Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.25 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Evaluation of WHO CICAD 36
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.25 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Evaluation of WHO CICAD 36
Overall assessment factor (AF):
1

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.25 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Evaluation of WHO CICAD 36
Overall assessment factor (AF):
1
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.25 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Evaluation of WHO CICAD 36
Overall assessment factor (AF):
1

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
Explanation for the modification of the dose descriptor starting point:

According to the results of an acute dermal toxicity study with ethyl 2-cyanoacrylate, LD50 is greaterthna 2000 mg/kg bw. No effects are described from human experience after short-term skin exposure to ethyl 2-cyanoacrylate.

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Based on the evaluated physico-chemical properties of ethyl 2-cyanoacrylate, the test item is not classified as corrosive, explosive or as flammable. Ethyl 2-cyanoacrylate crystallizes at -71°C and melts at at -31°C. Under usual working conditions the monomer is a fluid, which polymerizes after contact to moisture in ambient air or to water. Therefore, it can only processed in sealed processes as long as polymerization should not occur.

Irritation can occur through inhalation or contact to the eyes, even though effects are considered mild.

Based on its irritating properties, a DNEL for inhalation of 1.8 ppm (9.25 mg/m3) was derived.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.25 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Evaluation of WHO CICAD 36
Overall assessment factor (AF):
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.25 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Evaluation of WHO CICAD 36
Overall assessment factor (AF):
1

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.25 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Evaluation of WHO CICAD 36
Overall assessment factor (AF):
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.25 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Evaluation of WHO CICAD 36
Overall assessment factor (AF):
1

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:
low hazard (no threshold derived)

Additional information - General Population

Based on the evaluated physico-chemical properties of ethyl 2-cyanoacrylate, the test item is not classified as corrosive, explosive or as flammable.Ethyl 2-cyanoacrylate crystallizes at -71°C and melts at at -31°C. Under usual working conditions the monomer is a fluid, which polymerizes after contact to moisture in ambient air or to water. Therefore, it can only processed in sealed processes as long as polymerization should not occur.

Irritation can occur through inhalation or contact to the eyes, even though effects are considered mild.

Based on its irritating properties, a DNEL for inhalation of 1.8 ppm (9.25 mg/m3) was derived.