Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
370.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Dose descriptor starting point:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Modified dose descriptor starting point:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
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:
267 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Dose descriptor:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Dose descriptor starting point:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Modified dose descriptor starting point:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
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)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The long-term DNELs for EMA for all relevant routes and groups were derived by interpolation between the respective DNELs for MMA and n-BMA, weighed by the difference in molecular weight.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
76 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Dose descriptor starting point:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Modified dose descriptor starting point:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
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:
189.8 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Dose descriptor:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Dose descriptor starting point:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
Modified dose descriptor starting point:
other: Interpolation between the respective DNELs of the closest analogous substances in the category, i.e. MMA and nBMA.
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)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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

The long-term DNELs for EMA for all relevant routes and groups were derived by interpolation between the respective DNELs for MMA and n-BMA, weighed by the difference in molecular weight.