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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:
1.12 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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:
83.75 mg/m³
Explanation for the modification of the dose descriptor starting point:
Available data do not suggest a pronounced difference between oral and inhalation route. Due to a lack of experimental data the NOAEC (corr) was derived including ECHAs recommended absorption rates for exposure via the oral (50%) and inhalation (100%) route.
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
6
Justification:
extrapolation from sub-acute to chronic (default)
AF for interspecies differences (allometric scaling):
1
Justification:
default (inhalation)
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default (worker)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
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:
0.32 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
95 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Available data do not suggest a pronounced difference between oral and dermal route. Due to a lack of experimental data the NOAEL (corr) was derived including equal absorption rates for exposure via the oral (100%) and dermal (100%) route.
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
6
Justification:
extrapolation from sub-acute to chronic (default)
AF for interspecies differences (allometric scaling):
4
Justification:
default (rat)
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default (worker)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
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:
medium hazard (no threshold derived)

Additional information - workers

The risk assessment of this substance is triggered by the effects (mortality) in repeated dose toxicity studies (28d and repro screen), acute oral, dermal and inhalation toxicity, and severe eye effects. 

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 general population does not have access to Basic Yellow 28 methyl sulfate. Considering textiles, the fixation rate of the dye is very high. Due to the strong ionic bound of the dye with the fabric, the dye has a very good fastness, and migration or evaporation of the dye from the fabric resulting in exposure of customers is not likely.

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