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Registration Dossier
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EC number: 428-480-0 | CAS number: 214559-61-2 COLORANT Y-1189; DUASYN; DYE Y-1189; FARBSTOFF Y-1189; Y-1189; Y-1189L
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 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:
- 529 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation NOAEC = 600 x (1/0.38) x (50/100) x (6.7/10) = 529 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required. Taken into account in conversion of oral to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default intraspecies factor for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL = 600 mg/kg x (50/10) = 3000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies allometric factor for extrapolating from rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default intraspecies factor for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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
The material was not acutely toxic via the oral or dermal route and is not anticipated to be acutely toxic via the inhalation route.
Two repeat dose toxicity studies are available: A 28 day repeat dose oral study in rats, and an OECD 421 oral study in rats. In absence of adverse effects in these studies, the NOAELs were set at the highest doses tested These NOAELs were 1000 mg/kg bw/day for parental, reproductive and developmental effects in the OECD 421 study (Petus – Árpásy, 2014; summarised at 7.8.1 and 7.8.2 (Dossier) / 5.9.1 (CSR)) and 600 mg/kg bw/day in an OECD 407 study (Lortie, 2002; Summarised at 7.5.1 (Dossier) / 5.6.1 (CSR)). In deriving the DNEL, the 600 mg/kg NOAEL is used as the OECD 407 study covers endpoints that the OECD 421 does not. The OECD 421 study gives an indication of an absence of reproductive findings and maternal toxicity at upto 1000 mg/kg bw/day.
The test material was not genotoxic, or toxic to reproduction in the OECD 421 study.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 261 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation NOAEC = 600 x (1/1.15) x (50/100) = 261 mg/m3/day
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required. Taken into account in conversion of oral to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- 5 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:
- 3 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL = 600 mg/kg x (50/10) = 3000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies allometric factor for extrapolating from rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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 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:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation required.
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies allometric factor for extrapolating from rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are 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
The material was not acutely toxic via the oral or dermal route and is not anticipated to be acutely toxic via the inhalation route.
Two repeat dose toxicity studies are available: A 28 day repeat dose oral study in rats, and an OECD 421 oral study in rats. In absence of adverse effects in these studies, the NOAELs were set at the highest doses tested These NOAELs were 1000 mg/kg bw/day for parental, reproductive and developmental effects in the OECD 421 study (Petus – Árpásy, 2014; summarised at 7.8.1 and 7.8.2 (Dossier) / 5.9.1 (CSR)) and 600 mg/kg bw/day in an OECD 407 study (Lortie, 2002; Summarised at 7.5.1 (Dossier) / 5.6.1 (CSR)). In deriving the DNEL, the 600 mg/kg NOAEL is used as the OECD 407 study covers endpoints that the OECD 421 does not. The OECD 421 study gives an indication of an absence of reproductive findings and maternal toxicity at upto 1000 mg/kg bw/day.
The test material was not genotoxic, or toxic to reproduction in the OECD 421 study.
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