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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.6 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):
75
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
DNEL value:
2.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

No inhalation study available. Thus, extrapolation from OECD 422 oral study wtih a NOAEL of 225 mg/kg bw/d with respect to repeated dose systemic 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 = 225 mg/kg/d / 0.38 m3/kg =  592 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 = 592 mg/m3 / 2 = 296 mg/m3

Correction factor for increased inhalation volume during work:

NOAEC worker, 8hr = 6.7 m3/ 10m3 x 296 mg/m3 = 198 mg/m3

Using an overall assessment factor of 75 a DNEL of 2.6 mg/m3 can be derived.

AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
6
Justification:
Extrapolation from 28 D study to chronic exposure situation
AF for interspecies differences (allometric scaling):
1
Justification:
not used when dose metric is converted 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:
no hazard identified
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 starting point for an indicative DNEL value for Ethoxyethoxyethyl acrylate (EOEOEA)
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:
0.083 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):
300
Dose descriptor starting point:
NOAEL
DNEL value:
25 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

28D to chronic study equals an AF=6

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
extrapolation from 28D 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:
medium hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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:
medium hazard (no threshold derived)

Additional information - workers

Ethoxyethoxyethyl acrylate(EOEOEA) is acute toxic both dermally and orally and should be classified as Acute Tox. 3. And Acute Tox. 4., respectively. No data for the acute inhalational toxicity is available.

Results from irritation studies (skin and eye) suggests that EOEOEA should be classified as Skin Irrit.2 and Eye Irrit. 2. Moreover, EOEOEA should be classified as Skin Sens 1A based on data from a Guinea pig maximisation test

Based on the data from an oral OECD 422 study on the read-across substance a NOAEL of 25 mg/kgbw/day forsystemicrepeated dose toxicity is concluded. Further, a NOAEL of 225 mg/kgbw/day for reproductive toxicity was concluded.

 

Exposure of EOEOEA to humans is only relevant for workers in industrial processing and professional uses. Based on the physical/chemical properties, dermal exposure is considered the most relevant exposure route. DNEL forsystemic effectof 0.083 mg/kgbw/day has been derived based on a NOAEL of 25 mg/kgbw/day for systemic effects in relation to repeated dose toxicity in an OECD 422 study (28D 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 25 mg/kg/bw /day from oral exposure, a DNEL for inhalation of 0.29 mg/m3 was derived by route-to-route extrapolation for protection against any systemic effects.

Kan vi overhoved bruge dette med hydrolysis for M170?

As hydrolysis of EOEOEA into acrylic acid and 2 -2 -phenylphenoxyethanol 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

biphenyl-2 -ol, ethoxylated, esters of acrylic acid equivalates to 77 mg/m3. This indicative DNEL value for local effects is far less restrictive than the DNEL for systemic effects (0.29 mg/m3).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

No hazard identification for consumers/general population considered necessary.

Exposure of consumers/general population to the subtance is not relevant as only used in industrial settings and for professional uses.

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
DNEL related information
Explanation for the modification of the dose descriptor starting point:

No hazard identification for consumers/general population considered necessary.

Exposure of consumers/general population to the subtance is not relevant as only used in industrial settings and for professional uses.

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
DNEL related information
Explanation for the modification of the dose descriptor starting point:

No hazard identification for consumers/general population considered necessary.

Exposure of consumers/general population to the subtance is not relevant as only used in industrial settings and for professional uses.

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

No hazard identification for consumers/general population considered necessary.

Exposure of consumers/general population to the subtance is not relevant as only used in industrial settings and for professional uses.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

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