Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.76 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Dose descriptor:
other: German MAK Value for n-Butyl Acrylate (2 ppm); converted to mg/m3 and adjusted for the difference in molecular weight
AF for dose response relationship:
1
Justification:
not required. See in Discussion for details.
AF for differences in duration of exposure:
1
Justification:
not required. See in Discussion for details.
AF for interspecies differences (allometric scaling):
1
Justification:
not required. See in Discussion for details.
AF for other interspecies differences:
1
Justification:
not required. See in Discussion for details.
AF for intraspecies differences:
1
Justification:
not required. See in Discussion for details.
AF for the quality of the whole database:
1
Justification:
not required. See in Discussion for details.
AF for remaining uncertainties:
1
Justification:
not required. See in Discussion for details.
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

N-hexyl acrylate acrylate is manufactured and processed within closed systems. The primary routes of industrial exposure to n-hexyl acrylate are skin contact and inhalation. In an industrial setting, ingestion is not an anticipated route of exposure.

 

The data on n-butyl acrylate, an analogue substance of n-hexyl acrylate, were used for the repeated studies. Dose-level selection for long-term studies was limited by severity of local effects on the upper respiratory tract, therefore long-term exposure systemic DNELs were not calculated. 

 

DNEL of n-butyl acrylate (long-term local effect by inhalation):

 

In 2000 the German MAK commission determined a scientific OEL for n-butyl acrylate of 2 ppm (11 mg/m3), which was confirmed as a German OEL by the regulatory authorities. The evaluation is based on the chronic inhalation study (BASF, 1978) with a NOAEC for local effects (as most sensitive parameter) at 21 ppm (111.9 mg/m3). On the basis of the NOAEC of 21 ppm the MAK-value of n-butyl acrylate was determined to be 2 ppm. This national OEL (long-term) is taken as DNEL, it is based on actual and well documented toxicological information and evaluation of health effects, in which the approach how it is derived is scientifically justified and is therefore in accordance with ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose (concentration)-response for human health (May 2008).

 

·        MAK evaluation n-butyl acrylate, Toxikologische arbeitsmedizinische Begründung von MAK-Werten, 42. Lieferung 2000

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:
DNEL (Derived No Effect Level)
Value:
1.52 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
8.4
Dose descriptor:
other: German MAK Value for n-Butyl Acrylate (2 ppm); converted to mg/m3 and adjusted for the difference in molecular weight
AF for dose response relationship:
1
Justification:
Not required
AF for differences in duration of exposure:
4.2
Justification:
The possible exposure time may be increased by a factor 3 (8 hrs. vs. 24 hrs) and by a factor 1.4 (5 days/week vs. 7 days/week) longer.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
2
Justification:
According to the ECHA Guidance document the intraspecies factor is by a factor 2 higher for general population than for worker.
AF for the quality of the whole database:
1
Justification:
Not required
AF for remaining uncertainties:
1
Justification:
Not required
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

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:
low hazard (no threshold derived)

Additional information - General Population

Since end-use consumer products contain only trace levels of acrylic acid and esters (as a result of polymerization), consumer exposure to acrylate monomers is likely to be low (SRI, 2001).

SRI, 2001 . CEH Marketing Research Report, Acrylic Acid and Esters, 606 .4000A, Chemical Economics Handbook -SRI International .