Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
875 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL

Workers - Hazard for the eyes

Additional information - workers

TIS-M is classified as a skin sensitiser. It is stated in Appendix R. 8-10 of the ECHA Guidance on information requirements and chemical safety assessment that the EC3 value from a LLNA can be considered as the LOAEL for induction, however, a reliable EC3 value could not be calculated for TIS-M in the LLNA therefore, it is not possible to calculate a DNEL for this endpoint. The use of Risk Management Measures including PPE are considered sufficient to prevent any hazard from local dermal exposure. In addition, this substance is not supplied in the neat form, and instead is only supplied in the EU as a monomeric component of a liquid polymer. TIS-M is present at < 0.1% in the final polymer product imported into the EU and the possibility of exposure is therefore considered to be extremely slight.  

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
437.5 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
240
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62.5 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

TIS-M is classified as a skin sensitiser. It is stated in Appendix R. 8-10 of the ECHA Guidance on information requirements and chemical safety assessment thatthe EC3 value from a LLNA can beconsidered as the LOAEL for induction, however, a reliable EC3 value could not be calculated for TIS-M in the LLNA therefore, it is not possible to calculate a DNEL for this endpoint. The use of Risk Management Measures including PPE are considered sufficient to prevent any hazard from local dermal exposure. In addition, this substance is not supplied in the neat form, and instead is only supplied in the EU as a monomeric component of a liquid polymer. TIS-M is present at < 0.1% in the final polymer product imported into the EU and the possibility of exposure is therefore considered to be extremely slight.