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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
48
Modified dose descriptor starting point:
NOAEC
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:
20.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Dermal Worker-DNEL-long-term systemic

There is no data available on systemic toxicity following repeated dermal exposures. However, a DNEL for dermal route can be derived by route-to-route extrapolation from an oral NOAEL of 500 mg complexation products/kg bw/day from a 90-day study in rat.

 

Assessment factors:

- Route-to-route extrapolation: 1

- Interspecies: 4

- Intra-species for workers: 3

- Exposure duration subchronic to chronic: 2

- NOAEL/NOAEL: 3

 

This results in a total assessment factor of 24, indicating a DNEL of 500/24 = 20.8 mg/kg bw/day.

 

Inhalation Worker-DNEL-long-term systemic

There is no data available on systemic toxicity following repeated inhalation exposures. However, a DNEL for dermal route can be derived by route-to-route extrapolation from an oral NOAEL of 500 mg complexation products/kg bw/day from a 90-day study in rat.

- Corrected inhalatory NOAEC = oral NOAEL x (1/sRVrat)x(ABSoral-rat/ABSinh-human)x(sRVhuman/wRV) = 500 mg/kg bw/day x (1/0.38m3)x(1)x(6.7m3/10m3)

= 882 mg/m3

 

ABS: Absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory Volume

- Route-to-route extrapolation: 2

- Interspecies: 4

- Intra-species for workers: 3

- Exposure duration subchronic to chronic: 2

 

This results in a total assessment factor of 48, indicating a DNEL of 882/48 = 18.4 mg/m3.

 

ECETOC TR110 recommendations were followed for deriving the DNELs

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEC
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:
12.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

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

General Population - Hazard for the eyes

Additional information - General Population

Dermal General population-DNEL-long-term systemic

There is no data available on systemic toxicity following repeated dermal exposures. However, a DNEL for dermal route can be derived by route-to-route extrapolation from an oral NOAEL of 500 mg complexation products/kg bw/day from a 90-day study in rat.

 

Assessment factors:

- Route-to-route extrapolation: 1

- Interspecies: 4

- Intra-species for general population: 5

- Exposure duration subchronic to chronic: 2

 

This results in a total assessment factor of 40, indicating a DNEL of 500/40 = 12.5 mg/kg bw/day.

 

Inhalation General population-DNEL-long-term systemic

There is no data available on systemic toxicity following repeated inhalation exposures. However, a DNEL for dermal route can be derived by route-to-route extrapolation from an oral NOAEL of 500 mg complexation products/kg bw/day from a 90-day study in rat.

- Corrected inhalatory NOAEC = oral NOAEL x (1/sRVrat)x(ABSoral-rat/ABSinh-human)= 500 mg/kg bw/day x (1/1.15m3)x(1)

= 435 mg/m3

 

ABS: Absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory Volume

- Route-to-route extrapolation: 2

- Interspecies: 4

- Intra-species for workers: 5

- Exposure duration subchronic to chronic: 2

 

This results in a total assessment factor of 80, indicating a DNEL of 435/80 = 5.4 mg/m3.

 

Oral General population-DNEL-long-term systemic

There is no data available on systemic toxicity following repeated dermal exposures. However, a DNEL for dermal route can be derived by route-to-route extrapolation from an oral NOAEL of 500 mg complexation products/kg bw/day from a 90-day study in rat.

 

Assessment factors:

- Interspecies: 4

- Intra-species for workers: 5

- Exposure duration subchronic to chronic: 2

 

This results in a total assessment factor of 40, indicating a DNEL of 500/40 = 12.5 mg/kg bw/day.

 

ECETOC TR110 recommendations were followed for deriving the DNELs.