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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 952-252-4 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.303 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:
- 9.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 22.71 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL (oral route, subacute) = 9.2 mg/kg bw/day
Correction factor for differences in respiratory volume (rat/workers): 1/0.38
Correction factor for light activity at work: 6.7/10
Correction factor for difference between human and experimental exposure conditions: 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
Absorptions by inhalation and oral route were concluded to be equivalent (100%) for PFA.
NOAEC = NOAEL x (1/0.38) x (6.7/10) x 7/5 = 9.2 x (1/0.38) x (6.7/10) x 7/5 = 22.71 mg/m3- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
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:
- 0.072 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:
- 9.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 21.47 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL (oral route, subacute) = 9.2 mg/kg bw/day
Absorptions by the dermal route was concluded to represent 60% of the absorption following exposure via the oral route for PFA.
Correction factor for difference between human and experimental exposure conditions: 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
NOAEL = NOAEL x 100/60 x 7/5 = 9.2 x 100/60 x 7/5 = 21.47 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.053 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:
- 9.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL (oral route, subacute) = 9.2 mg/kg bw/day
Absorptions by the dermal route was concluded to represent 60% of the absorption following exposure via the oral route for PFA.
Correction factor for difference between human and experimental exposure conditions: 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
NOAEL = NOAEL x 100/60 x 7/5 = 9.2 x 100/60 x 7/5 = 8 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
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:
- 0.026 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:
- 9.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15.33 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL (oral route, subacute) = 9.2 mg/kg bw/day
Absorptions by the dermal route was concluded to represent 60% of the absorption following exposure via the oral route for PFA.
NOAEL = NOAEL x 100/60 = 9.2 x 100/60 = 15.33 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 0.015 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:
- 9.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point is required.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
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
In accordance with Regulation EC N°1272/2008, the registered substance is classified STOT RE 2; H373.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
