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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DMEL (Derived Minimum Effect Level)
Value:
0.35 µg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10 000
Dose descriptor starting point:
BMDL10
Value:
0.717 mg/kg bw/day
Modified dose descriptor starting point:
BMCL10
Value:
3.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

The BMDL10 (BMD assumed to be 10% tumour rate) for all tumours in rats in a chronic study in drinking water (Dulak et al.) is 0.717 mg/kg/day. The following assessment factors were applied:

Corrected starting point for inhalation for oral study: 0.717 x (1/0.38) x (1/1) x (6.7/10) = 1.26 mg/m3

Workplace adjustments: 2.8 (working days/week: 7/5 x working weeks/year: 52/48 x working years: 75/40)

Corrected starting point for inhalation = 3.5 mg/m3

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:
DMEL (Derived Minimum Effect Level)
Value:
0.4 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10 000
Dose descriptor starting point:
BMDL10
Value:
0.717 mg/kg bw/day
Modified dose descriptor starting point:
BMDL10
Value:
4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The BMDL10 for all tumours in rats in a chronic study in drinking water (Dulak et al.) is 0.717 mg/kg/day. The following assessment factors were applied: Corrected starting point for dermal from oral study = 0.717×(1/0.5) = 1.43 mg/kg bw/day

Workplace adjustments: 2.8 ( = Working days/week: 7/5 x Working weeks/year: 52/48 x Working years: 75/40).

Corrected starting point for dermal exposure  = 4.0 mg/kg bw/day

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
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

The most sensitive non-chronic endpoint for acrylamide is dermal sensitisation. This is supported by numerous workplace observations. This effect has not been quantified. Inhalation exposure has been studied in animals no observed effects at 12 mg/m3 (Keeler, 1975)

The long-term dermal and inhalation DMELs were derived from the DMEL obtained from chronic oral exposure in a 2-year drinking-water study in rats (Friedman et al., 1995). The BMDL10 derived from this study is 0.45 mg/kg/day. The dermal and inhalation absorption factors applied were obtained from a study on humans for dermal absorption (Fennell et al., 2001) and in rats for inhalation absorption (Sumner et al, 2001).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The substance is an intermediate used under controlled conditions. It is only used as a monomer in the manufacture of polymers. Emmissions to air, soil and water are prevented. No direct or indirect exposure to the general population is to be expected.