Registration Dossier
Registration Dossier
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EC number: 200-901-0 | CAS number: 75-78-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49.4 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 617 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the inhaled route is determined on the basis of route-to route extrapolation from the OECD 414 oral study with dimethylsilanediol (DMSD). Since HCl does not contribute to the systemic toxicity of dichloro(dimethyl)silane, it is appropriate to correct the observed NOAEL for DMSD to give the starting dose of parent material that would result in administration of 250 mg/kg of DMSD. This is done as follows: NOAEL (DMSD) = 250 mg/kg/day MW (DMSD) = 92.17 MW (dichloro(dimethyl)silane) = 129.06 NOAEL (dichloro(dimethyl)silane) = 250 mg/kg/d * 129.06/92.17 = 350 mg/kg/day The following correction was made to the NOAEL (oral): Correction respiratory volume rat (8 hour) 1/0.38 m3/kg bw/day, Correction for respiratory volume (worker): 6.7 m3/10 m3. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 350 mg/kg/day*(1/0.38) *(6.7 m3/10 m3)* = 617 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (developmental effect, no duration AF needed)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49.4 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: EU OEL
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- other: 14.2 mg/m3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: EU OEL
- Overall assessment factor (AF):
- 1
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 350 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the dermal route is determined on the basis of route-to route extrapolation from the OECD 414 oral study with dimethylsilanediol (DMSD). Since HCl does not contribute to the systemic toxicity of dichloro(dimethyl)silane, it is appropriate to correct the observed NOAEL for DMSD to give the starting dose of parent material that would result in administration of 250 mg/kg of DMSD. This is done as follows: NOAEL (DMSD) = 250 mg/kg/day MW (DMSD) = 92.17 MW (dichloro(dimethyl)silane) = 129.06 NOAEL (dichloro(dimethyl)silane) = 250 mg/kg/d * 129.06/92.17 = 350 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (developmental effect, no duration AF needed)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to dermal human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (guideline study)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the inhaled route is determined on the basis of route-to route extrapolation from the OECD 414 oral study with dimethylsilanediol (DMSD). General Population exposure would be to the hydrolysis product DMSD so no conversion to corresponding dose of dichloro(dimethyl)silane required. The following correction was made to the NOAEL (oral): Correction respiratory volume rat (24 hour) 1/1.15 m3/kg bw/day. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 250 mg/kg/day*(1/1.15) = 217 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (developmental effect, no duration AF needed)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: EU OEL
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- other: 4.8
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: EU OEL
- Overall assessment factor (AF):
- 1
- DNEL extrapolated from long term DNEL
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:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the oral route is determined on the basis of the OECD 414 oral study with dimethylsilanediol (DMSD). General Population exposure would be to the hydrolysis product DMSD so no conversion to corresponding dose of dichloro(dimethyl)silane required.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (developmental effect, no duration AF needed)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to oral human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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