Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
4.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
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

Assessment factors are applied as indicated in the ECHA guidance document R.8 (May 2008).

Kidney is the most sensitive organ as derived from oral studies with Pigment Red 57;1, Pigment Red 48:2, Pigment Red 57 Sr and the sodium salt of Pigment Red 57. No experimental data is available for repeated dose inhalation toxicity, so this DNEL is derived by route-to-route interpolation. The DNEL for dermal exposure is calculated based on an 18 month skin painting study with the single dose of 50 mg/kg bw for which no adverse effects on kidneys were reported. Calculation of the DNEL for dermal systemic exposure by route-to-route interpolation yields a similar value (Starting point: 25 mg/kg bw; Interspecies = 1 (mice and rat), allometric scaling = 4, intraspecies = 5 (worker), exposure = 1, quality of database = 1). It is expected that systemic availability after ingestion is higher because the organic metal salt is dissolved in the acidic environment of the stomach. Overall, the no-effect level for systemic dermal exposure is probably higher than the DNEL that can be derived from the available data.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEC
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:
0.36 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
140
Modified dose descriptor starting point:
NOAEL
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:
0.63 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
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

Assessment factors are applied as indicated in the ECHA guidance document R.8 (May 2008).

Kidney is the most sensitive organ as derived from oral studies with Pigment Red 57;1, Pigment Red 48:2, Pigment Red 57 Sr and the sodium salt of Pigment Red 57. The DNEL for dermal exposure is calculated based on an 18 month skin painting study with the single dose of 50 mg/kg bw for which no adverse effects on kidneys were reported. Calculation of the DNEL for dermal systemic exposure by route-to-route interpolation yields a similar value (Starting point: 25 mg/kg bw; Interspecies = 1 (mice and rat), allometric scaling = 4, intraspecies = 10 (general population), exposure = 1, quality of database = 1). It is expected that systemic availability after ingestion is higher because the organic metal salt is dissolved in the acidic environment of the stomach. Overall, the no-effect level for systemic dermal exposure is probably higher than the DNEL that can be derived from the available data.