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EC number: 500-014-1 | CAS number: 9004-95-9 1 - 2.5 moles ethoxylated
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance with modifications
- Overall assessment factor (AF):
- 50
- 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) for local effects of 300 mg/kg bw/day as determined in an oral combined repeated dose toxicity study with the reproduction / developmental toxicity screening test in the rat. For a discussion on using the local NOAEL to calculate systemic DNELs, please refer to the section 'Additional information - workers' below. 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:
- 4
- Justification:
- ECHA default assessment factor (AF) for extrapolation subchronic (90-day) to chronic: 2; ECHA default AF for extrapolation subacute (28-day) to chronic: 6
Dosing duration in OECD 422 study used as basis for DNEL calculation: Males: 29 days; Females that delivered: 50 - 64 days; Females that failed to deliver: 42 -43 days.
Since most of the test animals were dosed for > 50 days (females that delivered), scaling of the AF for differences in exposure duration is justified.
Scaled AF: (50/28) x 2 = 1.8 x 2 = 3.6. Therefore, an AF of 4 is considered conservative enough to reflect the acutal dosing situation in the OECD 422 study used as basis for the DNEL calculation. - 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:
- 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:
- 105 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance with modifications
- Overall assessment factor (AF):
- 200
- 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 for local effects of 300 mg/kg bw/day as determined in an oral combined repeated dose toxicity study with the reproduction / developmental toxicity screening test in the rat. For a discussion on using the local NOAEL to calculate systemic DNELs, please refer to the section 'Additional information - workers' below. 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:
- 4
- Justification:
- ECHA default assessment factor (AF) for extrapolation subchronic (90-day) to chronic: 2; ECHA default AF for extrapolation subacute (28-day) to chronic: 6
Dosing duration in OECD 422 study used as basis for DNEL calculation: Males: 29 days; Females that delivered: 50 - 64 days; Females that failed to deliver: 42 -43 days.
Since most of the test animals were dosed for > 50 days (females that delivered), scaling of the AF for differences in exposure duration is justified.
Scaled AF: (50/28) x 2 = 1.8 x 2 = 3.6. Therefore, an AF of 4 is considered conservative enough to reflect the acutal dosing situation in the OECD 422 study used as basis for the DNEL calculation. - 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:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
In the oral short-term repeated dose toxicity study with the reproduction / developmental toxicity screening test in the rat available for the substance, no adverse systemic effects have been observed and the No-Observed-Adverse-Effect-Level (NOAEL) for systemic effects was set at the high-dose level of 1000 mg/kg bw/day. In addition to the systemic NOAEL, a NOAEL for local effects was established at 300 mg/kg bw/day based on adverse histopathological changes in the stomach of test animals occurring in the mid-dose group. Therefore, it would be more meaningful to calculate a local instead of a systemic DNEL for long-term exposure.
ECHA Guidance on information requirements and chemical safety assessment, Chapter R8 states that for 'DNELs covering local inhalation and local dermal effects, route-specific data need to be available. (...) If no adequate experimental effect data are available on the relevant route of exposure for the population under consideration, route-to-route extrapolation might be an alternative, however only for systemic effects, not for local effects (e.g. irritation of the lungs following inhalation of a substance).'
Since no relevant data for local effects are available for the inhalation and dermal routes and route-to-route extrapolation is not suitable for local effects, no local DNELs for inhalation and dermal exposure can be calculated. However, to account for the local effects found after oral administration (as reflected by the reduced NOAEL of 300 mg/kg bw/day), systemic DNELs for long-term inhalation and dermal exposure are calculated based on the NOAEL for local effects. It is expected that exposure to the substance at doses ≤ 300 mg/kg bw/day does not lead to effects either locally or systemically. Therefore, a DNEL for long-term systemic exposure is considered protective enough also for local effects in the absence of a better option to take the local NOAEL into account.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.96 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance with modifications
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 196 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) for local effects of 300 mg/kg bw/day as determined in an oral combined repeated dose toxicity study with the reproduction / developmental toxicity screening test in the rat. For a discussion on using the local NOAEL to calculate systemic DNELs, please refer to the section 'Additional information - general population' below. Corrections for differences in respiratory volumes of laboratory animals and the general population (1/1.15 = 0.87) and for inhalative and oral bioavailability (0.75) were accounted for.
Corrected inhalatory NOAEC = NOAELoral, rat x (1/sRVrat) x (ABSoral, rat/ABSinhal., human)
sRV: Standard respiratory volume
ABS: Absorption rate (oral absorption is assumed to be 75% of inhalation absorption as default)
Corrected inhalatory NOAEC = 300 x 0.87 x 0.75 = 196 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:
- 4
- Justification:
- ECHA default assessment factor (AF) for extrapolation subchronic (90-day) to chronic: 2; ECHA default AF for extrapolation subacute (28-day) to chronic: 6
Dosing duration in OECD 422 study used as basis for DNEL calculation: Males: 29 days; Females that delivered: 50 - 64 days; Females that failed to deliver: 42 -43 days.
Since most of the test animals were dosed for > 50 days (females that delivered), scaling of the AF for differences in exposure duration is justified.
Scaled AF: (50/28) x 2 = 1.8 x 2 = 3.6. Therefore, an AF of 4 is considered conservative enough to reflect the acutal dosing situation in the OECD 422 study used as basis for the DNEL calculation. - 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:
- 10
- Justification:
- Default (DNEL calculator), general population
- 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:
- 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:
- 37.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance with modifications
- Overall assessment factor (AF):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 000 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 for local effects of 300 mg/kg bw/day as determined in an oral combined repeated dose toxicity study with the reproduction / developmental toxicity screening test in the rat. For a discussion on using the local NOAEL to calculate systemic DNELs, please refer to the section 'Additional information - general population' below. A correction for dermal and oral bioavailability (50.0) was accounted for.
Corrected dermal NOAEL = NOAELoral, rat x (ABSoral, rat/ABSdermal, human)
ABS: Absorption rate (absorption rate in humans established to be 2%; correction of oral (rat) and dermal (human) bioavailability: 1/0.02 = 50.0)
Corrected dermal NOAEL = 300 x 50.0 = 15000 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:
- 4
- Justification:
- ECHA default assessment factor (AF) for extrapolation subchronic (90-day) to chronic: 2; ECHA default AF for extrapolation subacute (28-day) to chronic: 6
Dosing duration in OECD 422 study used as basis for DNEL calculation: Males: 29 days; Females that delivered: 50 - 64 days; Females that failed to deliver: 42 -43 days.
Since most of the test animals were dosed for > 50 days (females that delivered), scaling of the AF for differences in exposure duration is justified.
Scaled AF: (50/28) x 2 = 1.8 x 2 = 3.6. Therefore, an AF of 4 is considered conservative enough to reflect the acutal dosing situation in the OECD 422 study used as basis for the DNEL calculation. - 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:
- 10
- Justification:
- Default (DNEL calculator), general population
- 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:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance with modifications
- Overall assessment factor (AF):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation is required as the oral long-term DNEL for systemic effects is based on a No-Observed-Adverse-Effect-Level (NOAEL) for local effects of 300 mg/kg bw/day as determined in an oral combined repeated dose toxicity study with the reproduction / developmental toxicity screening test in the rat. For a discussion on using the local NOAEL to calculate systemic DNELs, please refer to the section 'Additional information - general population' below.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator), starting point is NOAEL or NOAEC
- AF for differences in duration of exposure:
- 4
- Justification:
- ECHA default assessment factor (AF) for extrapolation subchronic (90-day) to chronic: 2; ECHA default AF for extrapolation subacute (28-day) to chronic: 6
Dosing duration in OECD 422 study used as basis for DNEL calculation: Males: 29 days; Females that delivered: 50 - 64 days; Females that failed to deliver: 42 -43 days.
Since most of the test animals were dosed for > 50 days (females that delivered), scaling of the AF for differences in exposure duration is justified.
Scaled AF: (50/28) x 2 = 1.8 x 2 = 3.6. Therefore, an AF of 4 is considered conservative enough to reflect the acutal dosing situation in the OECD 422 study used as basis for the DNEL calculation. - 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:
- 10
- Justification:
- Default (DNEL calculator), general population
- 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
In the oral short-term repeated dose toxicity study with the reproduction / developmental toxicity screening test in the rat available for the substance, no adverse systemic effects have been observed and the No-Observed-Adverse-Effect-Level (NOAEL) for systemic effects was set at the high-dose level of 1000 mg/kg bw/day. In addition to the systemic NOAEL, a NOAEL for local effects was established at 300 mg/kg bw/day based on adverse histopathological changes in the stomach of test animals occurring in the mid-dose group. Therefore, it would be more meaningful to calculate a local instead of a systemic DNEL for long-term exposure.
ECHA Guidance on information requirements and chemical safety assessment, Chapter R8 states that for 'DNELs covering local inhalation and local dermal effects, route-specific data need to be available. (...) If no adequate experimental effect data are available on the relevant route of exposure for the population under consideration, route-to-route extrapolation might be an alternative, however only for systemic effects, not for local effects (e.g. irritation of the lungs following inhalation of a substance).'
Since no relevant data for local effects are available for the inhalation and dermal routes and route-to-route extrapolation is not suitable for local effects, no local DNELs for inhalation and dermal exposure can be calculated. However, to account for the local effects found after oral administration (as reflected by the reduced NOAEL of 300 mg/kg bw/day), systemic DNELs for long-term inhalation and dermal exposure are calculated based on the NOAEL for local effects. It is expected that exposure to the substance at doses ≤ 300 mg/kg bw/day does not lead to effects either locally or systemically. Therefore, a DNEL for long-term systemic exposure is considered protective enough also for local effects in the absence of a better option to take the local NOAEL into account.
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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