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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:
102 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
2 554 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL for developmental effects via the inhalation route is determined on the basis of the inhalation OECD 422 study. 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 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 for developmental effects via the inhalation route is: 5083*(6/8)*(6.7 m³/d /10 m³/d) = 2554 mg/m³.

AF for dose response relationship:
1
Justification:
A clear NOAEL 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
DNEL extrapolated from long term DNEL

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:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
144 900 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for developmental effects via the dermal route is determined on the basis of route-to-route extrapolation from the inhalation OECD 422 study. 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) 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). Therefore, the corrected NOAEL for developmental effects via the dermal route is: 5083*(6/8)*0.38 = 1449 mg/kg bw/day. In practice, dermal absorption of this substance is very limited. A further correction for the known dermal absorption of 1% has been made, with the additional factor of 100: 1449 mg/kg bw/day x 100 = 144900 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

There were no adverse effects in any of the available tests. However, since there is a data gap for developmental toxicity, which will be filled by testing, indicative DNELs are based on the current NOAEC for developmental toxicity from the screening study on decamethyltetrasiloxane for the purposes of initial risk characterisation.

Short-term high exposures are considered unlikely given the high levels of control in place at sites producing and using the substance. DNELs for long-term exposure are therefore adequate to protect against short-term exposures and no separate short-term DNELs are calculated.

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:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Explanation for the modification of the dose descriptor starting point:

The DNEL for developmental effects via the inhalation route is determined on the basis of the inhalation OECD 422 study. 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 for developmental effects via the inhalation route 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 route)
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:
730.5 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
146 100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for developmental effects via the dermal route is determined on the basis of route-to-route extrapolation from the inhalation OECD 422 study. 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 consumers) Correction for respiratory volume: 1.15 m3/kg (default, rat). Therefore, the corrected NOAEL for developmental effects via the dermal route is: 5083*(6/24)*1.15 = 1461 mg/kg bw/day. . In practice, dermal absorption of this substance is very limited. A further correction for the known dermal absorption of 1% has been made, with the additional factor of 100: 1461 mg/kg bw/day x 100 = 146100 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:
DNEL (Derived No Effect Level)
Value:
0.04 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:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Not applicable. The DNEL for exposure of man via the environment is based on the 28-day oral gavage study conducted to OECD 407, in which the NOAEL was 25 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was established
AF for differences in duration of exposure:
6
Justification:
Default (sub-acute to chronic)
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:
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