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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 32.9 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 468 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator), with starting point a NOAEL from sub-acute testing (OECD 422) involving exposures up to 62 days.
Corrected 8 hr inhalation NOAEC for workers: (including correction exposure conditions 5 d/week):
oral NOAELrat * 1/0.38 * 6.7/10. Additionally, a correction for differences between human and experimental exposure conditions of 1.4 is added (5 d/w versus experimental daily exposure). This results to a NOAEC workers of 2468 mg/m3
No factor 2 route extrapolation from oral to inhalation is applied: Reaction mass of N-[2-(2-hydroxyethoxy)ethyl]acetamide and glycerol is a liquid with a low vapour pressure of 0.028 Pa at 25 °C and high bp of 328°C. Exposure of relevant amounts by inhalation would only be possible in the form of dusts or aerosol, consisting of larger droplets depositing in upper airways with subsequently swallowing after mucociliary transportation to pharynx. This result to no principal difference in absorption compared to oral route.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator) - Already included in NOAEC calculation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties. Even though the DNEL is based on results from a sub-acute study up to 62 days, there is sufficient indication that extension of the duration of the study up to 90-days will not lead to different results. The currently applied AF of 3 for differences in duration can be regarded as a conservative approach.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Reaction mass of N-[2-(2-hydroxyethoxy)ethyl]acetamide and glycerol is a liquid with low vapour pressure of 0.028 Pa at 25 °C and high bp of 328°C. Its use is limited to skin care products and does not involve the forming of aerosols, particles or droplets of an inhalable size. Exposure to humans via the inhalation route are therefore unlikely to occur.
In view of the absence of toxicity indicated by testing via oral route, lack of cytotoxicity in in vitro toxicity testing, absence of irritating potential, and a long term systemic inhalation DNEL already above general dust limits, the occurrence of systemic effects following acute exposures is not conceivable.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 93.3 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Value:
- 28 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The default calculator has been applied: Starting point is an oral NOAEL from sub-acute testing (OECD 422) involving exposures up to 62 days. Profiling already indicate that the dermal absorption will be lower than oral, which for this small hydrophilic substance is considered to be 100%. The in vitro dermal absorption study showed that in general, less than 0.5% of the initial dose was absorbed over 24 hours (cumulative in receiver and in skin after 24 hour), and 3 to 3.5% was after 24 hours recovered from tapestrips. A conservative 5% is taken for dermal absorption.
Additionally, the 8 hr dermal NOAEL for workers was corrected for exposure conditions of 5 d/week.
This leads to a corrected dermal NOAEL for workers of 1000/5% * 7/5 = 28000 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties. Even though the DNEL is based on results from a sub-acute study up to 62 days, there is sufficient indication that extension of the duration of the study up to 90-days will not lead to different results. The currently applied AF of 3 for differences in duration can be regarded as a conservative approach.
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
No hazards are identified, and there are no use applications outside use in cosmetic products. Consequently, no exposure assessment is required. As the inhalation DNEL for workers is above the general dust limit, and Reaction mass of N-[2-(2-hydroxyethoxy)ethyl]acetamide and glycerol further is not irritating to skin or eyes, this in practice means that no specific risk reducing measures are required in industrial and professional situations.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
DNELs for general public are not required for uses in cosmetic products. Additionally, tonnage is below 1000 tpa, and no hazards at all have been identified for Reaction mass of N-[2-(2-hydroxyethoxy)ethyl]acetamide and glycerol.
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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