Registration Dossier
Registration Dossier
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EC number: 220-713-2 | CAS number: 2873-97-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.3 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):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECinhal(mg/m3)= NOAELoral* 1/sRVrat*ABSoral-rat/ABSinh-human*sRVhuman/wRV
=100*1/0.38*1/1*6.7/10=176 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- covered by route to route extrapolation
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (90 day study) to chronic; ECHA guidance on Info Requirements R.8, 2012, page 24
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- NOAEL oral rat test; ECHA guidance on Info Requirements R.8, 2012, page 24
- AF for other interspecies differences:
- 1
- Justification:
- covered by route to route extrapolation
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC TR 110 Guidance on Assessment Factors to Derive a DNEL, October 2010, page 34
- AF for the quality of the whole database:
- 1
- Justification:
- 2 guideline studies (OECD 408 and OECD 414) reported an NOAEL of 100 mg/kg bw/day.
- AF for remaining uncertainties:
- 1
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 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):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
From toxicokinetic considerations it is expected that diacetone acrylamide is well absorbed for the oral and less for the dermal route.
Worst case assumption: ABS oral rat/ABS dermal human = 1
- AF for dose response relationship:
- 1
- Justification:
- covered by route to route extrapolation
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic (ECHA guidance on Info Requirements R.8, 20120
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance on Info Requirements R.8, 2012, page 24
- AF for other interspecies differences:
- 1
- Justification:
- covered by route to route extrapolation
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC TR 110 Guidance on Assessment Factors to Derive a DNEL, October 2010, page 34
- AF for the quality of the whole database:
- 1
- Justification:
- 2 guideline studies (OECD 408 and OECD 414) reported an NOAEL of 100 mg/kg bw/day.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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:
- low hazard (no threshold derived)
Additional information - workers
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
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