Registration Dossier
Registration Dossier
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EC number: 201-251-0 | CAS number: 80-10-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.39 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: based on EU OEL of HCl
- Overall assessment factor (AF):
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.39 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: based on EU OEL of HCl
- Overall assessment factor (AF):
- 1
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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
There are no adequate data regarding the repeated dose toxicity of dichloro(diphenyl)silane or its hydrolysis product diphenylsilanediol, therefore data from the other hydrolysis product HCl is considered appropriate to determine local DNELs for the parent substance. Dichloro(diphenyl)silane hydrolyses very rapidly (half-live of 10 seconds at pH 7) in contact with moist air and in contact with tissues to form 2 moles of hydrogen chloride (HCl) and one mole of diphenylsilanediol. Local effects (corrosion) are therefore influenced by the formation of HCl.
Long-term exposure –Local effects:
Inhalation DNEL:
Since each mole of dichloro(diphenyl)silane (molecular weight 253.19) produces two moles of HCl (molecular weight 36.46), it is appropriate to calculate the starting concentration of dichloro(diphenyl)silane that would result in an exposure concentration of 8 mg/m3 HCl, assuming complete hydrolysis.
The equivalent exposure level expressed as parent dichloro(diphenyl)silane is calculated as:
MW (HCl) = 36.46 g/mol
MW dichloro(diphenyl)silane = 253.19 g/mol
Amount HCl produced by 1 mole dichloro(diphenyl)silane = 2 x 36.46 g/mol = 68.92 g. Concentration of dichloro(diphenyl)silane required to produce 8 mg/m3 HCl = (253.19/68.92)*8 = 29.39 mg/m³.
No additional assessment factors are applied to the OEL.
Dermal DNEL:
The RMMs in place due to the corrosivity of the substance will prevent dermal exposure.
Inhalation DNEL (Long-term exposure - local effects, worker): 29.39 mg/m3
Long term exposure – Systemic effects
Because of the corrosivity of the substance, the DNEL for local effects is considered sufficiently protective against potential systemic effects.
Hydrogen chloride (HCl)
An EU long-term inhalation Occupational Exposure Limit (OEL) has been set for HCl as 8 mg/m3 (8 h TWA) in Commission Directive2000/39/EC.
The SIDS Initial Assessment Report (SIAR) for HCl describes a systemic NOAEL of 20 ppm from a 90-day repeated dose inhalation study (OECD, 2002). However, since the NOAEL for local effects in the same study was 10 ppm it is considered by the author of this CSR that the observed effects at 20 ppm were secondary to corrosion.
It is therefore considered appropriate to use the existing EU OEL for HCl as the starting point to quantify local DNELs for dichloro(diphenyl)silane.
General Population - Hazard via inhalation 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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local 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:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local 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:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral 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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
There is no potential for exposure of consumers via any route to dichloro(diphenyl)silane, therefore DNELs for consumers are not calculated.
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