Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
144
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:
2.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

This dossier is a registration update of a previously notified substance and contains the info on the required endpoints under the previous legislation. In addition, this substance is notified as a well contained transported isolated intermediate.

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 200 mg/kg bw/day from a 28-day study in rat.

Assessment factors:

- Route-to-route extrapolation: 1

- Interspecies: 4

- Intra-species for workers: 3

- Exposure duration subacute to chronic: 6

This results in a total assessment factor of 72, indicating a DNEL of 200/72 = 2.8 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 the inhalation route can be derived by route-to-route extrapolation from an oral NOAEL of 200 mg/kg bw/day from a 28-day study in rat.

- Corrected inhalatory NOAEC = oral NOAEL x (1/sRVrat)x(ABSoral-rat/ABSinh-human)x(sRVhuman/wRV) = 200 mg/kg bw/day x (1/0.38m3)x(1)x(6.7m3/10m3)

= 352.6 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 subacute to chronic: 6

This results in a total assessment factor of 144, indicating a DNEL of 352.6/144 = 2.4 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:
0.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
240
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:
1.7 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
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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
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 200 mg /kg bw/day from a 28-day study in rat.

Assessment factors:

- Route-to-route extrapolation: 1

- Interspecies: 4

- Intra-species for general population: 5

- Exposure duration subacute to chronic: 6

This results in a total assessment factor of 120, indicating a DNEL of 200/120 = 1.7 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 the inhalation route can be derived by route-to-route extrapolation from an oral NOAEL of 200 mg/kg bw/day from a 28-day study in rat.

- Corrected inhalatory NOAEC = oral NOAEL x (1/sRVrat)x(ABSoral-rat/ABSinh-human)= 200 mg/kg bw/day x (1/1.15m3)x(1)

= 173.9 mg/m3

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

- Route-to-route extrapolation: 2

- Interspecies: 4

- Intra-species for general population: 5

- Exposure duration subacute to chronic: 6

This results in a total assessment factor of 240, indicating a DNEL of 173.9/240 = 0.7 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 200 mg/kg bw/day from a 28-day study in rat.

Assessment factors:

- Interspecies: 4

- Intra-species for general population: 5

- Exposure duration subacute to chronic: 6

This results in a total assessment factor of 120, indicating a DNEL of 200/120 = 1.7 mg/kg bw/day.

ECETOC TR110 recommendations were followed for deriving the DNELs.

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