Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/m³
DNEL related information
DNEL derivation method:
other: The general exposure limit for inhalable dust was applied
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/m³
DNEL related information
DNEL derivation method:
other: The general exposure limit for inhalable dust is applied

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/m³
DNEL related information
DNEL derivation method:
other: The general exposure limit for inhalable dust is applied
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
33.3 mg/kg bw/day
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The dermal route is typically covered by oral route information in the absence of data for this administration route. Since no data on penetration through skin are available, the dermal absorption property is evaluated based on physico-chemical parameters. The test substance is practically insoluble in both water and organic solvents with a rather large molecular weight (Mw= 418). As a result, absorption via the dermal route is expected to be below 10%. This is taken into account by modifying the NOAEL with a factor of 10 (ECHA GD chapter R7c).

AF for dose response relationship:
1
Justification:
The dose discriptor used was already a NOAEL.
AF for differences in duration of exposure:
6
Justification:
Default value compensating for chronic studies by using sub-acute study values.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value extrapolating from rat to human.
AF for other interspecies differences:
2.5
Justification:
Default value.
AF for intraspecies differences:
5
Justification:
Default value used for workers.
AF for the quality of the whole database:
1
Justification:
Reliable and adequate guideline study.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Identification of relevant dose descriptor

The test substance belongs to a category of organic pigments that all share a similar chemical structure (see CSR for category justification). Within this category, several substances were selected for testing in repeated dose toxicity studies. None of these studies revealed adverse effects for any tested substance up to the highest doses tested. Based on these results, together with toxicokinetic considerations, it was concluded that the members of this category are not taken up by the body after oral ingestion and are therefore not systemically available. Nevertheless, as worst case assessment, DNELs for systemic effects were established. In the available 28-day and 90-day repeated dose studies performed with several category members, NOAELs ranging from 1000 mg/kg to 5000 mg/kg body weight were established (highest doses tested). Since the data obtained with individual category members were shared within the category, it was chosen to select the lowest NOAEL of 1000 mg/kg obtained after 28-day administration as common dose descriptor for every substance within the group. This value was therefore used as starting point to derive the DNELs.

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:
DNEL (Derived No Effect Level)
Value:
16.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The dermal route is typically covered by oral route information in the absence of data for this administration route. Since no data on penetration through skin are available, the dermal absorption property is evaluated based on physico-chemical parameters. The test substance is practically insoluble in both water and organic solvents with a rather large molecular weight (Mw= 418). As a result, absorption via the dermal route is expected to be below 10%. This is taken into account by modifying the NOAEL with a factor of 10 (ECHA GD chapter R7c).

AF for dose response relationship:
1
Justification:
The dose discriptor used was already a NOAEL.
AF for differences in duration of exposure:
6
Justification:
Default value compensating for chronic studies by using sub-acute study values.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value extrapolating from rat to human.
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Reliable and adequate guideline study.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
The dose discriptor used was already a NOAEL.
AF for differences in duration of exposure:
6
Justification:
No time extrapolation was necessary.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value extrapolating from rat to human.
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Reliable and adequate guideline study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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

Identification of relevant dose descriptor

The dose descriptor chosen is the same as for workers (see above). The NOAEL of 1000 mg/kg was used as starting point to derive the DNELs.