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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
143 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:
5 083 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
3 576 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL is determined on the basis of the inhalation 90 day study with decamethyltetrasiloxane (L4, CAS 141-63-9). In this study a NOAEC of at least 400 ppm equivalent to at least 5083 mg/m³ was derived as there were no adverse effects up to the highest dose tested. NOAEC ≥5083 mg/m³. The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (6 h/d to 8 h/d), Correction for dosing frequency (7 d/w to 5 d/w), Correction for respiratory volume (worker): 6.7 m³/10 m³. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 5083*(6 h/ 8 h)*7d/5d*(6.7 m³/10 m³) = 3576 mg/m³.

AF for dose response relationship:
1
Justification:
A clear NOAEC was established
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (inhalation rat to inhalation human)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default (worker)
AF for the quality of the whole database:
1
Justification:
Guideline, GLP study
AF for remaining uncertainties:
1
Justification:
There are 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:
20.3 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):
100
Dose descriptor starting point:
NOAEC
Value:
5 083 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
2 028 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL is determined on the basis of the inhalation 90 day study with decamethylpentasiloxane (L4, CAS 141-63-9). In this study a NOAEC of at least 400 ppm equivalent to at least 5083 mg/m³ was derived as there were no adverse effects up to the highest dose tested. NOAEC ≥5083 mg/m³.

The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (8 hour) = 0.38 m³/kg bw. Correction for duration: (6h/d to 8 h/d),Correction for dosing frequency (7 d/w to 5 d/w). Therefore the corrected NOAEL for repeat-dose systemic effects via the oral route is:5083*0.38*(6/8)*(7/5) = 2028 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
Default (NOAEL)
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
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 (worker)
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
There are 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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25.4 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):
50
Dose descriptor starting point:
NOAEC
Value:
5 083 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1 271 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL is determined on the basis of the inhalation 90 day study with decamethylpentasiloxane (L4, CAS 141-63-9). In this study a NOAEC of at least 5083 mg/m³ was derived as there were no adverse effects up to the highest dose tested. NOAEC ≥5083mg/m³. The following correction was made to the NOAEC (inhalation): Correction for exposure duration: 6/24 (default for consumers). Therefore the corrected NOAEC is: 5083 mg/m³*(6/24) = 1271 mg/m³.

AF for dose response relationship:
1
Justification:
Default (NOAEC)
AF for differences in duration of exposure:
2
Justification:
Default (subchrinic to subchronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (inhalation rat to inhalation 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:
There are 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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
29.2 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:
5 083 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
5 845 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 of the inhalation 90 day study with decamethyltetrasiloxane (L4, CAS 141-62-8). In this study a NOAEC of at least 5083 mg/m³ was derived as there were no adverse effects up to the highest dose tested. NOAEC ≥5083 mg/m³. The following correction was made to the NOAEC (inhalation): Correction respiratory volume rat (24 hour) = 1.15 m³/kg bw. Therefore the corrected NOAEL for repeat-dose systemic effects via the oral route is: 5083*1.15 = 5845

AF for dose response relationship:
1
Justification:
Default (NOAEL)
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (inhalation 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:
Guideline, GLP study
AF for remaining uncertainties:
1
Justification:
There are 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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 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:
1 000 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 oral OECD 407 study with dodecamethylpentasiloxane (L5, CAS 141-63-9). No correction required for oral rat to oral human.

AF for dose response relationship:
1
Justification:
A clear NOAEC was established.
AF for differences in duration of exposure:
6
Justification:
Default (subacute to subchronic)
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 (General population)
AF for the quality of the whole database:
1
Justification:
Guideline, GLP study
AF for remaining uncertainties:
1
Justification:
There are 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