x 0.67 x 0.75 x 1.4 = 555 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator), starting point is NOAEL or NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator), subchronic to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator), not relevant for inhalatory exposure as already considered in species-specific respiratory volumes
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator), workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator), high quality study used to calculate DNEL
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 210 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:
- 21 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Basis for the calculation of the corrected dermal No-Observed-Adverse-Effect-Level (NOAEL) is a NOAEL of 300 mg/kg bw/day as predicted for substances in the Alcohol Ethoxylates (AE) category. The prediction is based on subchronic (90-day) oral repeated dose toxicity studies in the rat available for several AE category member substances. For a detailed evaluation of the grouping and read-across approach in the AE category, please refer to the category justification attached to the category object. Corrections for dermal and oral bioavailability (50.0) and differences in the frequency of exposure (7/5 = 1.4) were accounted for.
Corrected dermal NOAEL = NOAELoral, rat x (ABSoral, rat/ABSdermal, human) x (fexpo, rat/fexpo, worker)
ABS: Absorption rate (absorption rate in humans established to be 2%; correction of oral (rat) and dermal (human) bioavailability: 1/0.02 = 50.0)
fexpo: Frequency of exposure (rat: 7 days/week; workers: 5 days/week)
Corrected dermal NOAEL = 300 x 50.0 x 1.4 = 21000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator), starting point is NOAEL or NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator), subchronc to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator), rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator), workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator), high quality study used to calculate DNEL
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
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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