Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 408-200-3 | CAS number: 63187-91-7 FRESCOLAT MGA
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.7 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:
- 352.63 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- AF for oral-to-inhalation extrapolation = 1. Based on available toxicokinetic information, complete absorption of the substance following oral administration can be assumed. As a consequence, no assessment factor is required for oral-to-inhalation extrapolation.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not used for inhalation results
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH standard AF for intraspecies differences to workers
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 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:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Correction to NOAEL based on TK information on absorption. See below.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH standard AF for intraspecies differences to workers
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the whole database
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Description of the calculation of the NOAEC used for the worker, systemic effects, long-term DNEL for the inhalation route
NOAEL = 200 mg/kg bw/d taken from the 28d-repeated dose toxicity study in rats (oral administration).
NOAEC = NOAEL (mg/kg bw/d) * (1/0.38 m3/kg bw) * (6.7 m3/10 m3)
NOAEC = 200 * (1/0.38) * (6.7/10) = 352.63 mg/m3
Description of the calculation of the NOAEL used for the worker, systemic effects, long-term DNEL for the dermal route
NOAEL = 200 mg/kg bw/d taken from the 28d-repeated dose toxicity study in rats (oral administration).
corr. NOAEL = NOAEL (mg/kg bw/d) * Abs (oral, rat) / Abs (dermal, human)
with:
- Abs (oral, rat) = 100% according to ECHA's Guidance on Information Requirements and Chemical Safety Assessment, Section R7c.12.2.4
- Abs (dermal, human) = 80% as modeled according to the equation by Kroes (Food and Chemical Toxicology 45 (2007) 2533 -2562)
corr. NOAEL = 200*100/80 = 250 mg/kg bw/d
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.16 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:
- 173.91 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- AF for oral-to-inhalation extrapolation = 1. Based on available toxicokinetic information, complete absorption of the substance following oral administration can be assumed. As a consequence, no assessment factor is required for oral-to-inhalation extrapolation.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not used for inhalation results
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH standard AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the whole database
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.41 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:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Correction to NOAEL based on TK information on absorption. See below.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH default AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the whole database
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation. No correction on the NOAEL applied; oral absorption by rat and human are assumed to be equal.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH default AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the whole database
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
Description of the calculation of the NOAEC used for the general population, systemic effects, long-term DNEL for the inhalation route
NOAEL = 200 mg/kg bw/d taken from the 28d-repeated dose toxicity study in rats (oral administration).
NOAEC = NOAEL(mg/kg bw/d) * (1/1.15 m3/kg bw)
NOAEC = 200 * (1/1.15) = 173.91 mg/m3
Description of the calculation of the NOAEL used for the general population, systemic effects, long-term DNEL for the dermal route
NOAEL = 200 mg/kg bw/d taken from the 28d-repeated dose toxicity study in rats (oral administration).
corr. NOAEL = NOAEL (mg/kg bw/d) * Abs (oral, rat) / Abs (dermal, human)
with:
- Abs (oral, rat) = 100% according to ECHA's Guidance on Information Requirements and Chemical Safety Assessment, Section R7c.12.2.4
- Abs (dermal, human) = 80% as modeled according to the equation by Kroes (Food and Chemical Toxicology 45 (2007) 2533 -2562)
corr. NOAEL = 200*100/80 = 250 mg/kg bw/d
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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