Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

The most appropriate endpoint for derivation of a DNEL is the rat oral NOAEL of 50 mg/kg bw/d taken from 2 well conducted subchronic toxicity studies, mainly based on liver weight effects.

Based on the acute toxicity data, DNELs don't need to be derived for local or systemic effects for the worker population since the material has a low potential for acute toxicity.

Worker long term exposure - systemic effects (dermal and inhalation) DNELs were calculated from the NOAEL, assuming a 100% dermal absorption rate (worst case). The value was divided by an adjustment factor of 100 (exposure duration factor of 2, interspecies factor of 10, and intraspecies (worker population) factor of 5), leading to a DNEL of 0.5 mg/kg/d.

The corrected worker inhalation starting point was the corrected NOAEC of 88.2 mg/m³ and was derived from the oral NOAEL of 50 mg/kg/d by multiplying by the inverse of the standard respiratory volume of the rat during an 8 hour period (2.63) and multiplied by the ratio of standard respiratory volume for humans to the 8 hour worker standard respiratory volume (0.67). The corrected starting point was adjusted by a factor of 25 (interspecies factor of 2.5, intraspecies factor (worker) of 5, and exposure duration of 2), resulting in a calculated DNEL of 3.5 mg/m³.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.87 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

The most appropriate endpoint for derivation of a DNEL is the rat oral NOAEL of 50 mg/kg bw/d taken from 2 well conducted subchronic toxicity studies, mainly based on liver weight effects.

Based on the acute toxicity data, DNELs don't need to be derived for local or systemic effects for the general population since the material has a low potential for acute toxicity.

General population long term exposure - systemic effects (oral, dermal and inhalation) DNELs were calculated from the NOAEL, assuming a 100% dermal absorption rate (worst case). The value was divided by an adjustment factor of 200 (exposure duration factor of 2, interspecies factor of 10, and intraspecies (general population) factor of 10), leading to a DNEL of 0.25 mg/kg/d.

The corrected general population inhalation starting point was the corrected NOAEC of 43.5 mg/m³ and was derived from the oral NOAEL of 50 mg/kg/d by multiplying by the inverse of the standard respiratory volume of the rat during a 24 hour period (0.87). The corrected starting point was adjusted by a factor of 50 (interspecies factor of 2.5, intraspecies factor (general population) of 10, and exposure duration of 2), resulting in a calculated DNEL of 0.87 mg/m³.

The general population oral starting point is 50 mg/kg/d. An adjustment factor of 200 is applied (interspecies factor of 10, intraspecies factor (general population) of 10, and exposure duration of 2), leading to a DNEL of 0.25 mg/kg bw/day.