Registration Dossier
Registration Dossier
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EC number: 220-168-0 | CAS number: 2650-18-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 88.3 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 631 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 104.25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Despite the substance is marketed in non-inhalable forms, and inhalation should not be a preferred route for absorption, DNEL values for inhalation route (workers, systemic effect) are calculated to better evaluate the risk assessment.
Original value is NOAEL 631 mg/kg bw/day, chronic toxicity in female rat by oral administration. The NOAEC is derived taking into account the allometric scaling from rat to human that is equal to 4. The result is multiplied by 70 kg considered as the average weight of a human being (bw) and divided by 10 m^3/person considered as the average volume that is breathed in an 8h exposure. In conclusion [(631 mg/kg bw/d / 4)*70 kg bw]/10 m^3/person= 1104.25 mg/m^3. This NOAEC value should be divided by the product of the following assessment factors: 1 AF for dose response relationship, 1 AF for differences in duration exposure (chronic to chronic), 1 AF for allometric scaling (allometric scaling on rat already considered), 2.5 AF for other interspecies differences, 5 AF for intraspecies differences (workers), 1 AF for the quality of the whole database, 1 AF for remaining uncertainties: 1104.25 mg/kg bw/d / 12.5 = 88.3 mg/m^3.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 17.67 mg/kg bw/day
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 631 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 883.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Original value NOAEL 631 mg/kg bw/day (chronic toxicity in female rat by oral administration) was multiplied by 1.4 (considering the correction for differences between human and experimental exposure conditions, i.e. 7 days per week (experimental)/ 5 days per week (worker population)). Starting point = 631 mg/ kg bw/day * 1.4 = 883.4 mg/ kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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 substance is a highly water soluble blue dye with a molecular weight of > 500 g/mol. It is non hazardous in chronic feeding studies in rats and mice. Available safety data support the use as an approved food colorant. The substance does not cause local effects. Physico-chemical data and experimental studies with dermal application indicate that there is very little dermal penetration and no hazard.
DNELs are calculated on the basis of a repeated dose toxicity study (oral, 30 months) that reports a NOAEL of 631 mg/kg bw/day calculated for female rats. DNELs for workers are:
INHALATION ROUTE
SYSTEMIC EFFECTS:
a) Long term: DNEL= 88.3 mg/m^3 (NOAEC= 1104.25 mg/m^3 and Overall AF= 12.5)
b) Short term: No hazard identified
LOCAL EFFECTS short and long term: No hazard identified
DERMAL ROUTE
SYSTEMIC EFFECTS:
a) LONG TERM: DNEL = 17.67 mg/kg bw/day (NOAEL modified = 883.4 mg/kg bw/d, Overall AF= 50)
b) SHORT TERM: No hazard identified
LOCAL EFFECTS short and long term: No hazard identified
HAZARD FOR EYE
LOCAL EFFECTS: no hazard identified.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 631 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 473.25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Despite the substance is marketed in non-inhalable forms, and inhalation should not be a preferred route for absorption, DNEL values for inhalation route (general population, systemic effect) are calculated to better evaluate the risk assessment.
Original value is NOAEL 631 mg/kg bw/day, chronic toxicity in female rat by oral administration. The NOAEC is derived taking into account the allometric scaling from rat to human that is equal to 4. The result is multiplied by 60 kg considered as the average weight of a human being (bw) and divided by 10 m^3/person considered as the average volume that is breathed by general population. In conclusion [(631 mg/kg bw/d / 4)*60 kg bw]/20 m^3/person= 473.25 mg/m^3. This NOAEC value should be divided by the product of the following assessment factors: 1 AF for dose response relationship, 1 AF for differences in duration exposure (chronic to chronic), 1 AF for allometric scaling (allometric scaling on rat already considered), 2.5 AF for other interspecies differences, 10 AF for intraspecies differences (workers), 1 AF for the quality of the whole database, 1 AF for remaining uncertainties: 473.25 mg/kg bw/d / 25 = 19 mg/m^3.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 6.31 mg/kg bw/day
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 631 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 2.5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 6.31 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 631 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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 substance is a highly water soluble blue dye with a molecular weight of > 500 g/mol. It is non hazardous in chronic feeding studies in rats and mice. Available safety data support the use as an approved food colorant. The substance does not cause local effects. Physico-chemical data and experimental studies with dermal application indicate that there is very little dermal penetration and no hazard.
DNELs are calculated on the basis of a repeated dose toxicity study (oral, 30 months) that reports a NOAEL of 631 mg/kg bw/day calculated for female rats. DNELs for general population are:
INHALATION ROUTE
SYSTEMIC EFFECTS:
a) Long term: DNEL= 19.0 mg/m^3 (NOAEC= 473.25 mg/m^3 and Overall AF= 25)
b) Short term: No hazard identified
LOCAL EFFECTS short and long term: No hazard identified
DERMAL ROUTE
SYSTEMIC EFFECTS:
a) LONG TERM: DNEL = 6.31 mg/kg bw/day (Overall AF= 100)
b) SHORT TERM: No hazard identified
LOCAL EFFECTS short and long term: No hazard identified
ORAL ROUTE
SYSTEMIC EFFECTS:
a) LONG TERM: DNEL = 6.31 mg/kg bw/day (Overall AF= 100)
b) SHORT TERM: No hazard identified
LOCAL EFFECTS short and long term: No hazard identified
HAZARD FOR EYE
LOCAL EFFECTS: no hazard identified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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