Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12 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):
25
Dose descriptor starting point:
NOAEL
Value:
350 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
309 mg/m³
Explanation for the modification of the dose descriptor starting point:

No inhalation study available. Thus, extrapolation from 90D oral study wtih a NOAEL of 350 mg/kg bw/d with respect to repeated dose toxicity.

Using this value as a starting point for chronic DNEL derivation for workers with respect to dermal and inhalational exposure:

 

DNEL, inhalation, workers:

Adjustment of dose metric to inhalational concentration:

The REACH R.8 guidance uses an inhalation volume for rats of 0.38 m3/kg for 8 hr exposure

Thus NOAEL to NOAEC conversion:

NOAEC rats = 350 mg/kg/d / 0.38 m3/kg =  921 mg/m3

 

As no data is available for absorption rate for oral exposure versus inhalation exposure a default factor of 2 is used for accounting for the potential for higher absorption by inhalation :

NOAEC rats = 921 mg/m3 / 2 = 461 mg/m3

Correction factor for increased inhalation volume during work:

NOAEC worker, 8hr = 6.7 m3/ 10m3 x 461 mg/m3 = 309 mg/m3

AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
2
Justification:
Extrapolation from 90 D study to chronic exposure situation
AF for interspecies differences (allometric scaling):
1
Justification:
not used when dose metric is already concerted to mg/m3
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
77 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: SCOEL OEL value on acrylic acid as indicative DNEL value for 2-phenoxyethyl acrylate.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.5 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):
100
Dose descriptor starting point:
NOAEL
Value:
350 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal repeated dose studies available. Absorption by dermal route is by default considered identical to absorption from oral route.
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
extrapolation from 90D study to chronic exposure situation
AF for interspecies differences (allometric scaling):
4
Justification:
default
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default
AF for the quality of the whole database:
1
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:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

2-phenoxyethyl acrylate has low acute toxicity (oral and dermal). No data for the acute inhalational toxicity is available. Results from irritation studies (skin and eye) indicates a no to low potential. The substance has been shown to be a sensitizer in a Guinea pig maximisation test and should therefore accordingly be classified as Skin. Sens. 1A. Based on the data from an OECD 422 study (conducted in 2012/2013), a NOAEL of 300 mg/kg bw/day for systemic repeated dose toxicity is concluded. Further, a NOAEL of 800 mg/kg bw/day (male) and 300 mg/kg bw/day (female, based on post implantation losses) for reproductive toxicity was concluded.

Exposure of 2-phenoxyethyl acrylate to humans is only relevant for workers in industrial processing and professional uses. Based on the physical/chemical properties, dermal absorption is considered the most relevant exposure route. DNEL for systemic effect of 3.5 mg/kg bw/day has been derived based on a NOAEL of 350 mg/kg bw/day for sytemoc effects in relation to repeated dose toxicity in a OECD 408 study (90D oral exposure). This DNEL value is considered conservative as dermal absorption is considered equal to oral absorption. No DNEL for skin sensitising effects can be derived, thus dermal exposure is considered most critical route of exposure.

Based on the NOAEL of 350 mg/kg/bw /day from oral exposure, a DNEL for inhalation of 12 mg/m3 was derived by route-to-route extrapolation for protection against any systemic effects.

As hydrolysis of 2-phenoxyethyl acrylate into acrylic acid and 2-phenoxyethanol may occur, there is a potential of local toxicity in the lung due to the formation of acrylic acid. In 2012, SCOEL derived an OEL value of 10 ppm (29 mg/m3) for acrylic acid. 10 ppm of 2 -phenoxyethyl acrylate equivalates to 77 mg/m3. This worst case and indicative DNEL value for local effects is less restrictive than the DNEL for systemic effects (10 mg/m3).

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

Exposure of consumers/general population to 2-phenoxyethyl acrylate is not relevant as only used in industrial settings and professional uses. Therefore, no hazard identification for consumers/general population considered necessary.