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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
6.96 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
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:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Acute toxicity

The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.

Local effects

Since no local effects were described, the DNELs are based on the systemic effects only.

LONG -TERM DNEL

The long-term DNEL is based on the most critical NOAEL seen in the repeated/ reproduction study with a NOAEL of 1000 mg/kg.

long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =

1000 * (1/ sRV(a) * 0.67 (b) )

--------------------------------------------------------------------------------------------------------------------------- =

                                               25 (c)

 

1000* (1/ 0.384) * 0.67

--------------------------------------------------------              = .6.96 mg/m3

                      25

(a) Standard respiratory volume (sRV) rat:0.384 m3/kg

(b) correction for worker respiratory volume (conservative default for route to route)

(c)interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 5 * 2 )

 

 

long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)

1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 10 mg/kg bw/day

(a) route to route extrapolation oral to dermal

(b) assessment factors (interspecies * intraspecies (4*2.5) * 5)

(c) Correction for duration from subacute to chronic (2)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
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:
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
DNEL related information

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
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Acute toxicity

The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified for acute toxicity hazards, no acute DNELs need to be calculated.

Local effects

Since no local effects were described, the DNELs are based on the systemic effects only.

LONG -TERM DNEL

The long-term DNEL is based on the most critical NOAEL seen in the repeated/ reproduction studywith a NOAEL of 1000 mg/kg.

long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =

1000 * (1/ sRV(a))

--------------------------------------------------------------------------------------------------------------------------- =

                                               2.5*10*2 (b)

 

1000* (1/ 1.15)

--------------------------------------------------------              = 23 mg /m3

                50

(a) Standard respiratory volume (sRV) rat for general public (24h):1.15 m3/kg

(b) Interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 10 * 2 )

 

long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)

1000 *1 (a) / 4*2.5*5 (b) *2 (c) = 5.01 mg/kg bw/day

(a) route to route extrapolation oral to dermal

(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)

(c) Correction for duration from subchronic to chronic (2)

long-term DNEL for the oral route (systemic effects)

1000 / 4*2.5*5 (a) *2(b) = 5.01 mg/kg bw/day

(a) assessment factors (interspecies * intraspecies (4*2.5) * 10)

(b) Correction for duration from subchronic to chronic (2)

Endpoints are given using a read across.

Full read across report is attached below