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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.88 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:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
216 mg/m³
Explanation for the modification of the dose descriptor starting point:

Currently no repeated dose inhalation toxicity study is available to assess the hazards via inhalation route. Hence, the dose descriptor starting point was chosen to be 175 mg/kg bw/day from an OECD 422 study. Since only a sub-acute oral toxicity study is available, a route-to-route extrapolation is needed to derive the DNELs for inhalation route. The starting point is converted to inhalation NOAEC for humans by correcting for differences in absorption between routes as well as for differences in inhalation absorption between rats and humans.

The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 2 in case of oral to inhalation extrapolation. Standard respiratory volume of a rat, corrected for 8 h exposure, as proposed in the REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) is considered to be 0.38 m³/kg bw. Correction for activity driven differences of respiratory volumes in workers compared to workers in rest was considered to be 6.7 m³/10 m³. Therefore the modified dose descriptor starting point is 216 mg/m³.

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable as it is already considered in the dose conversion from oral to inhalation
AF for other interspecies differences:
2.5
Justification:
As recommended by ECHA guidance R.8
AF for intraspecies differences:
5
Justification:
For workers, as recommended by ECHA guidance R.8
AF for the quality of the whole database:
1
Justification:
The study is a GLP study
AF for remaining uncertainties:
1
Justification:
Not required
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:
14.58 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:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
4 375 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 175 mg/kg bw/day from an OECD 422 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 AG Textilien des Bundesinstituts fur Risikobewertung (BfR), the dermal penetration rate for dyes through the skin was found to be less than 2 %. However, a factor of 25 was taken into consideration as worst case for the oral to dermal route to route extrapolation. Therefore, the modified dose descriptor starting point is 4375 mg/kg bw/day.

Corrected dermal NOAEL humans = oral NOAEL * ABSORPTION oral rabbit / ABSORPTION dermal human = 175 * 25 = 4375 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rats to humans
AF for other interspecies differences:
2.5
Justification:
Remaining differences
AF for intraspecies differences:
5
Justification:
Worker population
AF for the quality of the whole database:
1
Justification:
The study is GLP compliant
AF for remaining uncertainties:
1
Justification:
Not required
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:
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:
0.51 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
Dose descriptor starting point:
NOAEL
Value:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
76.09 mg/m³
Explanation for the modification of the dose descriptor starting point:

The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 2 in case of oral to inhalation extrapolation. Standard respiratory volume of a rat, corrected for 24 h exposure, as proposed in the REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) is considered to be 1.15 m³/kg bw. Therefore, the modified dose descriptor starting point is 76.09 mg/m³ (= 175 / 2 / 1.15 ).

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
The dose descriptor starting point is from a subacute toxicity, hence an AF of 6 is required from subacute to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required as the allometric scaling is already accounted in dose descriptor conversion from oral to inhalation.
AF for other interspecies differences:
2.5
Justification:
As recommended by ECHA guidance R.8.
AF for intraspecies differences:
10
Justification:
For general population, as recommended by ECHA guidance R.8
AF for the quality of the whole database:
1
Justification:
The dose descriptor is from a GLP study
AF for remaining uncertainties:
1
Justification:
Not required
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:
7.29 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:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
4 375 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 inhalation route. Hence, the dose descriptor starting point was chosen to be 175 mg/kg bw/day from an OECD 422 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 AG Textilien des Bundesinstituts fur Risikobewertung (BfR), the dermal penetration rate for dyes through the skin was found to be less than 2 %. however a factor of 25 was taken into consideration as worst case for the oral to dermal route to route extrapolation. Therefore the modified dose descriptor starting point is 4375 mg/kg bw/day.

Corrected dermal NOAEL humans = oral NOAEL * ABSORPTION oral rabbit / ABSORPTION dermal human

= 175 * 25 = 4375 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
As recommended by ECHA guidance R.8
AF for other interspecies differences:
2.5
Justification:
As recommended by ECHA guidance R.8
AF for intraspecies differences:
10
Justification:
General population, as recommended by ECHA guidance R.8
AF for the quality of the whole database:
1
Justification:
GLP study
AF for remaining uncertainties:
1
Justification:
Not required
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:
0.29 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:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
175 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The dose descriptor starting point was chosen to be 175 mg/kg bw/day from an OECD 422 study.

AF for dose response relationship:
1
Justification:
The dose descriptor is a NOAEL
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:
Assessment factor for allometric scaling from rats to humans
AF for other interspecies differences:
2.5
Justification:
Remaining differences
AF for intraspecies differences:
10
Justification:
For general population, as recommended by ECHA guidance R.8
AF for the quality of the whole database:
1
Justification:
GLP study
AF for remaining uncertainties:
1
Justification:
Not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population