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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
23.5 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:
No NOAEC from inhalation study is available. Thus, NOAEL from rat oral reproduction/fertility study is used to derive DNEL (see discussion).
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:
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Worker-Systemic-Long term effects - Inhalation

NOAEL from rat oral reproduction/fertility study is used to derive DNEL.

Relevant dose descriptor for the endpoint

NOAEL = 1 000 mg/kg bw/day Pigment Yellow 191; reproduction / developmental toxicity screening test (OECD 421), oral gavage, rat by Valaskova, 2011

Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 3.

100% oral absorption regardless of species

100% inhalation absorption regardless of species

 

Corrected inhalatory NOAEC = oral NOAEL * (1/ sRV rat 8h) * (ABS oral-rat / ABS inh-human) * (sRV human / wRV)

ABS - absorption

sRV human - respiratory volume under standard conditions

wRV - respiratory volume light activity for worker

 

Corrected inhalatory NOAEC= 1000 * (1/0.38) * (100/100) * (6.7 / 10)

Corrected inhalatory NOAEC = 1763 mg/m3

Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health

Interspecies - remaining differences 2.5

Intraspecies differences for workers 5

Exposure duration - subacute to chronic 6

Issues related to dose responses - the starting point for the DNEL calculation is a corrected NOAEC - default assessment factor 1

Quality of whole database - default assessment factor 1

Overall AF = 2.5 * 5 * 6 * 1 * 1 = 75

 

DNEL worker inhalation= 1763 mg/m3/ 75 = 23,5 mg/m3

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:
DNEL (Derived No Effect Level)
Value:
1.7 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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
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

General Population - Systemic-Long term effects - Oral

NOAEL from rat oral repeated toxicity study is used to derive DNEL.

Relevant dose descriptor for the endpoint

NOAEL = 1 000 mg/kg bw/day Pigment Yellow 191; repeated dose toxicity (OECD 407), oral gavage, rat

Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 2.

100% oral absorption regardless of species

Corrected oral NOAEL = oral NOAEL * (ABS oral-rat / ABS oral-human)

Corrected oral NOAEL = 1 000 * (100/100)

Corrected oral NOAEL = 1 000 mg/kg bw/day

Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health

Interspecies - allometric scaling 4

Interspecies - remaining differences 2.5

Intraspecies differences - general population 10

Exposure duration - subacute to chronic 6

Issues related to dose responses - the starting point for the DNEL calculation is a corrected NOAEL - default assessment factor 1

Quality of whole database - default assessment factor 1

Overall AF = 4 * 2.5 * 10 * 6 * 1 * 1 = 600

DNEL general population by oral route = 1 000 mg/kg bw/day / 600 = 1.7 mg/kg bw/day