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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.2 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
14.1 mg/m³
Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the inhalation route is derived from the rat 28-day oral study in which the NOAEL was 8 mg/kg/day. 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: [8 mg/kg/day*(6.7 m3/d /10 m3/d) *(1/0.38 m3/kg) ] = 14.1 mg/m3.
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Default (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (oral to inhaled)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default (workers)
AF for the quality of the whole database:
1
Justification:
Default (OECD guideline study)
AF for remaining uncertainties:
1
Justification:
Default (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:
0.03 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the dermal route is derived from the rat 28-day oral study in which the NOAEL was 8 mg/kg/day.
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Default (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default (workers)
AF for the quality of the whole database:
1
Justification:
Default (OECD guideline study)
AF for remaining uncertainties:
1
Justification:
Default (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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

An OECD 407 28-day repeated dose oral toxicity study has been conducted with 1,6-bis(trimethoxysilyl)hexane. The NOAEL was identified as the lowest dose of 8 mg/kg/day. An OECD 422 Combined 28-day repeated dose toxicity test / reproduction / developmental toxicity screening test has also been conducted via the oral route. No NOAEL was identified in this study; the LOAEL was the lowest dose, 30 mg/kg/day. Between the studies, the urinary bladder, kidneys, liver and stomach were identified as target organs.

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:
0.013 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
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 derived from the rat 28-day oral study in which the NOAEL was 8 mg/kg/day. Correction for route to route rat to human: 4 (ECHA default). Therefore the corrected NOAEL for repeated-dose systemic effects via the oral route is: 8 mg/kg/day/4 = 2 mg/kg/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Default (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (rat to 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 (OECD guideline study)
AF for remaining uncertainties:
1
Justification:
Default (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

There are no consumer applications of 1,6 -(bis(trimethoxysilyl)hexane therefore DNELs for the inhalation and dermal routes are not required. A DNEL for the oral route is calculated for the purposes of assessing exposure to humans via the environment.