Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
LOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
LOAEC

Local effects

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

Workers - Hazard via dermal route

Systemic effects

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

Workers - Hazard for the eyes

Additional information - workers

Trichloro(phenyl)silaneis a moderately volatile liquid whichhydrolyses very rapidly in moist air and in contact with tissues to form hydrogen chloride (HCl) and phenylsilanetriol. Local effects (corrosion) are therefore influenced by the formation of HCl, while systemic effects may occur following exposure to the silanol hydrolysis product.

 

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 and were not indicative of true systemic toxicity.

The OECD SIAR (2002) reports the following:

For repeated dose toxicity, 13 inhalation and 7 oral dose studies has been reported. Among those, only the inhalation studies reported by CIIT (1984) were reliable. They were performed in compliance with FDA-GLP, and they are considered to be the critical studies for assessment. Four groups of 10 males and 10 females (mice: B6C3F1; rats: SD and F344) individually housed were exposed to hydrogen chloride gas at concentrations of 0, 10, 20 and 50 ppm for 90 days (6 hours/day, 5 days/week). For male and female mice at 50 ppm, a decrease in body weight gain, food consumption and liver weight (male) was noted. For male SD rats at 50 ppm, a decrease in food consumption was observed. For F344 rats, a decrease in body weight gain was observed in males at 50 ppm and a decrease in food consumption was observed in both sexes at 20 and 50 ppm. No biologically significant difference was observed in urinalysis, haematology and serum chemistry. Inflammatory histopathological changes in lips or nasal cavity were observed in B6C3F1 mice and F344 rats above 10 ppm or in SD rats above 20 ppm. In addition, the histopathological examination of reproductive organs (testis, epididymis, prostate, seminal vesicle; ovary, uterus, oviduct, mammary glands) could not find any exposure related effects. The NOAEL for repeated dose inhalation toxicity, except for the local effects of irritation, is considered to be 20 ppm for rats and mice.

It is therefore considered appropriate to use the existing EU OEL for HCl as the starting point to quantify local DNELs for trichloro(phenyl)silane.

Typical worker exposure involveslow levels of exposure on a repeated basis (below the OEL for HCl). Any exposure will result in hydrolysis to silanol, hydrogen ions and chloride ions; the ions will enter the body's natural buffering and homeostatic processes independently of the silanol.The silanol hydrolysis product must therefore be considered for systemic DNELs because it is expected that this substance will be systemically available. This might be particularly important in situations when inhalation occurs and HCl is neutralised before it reaches the lower respiratory tract, so the silanol hydrolysis product is available for absorption, but there is no irritation from which secondary effects could arise. Also, a systemic DNEL based on the silanol must be considered to allow for situations when the exposure to the silanol is below the local DNEL, but could still cause systemic effects.

Trichloro(phenyl)silane (read-across from trimethoxy(phenyl)silane

There are no repeated dose toxicity data on trichloro(phenyl)silane or its hydrolysis product, phenylsilanetriol, so good quality data for the read-across substance trimethoxy(phenyl)silane (CAS 2996-92-1) has been used to assess the general systemic toxicity of trichloro(phenyl)silane.No read-across data are available for the dermal or inhalation route.Local effects from the other hydrolysis product (HCl) are not addressed by these data on trimethoxy(phenyl)silane.

A well reported oral OECD 422 study (Harlan, 2009), conducted according to the current guideline and in accordance with GLP, did not identify an NOAEL for trimethoxy(phenyl)silane; effects on the urinary bladder were reported at the lowest tested dose of 100 mg/kg bw/day. Dosing was performed on 7 days per week.

There are no reproductive or developmental toxicity data on trichloro(phenyl)silane or its hydrolysis product, phenylsilanetriol, so good quality data for the related substance trimethoxy(phenyl)silane has been used to assess the reproductive and developmental toxicity of trichloro(phenyl)silane. Local effects from the other hydrolysis product (HCl) are not addressed by these data.

In the OECD 422 study conducted by Harlan (2009), no adverse effects on reproduction or developmental effects were observed up to the highest tested dose of 500 mg/kg bw/day trimethoxy(phenyl)silane. General systemic parental effects were reported at the lowest tested dose of 100 mg/kg bw/day.

In the absence of any findings relating to reproductive or developmental endpoints in appropriate screening tests, the critical health effect is considered to be repeated dose toxicity. Trichloro(phenyl)silaneis not classified as mutagenic, carcinogenic or sensitising.

The DNELs used for risk characterisation are therefore:

DNEL (long-term, inhalation): 3.3 mg/m3

DNEL (long-term, dermal): 0.46 mg/kg/day

Qualitative risk characterisation for corrosive effects following dermal exposure will also be required.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

There is no potential for exposure of consumers via any route to trichloro(phenyl)silane, therefore DNELs for consumers are not calculated.