Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
230 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
406 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the inhalation route is determined on the basis of route-to-route extrapolation from the oral 90-day study.

In this study the NOAEL was 230 mg/kg bw/day, expressed as dicyclopentyldimethoxysilane. No molecular weight correction is applied for read-across to cyclohexyldimethoxymethylsilane. The following correction was made to the NOAEL(oral) to derive the NOAEC (inhalation): Correction for respiratory rate and volume (rat to human worker): (6.7 m3/d/10 m3/d)*(1/0.38 m3/kg) (default). Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: [230 mg/kg bw/day*(6.7 m3/d /10 m3/d)*(1/0.38 m3/kg)] = 406 mg/m3.

AF for dose response relationship:
1
Justification:
A clear NOAEL has been determined.
AF for differences in duration of exposure:
2
Justification:
default sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
DNEL (Derived No Effect Level)
Value:
2.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
230 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
230 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 oral 90-day study. In this study a NOAEL of 230 mg/kg bw/day (7 days/week) was derived, expressed as dicyclopentyldimethoxysilane. No molecular weight correction is applied for read-across to cyclohexyl(dimethoxy)methylsilane. NOAEL = 230 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL has been determined
AF for differences in duration of exposure:
2
Justification:
default sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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:
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

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:
1.15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
230 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
230 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 using the key oral 90-day study on dicyclopentylsilanediol.

In this study a NOAEL of 230 mg/kg bw/day (7 days/week) was derived, expressed as dicyclopentylsilanediol. No molecular weight correction is applied for read-across to cyclohexyl(dimethoxy)methylsilane or cyclohexylmethylsilanediol.

NOAEL = 230 mg/kg bw/day

No correction was made to the NOAEL.

AF for dose response relationship:
1
Justification:
A clear NOAEL has been determined
AF for differences in duration of exposure:
2
Justification:
default subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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

Although no oral exposure will occur during normal handling and use, an oral DNEL for the general population is calculated for the purpose of assessing exposure of man via the environment.