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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-082-2 | CAS number: 32492-61-8 1 - 4.5 moles ethoxylated
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.88 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 440.79 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As the NOAEL was obtained on rats using the oral route, it must be corrected for an inhalation exposure of workers, taking into account that workers are considered to be working 8h/d, with inhalative volumes for 8h/d defined in the ECHA Guidance at 6.7m3 for base level activity and 10m3 for light activity.
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * ((ABS(oral-rat) / ABS(inhalation-human))) * (sRV(human) / wRV)
Where ABS = Absorption, sRV = standard Respiratory Volume, and wRV = worker Respiratory Volume. Absorptions by inhalation and oral route are not known, therefore in order to propose a conservative approach and as no actual absorption values are available, it was considered that oral absorption in the rat was 50% less effective than the human absorption by inhalation in accordance with ECHA Guidance.
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * ((ABS(oral-rat) / ABS(inhalation-human))) * (sRV(human) / wRV)
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * 0.5 * (sRV(human) / wRV)
Corrected NOAEC(inhalation) = 500 mg/kg bw * (1 / 0.38m3/kg) * 0.5 * (6.7m3 / 10m3)
Corrected NOAEC(inhalation) = 440.79 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.88 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor:
- NOAEC
- Value:
- 440.79 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
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:
- 1.67 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In accordance with the ECHA Guidance, in order to derive DNELs for the dermal route for systemic effects from a repeated-dose toxicity study by the oral route, a conversion must be made in order to take into account the differences between the routes.
Corrected NOAEL(systemic-dermal) = NOAEL(oral-rat) * ((ABS(oral-rat) / ABS(dermal-rat)))
Absorptions by dermal and oral routes are not known. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor should be introduced when performing oral-to-dermal extrapolation.
Corrected NOAEL(systemic-dermal) = NOAEL(oral-rat) * ((ABS(dermal-rat) / ABS(oral-human)))
Corrected NOAEL(systemic-dermal) = NOAEL(oral-rat) * 1
Corrected NOAEL(systemic-dermal) = 500 mg/kg/day * 1
Corrected NOAEL(systemic-dermal) = 500 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.04 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor:
- other: NOAEL = 2.81 mg/cm2
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The only effects observed were in a sub-acute oral toxicity / reproduction screening study with transient effects at 500 mg/kg. This was used as a NOAEL. Inhalation exposure is unlikely; figures estimated from oral study appear very high (using ECHA defaults). The dermal systemic DNEL generated using ECHA defaults appears low and provides a conservative assessment of the value.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.44 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217.39 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As the NOAEL was obtained on rats using the oral route, it must be corrected for an inhalation exposure of the general population, taking into account that the general population is considered as being exposed 24h/d. A sRV(rat) of 1.15m3/kg is used in order to consider this 24h/d exposure.
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * ((ABS(oral-rat) / ABS(inhalation-human)))
Where ABS = Absorption and sRV = standard Respiratory Volume. Absorptions by inhalation and oral route are not known, therefore in order to propose a conservative approach and as no actual absorption values are available, it was considered that oral absorption in the rat was 50% less effective than the human absorption by inhalation in accordance with ECHA Guidance.
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * ((ABS(oral-rat) / ABS(inhalation-human)))
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * 0.5
Corrected NOAEC(inhalation) = 500 mg/kg bw * (1 / 1.15m3/kg) * 0.5
Corrected NOAEC(inhalation) = 217.39 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.44 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor:
- NOAEC
- Value:
- 217.39 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In accordance with the ECHA Guidance, in order to derive DNELs for the dermal route for systemic effects from a repeated-dose toxicity study by the oral route, a conversion must be made in order to take into account the differences between the routes.
Corrected NOAEL(systemic-dermal) = NOAEL(oral-rat) * ((ABS(oral-rat) / ABS(dermal-rat)))
Absorptions by dermal and oral routes are not known. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor should be introduced when performing oral-to-dermal extrapolation.
Corrected NOAEL(systemic-dermal) = NOAEL(oral-rat) * ((ABS(dermal-rat) / ABS(oral-human)))
Corrected NOAEL(systemic-dermal) = NOAEL(oral-rat) * 1
Corrected NOAEL(systemic-dermal) = 500 mg/kg/day * 1
Corrected NOAEL(systemic-dermal) = 500 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.02 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor:
- other: NOAEL = 2.81 mg/cm2
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL derived from the subacute oral toxicity study by does not need to be modified for the purpose of DNEL calculation for the oral route
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The only effects observed were in a sub-acute oral toxicity / reproduction screening study with transient effects at 500 mg/kg. This was used as a NOAEL. Inhalation exposure is unlikely; figures estimated from oral study appear very high (using ECHA defaults). The dermal systemic DNEL generated using ECHA defaults appears low and provides a conservative assessment of the value.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
