Registration Dossier
Registration Dossier
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EC number: 206-585-0 | CAS number: 355-42-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.73 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 14.67 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Body weight 70 kg
Table R.8 -2: worker 8h exercise : 10 m3/person
Table R.8-5 : subacute to chronic: AF=6
/4 (allometric) * 70kg / 10 m3/ person
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R.8-2: rat to human
- AF for other interspecies differences:
- 1
- Justification:
- no metabolization expected
- AF for intraspecies differences:
- 5
- Justification:
- Table R8-6 workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP or NDA, validated by US-FDA data
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Dose descriptor starting point:
- NOAEC
- Justification:
- Conservative choice: systemic exposure expected to be negligible due to rapid eliminination in exhaled air.
- AF for the quality of the whole database:
- 1
- Justification:
- NDA data audited and validated by US-FDA
- AF for remaining uncertainties:
- 1
- Justification:
- systemic exposure expected to be negligible.
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:
- 50 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):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- AF for differences in duration of exposure:
- 2
- Justification:
- NOAEL obtained in a 28 d study.
- AF for interspecies differences (allometric scaling):
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.73 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
inhalation rate, light exercise (RIVM ConsExpo Web, version 1.0.6, 13-02-2019) = 1.25 m3/h
Working day = 1h chosen as worst case: no exposure foreseen for general population
Total volume inhaled = 1.25 m3
Body weight = 70 kg
50 mg/kg/d corresponds to 3500 mg, to be inhaled through 20 m3
General population chronic inhalation NAEC = 175 mg/m3
- AF for differences in duration of exposure:
- 6
- Justification:
- R8-6 subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- R.8-2 rat to human
- AF for intraspecies differences:
- 10
- Justification:
- Table R.8-19
- AF for the quality of the whole database:
- 1
- Justification:
- GLP and FDA validated data
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No toxicity was observed in acute toxicity studies.
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No adverse effect observed in acute toxicity studies.
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:
- 250 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- AF for differences in duration of exposure:
- 1
- Justification:
- General population is not expected to be exposed to tetradecafluorohexane.
- AF for interspecies differences (allometric scaling):
- 5
- Justification:
- As tetradecafluorohexane is eliminated rapidly due to high volatility, no significant systemic exposure is expected.
an AF 5 is set as a very conservative value - AF for intraspecies differences:
- 1
- Justification:
- As tetradecafluorohexane is eliminated rapidly due to high volatility, no significant systemic exposure is expected without influence of the differences of metabolism.
- AF for the quality of the whole database:
- 1
- Justification:
- Data from NDA dossier audited and validated by US-FDA.
- AF for remaining uncertainties:
- 1
- Justification:
- As the adverse effects were observed after administration of tetradecafluorohexane by IV route, associated with a galenic designed to dramatically enhance systemic exposure, their relevance for oral exposure is expected to be a very conservative hypothesis. therfore, remaining uncertainties are considered already taken into account.
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
No exposure expected for the general population.
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