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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.35 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
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL for Reactive Red 280 was found to be 200 mg/kg bw/day in a 28-day repeated dose oral toxicity study. This was used to arrive at the modified NOAEC using route to route extrapolation.

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Extrapolation to chronic exposure based on a sub-acute toxicity study
AF for interspecies differences (allometric scaling):
1
Justification:
Extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements.
AF for other interspecies differences:
1
Justification:
Default factor
AF for intraspecies differences:
5
Justification:
Default assessment factor for workers
AF for the quality of the whole database:
1
Justification:
High quality study
AF for remaining uncertainties:
2.5
Justification:
Default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.67 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
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Currently no repeated dose dermal toxicity study is available to assess the hazards via dermal route. Hence, the dose descriptor starting point was chosen to be 200 mg/kg bw/day from a 28 days repeated dose oral toxicity study. Since only a sub-acute oral toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal route. The starting point is converted to dermal NOAEL for humans by correcting for differences in absorption between routes as well as for differences in dermal absorption between rats and humans. Based on exposure model from ATG Textilien des Bundesinstituts fur Risikobewertung (BfR), the dermal penetration rate for dyes through the skin was found to be less than 2 %. However, 10 % absorption was taken into as worst case for the oral to dermal route to route extrapolation. Therefore the modified dose descriptor starting point is 2000 mg/kg bw/day. Corrected dermal NOAEL humans = oral NOAEL * ABSORPTION oral rabbit / ABSORPTION dermal human = 200 * 10 = 2000 mg/kg bw/day

AF for dose response relationship:
1
Justification:
NOAEL is available
AF for differences in duration of exposure:
6
Justification:
Extrapolation to chronic exposure based on a sub-acute toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor for allometric scaling in case of rat to human extrapolation.
AF for other interspecies differences:
1
Justification:
Default assessment factor
AF for intraspecies differences:
5
Justification:
Default assessment factor for workers
AF for the quality of the whole database:
1
Justification:
High quality study
AF for remaining uncertainties:
2.5
Justification:
Default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
580 µg/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
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
87 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL for Reactive Red 280 was found to be 200 mg/kg bw/day in a 28-day repeated dose oral toxicity study. This was used to arrive at the modified NOAEC using route to route extrapolation.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Extrapolation to chronic exposure based on a sub-acute toxicity study
AF for interspecies differences (allometric scaling):
1
Justification:
Extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements.
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default assessment factor
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
2.5
Justification:
Default assessment factor
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:
3.33 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
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Currently no repeated dose dermal toxicity study is available to assess the hazards via dermal route. Hence, the dose descriptor starting point was chosen to be 200 mg/kg bw/day from a 28 days repeated dose oral toxicity study. Since only a sub-acute oral toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal route. The starting point is converted to dermal NOAEL for humans by correcting for differences in absorption between routes as well as for differences in dermal absorption between rats and humans. Based on exposure model from ATG Textilien des Bundesinstituts fur Risikobewertung (BfR), the dermal penetration rate for dyes through the skin was found to be less than 2 %. However, 10 % absorption was taken into as worst case for the oral to dermal route to route extrapolation. Therefore the modified dose descriptor starting point is 2000 mg/kg bw/day. Corrected dermal NOAEL humans = oral NOAEL * ABSORPTION oral rabbit / ABSORPTION dermal human = 200 * 10 = 2000 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Extrapolation to chronic exposure based on a sub-acute toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor for allometric scaling in case of rat to human extrapolation.
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default assessment factor
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
2.5
Justification:
Default assessment factor
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:
333 µg/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
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL for Reactive Red 278 was found to be 200 mg/kg bw/day in a 28-day repeated dose oral toxicity study.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Extrapolation to chronic exposure based on a sub-acute toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor for allometric scaling in case of rat to human extrapolation.
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default assessment factor
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
2.5
Justification:
Default assessment factor
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