Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.2 mg/m³
Most sensitive endpoint:
effect on fertility
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.17 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Tris(2-methoxyethoxy)vinylsilane is a volatile liquid which hydrolyses rapidly in contact with water (half-life 1 hour at pH 7) to form 2-methoxyethanol (ethylene glycol) and vinylsilanetriol. Data are available for the substance itself, therefore exposure would have been to a mixture of parent material and hydrolysis products.

In a combined oral gavage OECD 422 study with tris(2-methoxyethoxy)vinylsilane in rats there were no test article-related effects on mean body weights, body weight gains or food consumption in the toxicity phase females (WIL Research, 2005).. Haematological effects were observed in both sexes in the 250 mg/kg/day toxicity phase group. These findings correlated with the microscopic finding of hypocellularity in the sternal bone marrow, in which aggregates of mature granulocytes were absent. Serum chemistry parameters in the 250 mg/kg/day toxicity phase male and female groups were observed. Test article-related macroscopic changes, microscopic changes and/or reductions in organ weights were observed in the 75 mg/kg/day group males and the 250 mg/kg/day group males and females. The NOAEL fortris(2-methoxyethoxy)vinylsilanefor male systemic toxicity is 25 mg/kg/day. Based on effects on haematology and serum chemistry parameters and effects on lymphoid tissues for females at 250 mg/kg/day, which were similar to the effects noted for males, the NOAEL for female systemic toxicity is 75 mg/kg/day.

The NOAEL for tris(2-methoxyethoxy)vinylsilane for male and female reproductive toxicity in the OECD 422 study was 25 mg/kg/day, based on decreased fertility at 250 mg/kg/day, macroscopic and microscopic changes with corresponding decreases in weights for the male reproductive organs at 250 mg/kg/day and the reduced mean litter size in the 75 mg/kg/day group.

The NOAEL for tris(2-methoxyethoxy)vinylsilane for foetotoxicity/developmental toxicity in the OECD 422 study was 75 mg/kg/day. A role for developmental toxicity in the reduced postnatal survival at this dose cannot be excluded. The NOAEL for teratogenicity is ≥75 mg/kg/day.

No reliable data are available for the dermal or inhalation routes.

No quantitative DN(M)ELs could be derived for:

Local effects (no effects)

Mutagenicity (substance is not mutagenic)

Carcinogenicity (no data)

The critical endpoint for human health fortris(2-methoxyethoxy)vinylsilaneis reproductive toxicity, based on decreased fertility, macroscopic and microscopic changes , with corresponding decreases in weights for the male reproductive organs, and reduced mean litter size.

The DNELs used for risk characterisation for workers are therefore:

DNEL (long-term, inhalation): 1.2 mg/m3

DNEL (long-term, dermal): 0.17 mg/kg/day

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.37 mg/m³
Most sensitive endpoint:
effect on fertility
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The DNELs used for risk characterisation for consumers are calculated using the same data as discusssed above for workers and are:

DNEL (long-term, inhalation): 0.37 mg/m3

DNEL (long-term, dermal): 0.10 mg/kg/day

DNEL (long-term, oral): 0.10 mg/kg/day