Registration Dossier
Registration Dossier
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EC number: 219-787-9 | CAS number: 2530-87-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation 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
DNEL related information
Workers - 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 813 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 203 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The infrequent exposure DNEL for systemic effects via the inhalation route is determined on the basis of the 90-day inhalation NOAEC for (3-chloropropyl)trimethoxysilane (813 mg/m3). The following correction was made: Correction for experimental exposure duration (6 h/d to 24 h/d): 6/24 (ECHA default). Therefore, the corrected NOAEC is: 813*(6 h/ 24 h) = 203 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Assessment factor for duration of exposure does not apply for infrequent exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (rat inhaled to human inhaled)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.35 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEC
- Value:
- 813 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 935 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The infrequent exposure DNEL for systemic effects via the dermal route is determined on the basis of the 90-day inhalation NOAEC for (3-chloropropyl)trimethoxysilane (813 mg/m3). The following correction was made: Correction respiratory volume rat (24 hour) = 1.15 m³/kg bw. Therefore, the corrected NOAEL is: 813*1.15 = 935 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Assessment factor for duration of exposure does not apply for infrequent exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (inhaled rat to dermal human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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:
- 3.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEC
- Value:
- 813 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 667.8 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 route-to-route extrapolation from the inhalation NOAEC for (3-chloropropyl)trimethoxysilane (813 mg/m3) from the 90-day study in rats.
The following corrections were made to the NOAEC (inhaled): Correction respiratory volume rat (24 hour) = 1.15 m³/kg bw. Correction for dosing frequency: 5 days/7 days. Therefore, the corrected NOAEL is: 813*1.15*(5/7) = 667.8 mg/kg/day.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (inhaled rat to oral human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
