Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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