Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
102 mg/m³
Most sensitive endpoint:
effect on fertility
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:
2 554 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 extrapolation of reproductive effects noted in the inhalation combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Test Guideline 422) study with the structural analogue decamethyltetrasiloxane (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. The following correction was made to the NOAEC (inhalation): Correction for exposure duration: 6 h/8 h (default for workers). Correction for respiratory rate and volume (human worker): (6.7 m³/d/10 m³/d) (default) Therefore the corrected NOAEC is: 5083*(6/8)*(6.7 m3/d /10 m³/d) = 2554 mg/m³.

AF for dose response relationship:
1
Justification:
A clear NOAEC was established
AF for differences in duration of exposure:
1
Justification:
Not required as developmental toxicity is not duration-specific
AF for interspecies differences (allometric scaling):
1
Justification:
Default (inhalation route)
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:
Guideline, GLP study
AF for remaining uncertainties:
2
Justification:
Additional assessment factor for use of screening data
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:
1 449 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
144 866 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 developmental effects noted in the inhalation combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Test Guideline 422) study with the structural analogue decamethyltetrasiloxane (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) to derive a NOAEL (dermal): Correction for exposure duration: 6h / 8h (default for workers) Correction for respiratory volume: 0.38 m³/kg (default, rat, 8 hour). Correction for dermal penetration: based on read-across from decamethyltetrasiloxane (CAS 141-62-8) dermal penetration is approximately 0.03%, therefore a conservative value of 1% is used. Therefore, the corrected NOAEL via the dermal route is: 5083*(6/8)*0.38*(100/1) = 144866 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
A clear NOAEC was established
AF for differences in duration of exposure:
1
Justification:
Not required as developmental toxicity is not duration-specific
AF for interspecies differences (allometric scaling):
4
Justification:
Default
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:
Guideline, GLP study
AF for remaining uncertainties:
2
Justification:
Additional assessment factor for use of screening data
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 mg/m³
Most sensitive endpoint:
effect on fertility
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 for systemic effects via the inhalation route is determined on the basis of route-to-route extrapolation of developmental effects noted in the inhalation combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Test Guideline 422) study with the structural analogue decamethyltetrasiloxane (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 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:
A clear NOAEC was established
AF for differences in duration of exposure:
1
Justification:
Not required as developmental toxicity is not duration-specific
AF for interspecies differences (allometric scaling):
1
Justification:
Default (inhalation)
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:
Guideline, GLP study
AF for remaining uncertainties:
2
Justification:
Additional assessment factor for use of screening data
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:
731 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
146 136 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 developmental effects noted in the inhalation combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Test Guideline 422) study with the structural analogue decamethyltetrasiloxane (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) to derive a NOAEL (dermal): Correction for exposure duration: 6h / 24h (default for workers) Correction for respiratory volume: 1.15 m³/kg (default, rat). Correction for dermal penetration: based on read-across from decamethyltetrasiloxane (CAS 141-62-8) dermal penetration is approximately 0.03%, therefore a conservative value of 1% is used. Therefore, the corrected NOAEL for the dermal route is: 5083*(6/24)*1.15*(100/1) = 146136 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
A clear NOAEC was established
AF for differences in duration of exposure:
1
Justification:
Not required as developmental toxicity is not duration-specific
AF for interspecies differences (allometric scaling):
4
Justification:
Default
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:
Guideline, GLP study
AF for remaining uncertainties:
2
Justification:
Additional assessment factor for use of screening data
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:
no hazard identified
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