Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
32.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
32.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
1

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Additional information - workers

No long-term toxicity data are available for triacetoxyethylsilane. The quantitative hazard assessment is therefore based on the EU IOEL for acetic acid, reported as 25 mg/m3, 8-hr TWA, in Commission Directive 91/322/EEC.

Since each mole of triacetoxyethylsilane (molecular weight 234) produces three moles of acetic acid (molecular weight 60), it is appropriate to calculate the starting concentration of triacetoxyethylsilane that would result in an exposure concentration of 25 mg/m3 acetic acid, assuming complete hydrolysis.

The equivalent exposure level expressed as parent triacetoxyethylsilane is calculated as:

MW (acetic acid) = 60 g/mol;

MW triacetoxyethylsilane = 234 g/mol;

Amount acetic acid produced by 1 mole triacetoxyethylsilane = 3*(60 g/mol) = 180 g;

Concentration of triacetoxyethylsilane required to produce 25 mg/m3 acetic acid = (234/180.)*25 = 32.5 mg/m3.

No additional assessment factors are applied to the IOEL.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
1
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The DNEL for consumers is calculated using the DNEL for workers, but correcting for differences in respiratory volumes (24 hours versus 8 hours) and applying an additional assessment factor for intraspecies differences (5 for consumers versus 3 for workers, based on ECETOC defaults[LM1] ).

DNEL (local – inhalation – consumer) = 6.5 mg/m3

 [LM1]The wording on this will have to be reviewed (or ECHA defaults used) depending on decision of H&ENV TF.