Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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