Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

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:
100 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
40 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL

Local effects

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/cm²
DNEL related information
Overall assessment factor (AF):
3
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Additional information - workers

It is not necessary to derive a DNEL for inhalation exposure as the substance has negligible vapour pressure and the use pattern does not involve risk of exposure to aerosols, particules or droplets of inhalable particle size.

Acute dermal systemic DNEL based on LD0 in rats (all surrogates). Assessment factor 10(interspecies)x5(workers)=50. Note that this was a limit test and the true NOAEL is likely to be much higher.

Acute local effects DNEL based on quantity used in skin irritation study that produced a reaction not requiring classification as a skin irritant. Assessment factor =1(interspecies local effect)x3(intraspecies for worker, local effects).

Repeat dose dermal systemic DNEL based on NOAEL for oral repeat dose study in rats with surrogate substance and route to route extrapolation. Assessment factor 10(interspecies)x5(workers intraspecies)x2(length of study)x0.1(assuming 10% maximum absorption, a very conservative figure)=10.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

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

Local effects

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13 mg/cm²
DNEL related information
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
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):
100
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

It is not necessary to derive a DNEL for inhalation exposure as the substance has negligible vapour pressure and the use pattern does not involve risk of exposure to aerosols, particules or droplets of inhalable particle size. The general population have little opportunity in any case for exposure to this substance based on use patterns. The only members of the population expected to use materials containing this substance will be adults of a working age, hence the intraspecies factor for workers is most appropriate.

Acute dermal systemic DNEL based on LD0 in rats (all surrogates). Assessment factor 10(interspecies)x5(general population excluding children and older persons)=50.

Acute oral systemic DNEL based on LD0 in rats (all surrogates). Assessment factor 10(interspecies)x5(general population excluding children and older persons)=50.

Acute local effects DNEL based on quantity used in skin irritation study that produced a reaction not requiring classification as a skin irritant. Assessment factor =1(interspecies local effect)x5(intraspecies for general population excluding children and older persons).

Repeat dose dermal systemic DNEL based on NOAEL for oral repeat dose study in rats with surrogate substance and route to route extrapolation. Assessment factor 10(interspecies)x5(general population excluding children and older persons)x2(length of study)x0.1(assuming 10% maximum absorption, a very conservative figure!)=10.

Repeat dose oral systemic DNEL based on NOAEL for oral repeat dose study in rats with surrogate substance. Assessment factor 10(interspecies)x5(general population excluding children and older persons)x2(length of study)=100.