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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
47 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: most closely equivalent to ECHA REACH Guidance
Overall assessment factor (AF):
18.75
Modified dose descriptor starting point:
NOAEC
Value:
882 mg/m³
Explanation for the modification of the dose descriptor starting point:
ECHA REACH Guidance default procedure: correction factor = 1/0.38m3/kg x 1/2 x 6.7m3/person (8h) / 10m3/person (8h)
AF for dose response relationship:
0.5
Justification:
The default AF of 1 for NOAEL was modified because of the absence of any adverse effects at the higest dose level tested
AF for differences in duration of exposure:
3
Justification:
The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications suggesting accumulation. Moreover in an one-generation reproduction toxicity study applying treatment periods above 28 days an NOAEL of 1000 mg/kg bw was determined for parental toxicity.
AF for interspecies differences (allometric scaling):
1
Justification:
No AF applied because already implemented in the calculation of the correct starting point
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance default AF
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance default AF for workers
AF for the quality of the whole database:
1
Justification:
Good quality
AF for remaining uncertainties:
1
Justification:
No AF applied
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: most closely equivalent to ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
worst case assumption: absorption after dermal exposure does not deceed absorption after oral ingestion
AF for dose response relationship:
0.5
Justification:
The default AF of 1 for NOAEL was modified because of the absence of any adverse effects at the higest dose level tested
AF for differences in duration of exposure:
3
Justification:
The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications suggesting accumulation. Moreover in an one-generation reproduction toxicity study applying treatment times above 28 days an NOAEL of 1000 mg/kg bw was determined for parental toxicity.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance default AF for rat-human
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance default AF
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance default AF for worker
AF for the quality of the whole database:
1
Justification:
Good quality
AF for remaining uncertainties:
1
Justification:
No AF applied
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The intended use of the pigment is coloration of plastic materials. As such the pigment is bound in a matrix which prevents a relevant exposure of the general population. Therefore and because of the very low toxicity DNELs for the general population were not derived.