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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.8 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC
Value:
74 mg/m³
Explanation for the modification of the dose descriptor starting point:
Not necessary, because of existing 90 d study with inhalative exposure to rats.
AF for dose response relationship:
1
Justification:
The data of the studies indicate, that the dose-response curve is flat.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
The relevant toxic effect is a local irritation, differences in the metabolic rate are not relevant.
AF for other interspecies differences:
1
Justification:
Besides a local irritation and its consequences, no specific effects were observed.
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies extrapolation.
AF for the quality of the whole database:
1
Justification:
There exist guideline studies to all relevant toxicological endpoints.
AF for remaining uncertainties:
0.5
Justification:
The data are consistent between the different toxicological studies. Acrylic acid to Magnesium acrylate: AF=0.5 Taking into account the higher molecular weight of Magnesium acrylate (ca. 2 times higher) compared to acrylic acid and besides that the general lower toxicity the DNEL for Magnesium acrylate should be at least two times higher than for acrylic acid.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.8 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
74 mg/m³

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.8 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
The data of the studies indicate, that the dose-response curve is flat.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
The relevant toxic effect is a local irritation, differences in the metabolic rate are not relevant.
AF for other interspecies differences:
1
Justification:
Besides a local irritation and its consequences, no specific effects were observed.
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies extrapolation.
AF for the quality of the whole database:
1
Justification:
There exist guideline studies to all relevant toxicological endpoints.
AF for remaining uncertainties:
0.5
Justification:
The data are consistent between the different toxicological studies. Acrylic acid to Magnesium acrylate: AF=0.5 Taking into account the higher molecular weight of Magnesium acrylate (ca. 2 times higher) compared to acrylic acid and besides that the general lower toxicity the DNEL for Magnesium acrylate should be at least two times higher than for acrylic acid.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.8 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.2 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
LOAEL
Value:
11 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not necessary, because of existing chronic study with dermal exposure to mice.
AF for dose response relationship:
1
Justification:
The data of the studies indicate, that the dose-response curve is flat.
AF for differences in duration of exposure:
1
Justification:
A study with chronic dermal application is available
AF for interspecies differences (allometric scaling):
1
Justification:
The relevant toxic effect is a local irritation, differences in the metabolic rate are not relevant.
AF for other interspecies differences:
1
Justification:
Besides a local irritation and its consequences, no specific effects were observed.
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies extrapolation.
AF for the quality of the whole database:
2
Justification:
LOAEL/NOEL extrapolation. There exists only a LOAEL in the chronic toxicity study with dermal application.
AF for remaining uncertainties:
0.5
Justification:
The data are consistent between the different toxicological studies. Acrylic acid to Magnesium acrylate: AF=0.5 Taking into account the higher molecular weight of Magnesium acrylate (ca. 2 times higher) compared to acrylic acid and besides that the general lower toxicity the DNEL for Magnesium acrylate should be at least two times higher than for acrylic acid.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
400 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not necessary, because of existing acute study with Magnesium acrylate with dermal exposure to rats.
AF for dose response relationship:
1
Justification:
The data of the studies indicate, that the dose-response curve is flat.
AF for interspecies differences (allometric scaling):
1
Justification:
The relevant toxic effect is a local irritation, differences in the metabolic rate are not relevant.
AF for other interspecies differences:
1
Justification:
Metabolism is not a driving force for the local effect.
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies extrapolation (worker).
AF for the quality of the whole database:
1
Justification:
There exists a acute dermal toxicity study with Magnesium acrylate.
AF for remaining uncertainties:
1
Justification:
The data are consistent between the different toxicological studies.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.052 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
other: LOAEL: 11 mg/kg bw day, no data on area of application. Assuming 1 cm2 results in 0.26 mg/cm2.
AF for dose response relationship:
1
Justification:
The data of the studies indicate, that the dose-response curve is flat.
AF for differences in duration of exposure:
1
Justification:
A study with chronic dermal application is available
AF for interspecies differences (allometric scaling):
1
Justification:
The relevant toxic effect is a local irritation, differences in the metabolic rate are not relevant.
AF for other interspecies differences:
1
Justification:
Besides a local irritation and its consequences, no specific effects were observed.
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies extrapolation.
AF for the quality of the whole database:
2
Justification:
LOAEL/NOEL extrapolation. There exists only a LOAEL in the chronic toxicity study with dermal application.
AF for remaining uncertainties:
0.5
Justification:
The data are consistent between the different toxicological studies. Acrylic acid to Magnesium acrylate: AF=0.5 Taking into account the higher molecular weight of Magnesium acrylate (ca. 2 times higher) compared to acrylic acid and besides that the general lower toxicity the DNEL for Magnesium acrylate should be at least two times higher than for acrylic acid.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: NOAEL (acute dermal toxicity) = 2000 mg/kg bw per day (application site 4 cm x4 cm)
AF for dose response relationship:
1
Justification:
The data of the study indicate, that the dose-response curve is flat.
AF for interspecies differences (allometric scaling):
1
Justification:
The relevant toxic effect is a local irritation, differences in the metabolic rate are not relevant.
AF for other interspecies differences:
1
Justification:
Metabolism is not a driving force for the local effect.
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies extrapolation (worker).
AF for the quality of the whole database:
1
Justification:
There exists a acute dermal toxicity study with Magnesium acrylate.
AF for remaining uncertainties:
1
Justification:
The data are consistent between the different toxicological studies.

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

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