Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

It is considered not to be either ethical or technically feasible to perform repeated dose toxicity testing with [2-(perfluorohexyl)ethyl]trichlorosilane by any route of exposure due to its known corrosive properties. Following repeated oral dosing, the corrosive nature of the product could affect the lining of the stomach, giving rise to hyperplasia and a subsequent reduced food intake. This would confound the interpretation of any systemically driven effects. A guideline-compliant repeated-dose inhalation study should elicit systemic toxicity at the highest test concentration. Since the local corrosive effects of [2-(perfluorohexyl)ethyl]trichlorosilane would be significant, a valid inhalation study according to the relevant guidelines, is technically unfeasible to do. It is also unlikely that any systemic effects would be seen at dose levels made sufficiently low (< 10 ppm) to prevent the known corrosive effects and/or distress in the test species. This has been confirmed in a 28-day inhalation study with another chlorosilane, dichloro(dimethyl)silane (WIL, 2014), in which there were no effects of treatment on clinical signs, body weight or food consumption that would indicate a systemic effect. Furthermore, the histopathology in the study indicated that the local effects in the upper respiratory tract were similar to HCl. It is therefore concluded that local effects caused by HCl will dominate the inhalation toxicity profile of [2-(perfluorohexyl)ethyl]trichlorosilane. With regard to the dermal and inhalation routes, due to the known corrosive effects of [2-(perfluorohexyl)ethyl]trichlorosilane, appropriate H-phrases and P-statements are included in the labelling, meaning that repeated skin and inhalation exposure is not expected. Any accidental skin contact or inhalation exposure could cause severe local effects but would be unlikely to cause any systemic effects.

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Assessment based on the IOEL for hydrogen chloride (8 mg/m³ (8 h TWA) in Commission Directive 2000/39/EC).
Overall assessment factor (AF):
1
Dose descriptor:
other: IOEL
AF for dose response relationship:
1
Justification:
Not required as assessment based on long term OEL.
AF for differences in duration of exposure:
1
Justification:
Not required as assessment based on long term OEL.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required as assessment based on long term OEL.
AF for other interspecies differences:
1
Justification:
Not required as assessment based on long term OEL.
AF for intraspecies differences:
1
Justification:
Not required as assessment based on long term OEL.
AF for the quality of the whole database:
1
Justification:
Not required as assessment based on long term OEL.
AF for remaining uncertainties:
1
Justification:
Not required as assessment based on long term OEL.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
66 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Assessment based on the short-term IOEL for hydrogen chloride (15 mg/m³ (15 min TWA) in Commission Directive 2000/39/EC).
Overall assessment factor (AF):
1
AF for dose response relationship:
1
Justification:
Not required as assessment based on short term OEL.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required as assessment based on short term OEL.
AF for other interspecies differences:
1
Justification:
Not required as assessment based on short term OEL.
AF for intraspecies differences:
1
Justification:
Not required as assessment based on short term OEL.
AF for the quality of the whole database:
1
Justification:
Not required as assessment based on short term OEL.
AF for remaining uncertainties:
1
Justification:
Not required as assessment based on short term OEL.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

There is no potential for exposure of general population to [2-(perfluorohexyl)ethyl]trichlorosilane via any route, therefore DNELs are not calculated.