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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 243-053-7 | CAS number: 19430-93-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 67.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10 122 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- inhalation to inhalation
- AF for dose response relationship:
- 1
- Justification:
- a NOAEC is observed
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling per REACH
- AF for other interspecies differences:
- 2.5
- Justification:
- Default toxicodynamic differences REACH Guidance (R 8.4.3.1)
- AF for intraspecies differences:
- 5
- Justification:
- A default assessment factor for workers proposed in the REACH Guidance (R 8.4.3.1)
- AF for the quality of the whole database:
- 2
- Justification:
- Developmental toxicity data available but no fertility data. No two-generation reproductive toxicity study.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factor judged necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Workers
According to the REACH "Guidance on information requirements and chemical safety assessment" , a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible. The oral and dermal routes of exposure are considered to be unlikely routes of exposure for PFBE, therefore no DNELs were derived for these routes. The substance is not classified for acute toxicity, and according to REACH "Guidance on information requirements and chemical safety assessment" (R.8.4.3.1), no acute/short term exposure DNELs need to be derived.
A DNEL for PFBE can be derived using the clear NOAEC of 20123 mg/m3 (2000 ppm) demonstrated in the 28-day repeat dose toxicity study in the rat.
PFBE Table A. Calculation of DNEL for long-term exposure - systemic effects in workers is derived as follows:
Description |
Value |
Remark |
Relevant dose descriptor |
Corrected NOAEC 10112 mg/m3 (1005 ppm) |
Correct for respiratory volume (from resting rat to active human): 6.7 m3/10m3 = 0.67. Correct for exposure time (from 6 hour rat to 8 hour human): 6/8 = 0.75 Corrected NOAEC = 20123 x 0.67 x 0.75 = 10112 mg/m3 (1005 ppm) |
Route to route extrapolation |
1 |
Inhalation to inhalation |
Scaling factor animal to man |
1 |
No allometric scaling per REACH R.8.4.3.1 |
Other interspecies differences |
2.5 |
Default toxicodynamic differences REACH Guidance R8. Appendix 3 |
Intraspecies variability |
5 |
A default assessment factor for workers, as proposed in the REACH Guidance (R 8.4.3.1) |
Exposure duration |
6 |
Sub-acute to chronic. A default assessment factor. REACH Guidance R8. Appendix 3. Also see Reference (a) |
Dose response |
1 |
A NOAEC is observed |
Quality of the database |
2 |
Developmental toxicity data but no fertility data. No two-generation reproductive toxicity study. |
DNEL |
Value |
|
For workers |
|
10112/ (1 x 1 x 2.5 x 5 x 6 x 1 x 2) =67.4 mg/m3 |
PFBE DNEL for workers (based on ECHA Guidance = 67.4 mg/m3 (6.7 ppm)
(a) Principles for deriving 'Provisional Workplace Guidance Values' (Arbeitsplatzrichtwerte, ARW) for airborne substances by the German Committee on Hazardous Substances (Ausschuss für Gefahrstoffe). Cited by Kalberlah F et al Ann. occup. Hyg., Vol 46, No.2, pp 175 - 185, 2002.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5 031 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation to inhalation
- AF for dose response relationship:
- 1
- Justification:
- A NOAEC is observed
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling per REACH 8.4.3.1
- AF for other interspecies differences:
- 2.5
- Justification:
- Default toxicodynamic differences REACH Guidance R8. Appendix 3.
- AF for intraspecies differences:
- 10
- Justification:
- A default assessment factor for the general population, as proposed in the REACH Guidance (R8.4.3.1)
- AF for the quality of the whole database:
- 2
- Justification:
- Developmental toxicity data but no fertility data. No two-generation reproductive toxicity study.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factor judged necessary
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- low hazard (no threshold derived)
Additional information - General Population
General Population
According to the REACH "Guidance on information requirements and chemical safety assessment" , a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible. The oral and dermal routes of exposure are considered to be unlikely routes of exposure for PFBE, therefore no DNELs were derived for these routes. The substance is not classified for acute toxicity, and according to REACH "Guidance on information requirements and chemical safety assessment" (R.8.4.3.1), no acute/short term exposure DNELs need to be derived.
A DNEL for PFBE can be derived using the clear NOAEC of 20123 mg/m3 (2000 ppm) demonstrated in the 28-day repeat dose toxicity study in the rat.
PFBE Table B. Calculation of DNEL for long-term exposure - systemic effects in the general population is derived as follows:
Description |
Value |
Remark |
Relevant dose descriptor |
Corrected NOAEC 5031 mg/m3 (500 ppm) |
Correct for exposure time (from 6 hour rat to 24 hour human): 6/24 = 0.25. Corrected NOAEC = 20123 x 0.25 = 5031 mg/m3 (500 ppm) |
Route to route extrapolation |
1 |
Inhalation to inhalation |
Scaling factor animal to man |
1 |
No allometric scaling per REACH R.8.4.3.1 |
Other interspecies differences |
2.5 |
Default toxicodynamic differences REACH Guidance R8. Appendix 3 |
Intraspecies variability |
10 |
A default assessment factor for the general population, as proposed in the REACH Guidance (R 8.4.3.1) |
Exposure duration |
6 |
Sub-acute to chronic. A default assessment factor. REACH Guidance R8. Appendix 3. Also see Reference (a) |
Dose response |
1 |
A NOAEC is observed |
Quality of the database |
2 |
Developmental toxicity data but no fertility data. No two-generation reproductive toxicity study. |
DNEL |
Value |
|
For general population |
|
5031 / (1 x 1 x 2.5 x 10 x 6 x 1 x 2) =16.8 mg/m3 |
PFBE DNEL for general population (based on ECHA Guidance = 16.8 mg/m3 (1.7 ppm)
(a) Principles for deriving 'Provisional Workplace Guidance Values' (Arbeitsplatzrichtwerte, ARW) for airborne substances by the German Committee on Hazardous Substances (Ausschuss für Gefahrstoffe). Cited by Kalberlah F et al Ann. occup. Hyg., Vol 46, No.2, pp 175 - 185, 2002.
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