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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.