Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Workers will not be exposed to the substance as only the end-product (solid ink preparation) will be imported into the EU.

For risk assessment purposes, workers will be treated the same as the general population.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
3 000
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
3 000
Modified dose descriptor starting point:
NOAEC

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:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

Corsair Resin 5 showed no toxicologically adverse effects in any of the conducted studies.

  • Acute oral toxicity (rat): LD50 > 5000 mg/kg
  • Acute dermal toxicity (rat): LD50 > 2000 mg/kg
  • Skin irritation (rabbit): not irritating to the skin
  • Eye irritation (rabbit): not irritating to the eyes
  • Skin sensitisation (mouse local lymph node assay): not sensitising to the skin
  • Subacute oral toxicity (rat): NOAEL >= 1000 mg/kg bw/d
  • Reproduction/developmental toxicity screening (rat): NOAEL >= 1000 mg/kg bw/d
  • Ames test: not mutagenic
  • Chromosome aberration test: not clastogenic
  • Mouse lymphoma test: not mutagenic

DNEL's have been derived from the NOAEL values of 1000 mg/kg bw/d for repeated dose toxicity and reproductive/developmental toxicity. An overall assessment factor of 300 was used and a body weight of 60 kg. The assessment factor is calculated as follows: 4 (allometric scaling) x 2.5 (other interspecies variation) x 10 (intraspecies variation general population) x 3 (exposure duration subacute to sub/semi-chronic) x 1 (route-to-route extrapolation) x 1 (dose-respons). For inhalation exposure, an extra factor of 10 is used for extrapolation from the oral to the inhalatory situation(oral absorption factor 10%, inhalatory absorption factor 100%, see toxicokinetic assessment in section 7.1)