Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 402-580-4 | CAS number: 111439-76-0 ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose the default respiratory volume for the rat corresponding to the daily duration of human exposure is considered in the first step, followed by a correction for the difference between respiratory rates of workers under standard conditions and under light activity in the second step. NAECcorr_inh = oral NOAEL (1000) x 1/0.38 m3/kg bw x 6.7 m3/10 m3 = 1763.2 mg/m3. Oral absorption in rats in humans is assumed to be 100% and inhalation absorption in humans is assumed to be 100%. Therefore, NAECcorr_inh = 1763.2 x 1 = 1763.2 mg/m3.
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- No allometric scaling required for inhalation route.
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor for good quality database, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.7 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 1 114 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Not required
- Justification:
- Default factor when starting point is LOAEC, in accordance with REACH Guidance R.8
- Justification:
- No allometric scaling required for inhalation route.
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor for good quality database, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
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:
- 3.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assuming that oral absorption in rats is 100% and that dermal absorption in humans is 100%. Therefore dose descriptor after route to route extrapolation is 1000 x 100/100 = 1000 mg/kg bw/day.
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- Default factor (rat to human), in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
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)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The substance is classified as a category 2 skin irritant, however, no dose response data are available therefore a qualitative risk assessment has been conducted. An acute systemic dermal DNEL was not derived because the substance is not classified for acute dermal toxicity. An acute systemic inhalation DNEL was derived using the LOAEC value from the acute inhalation study as a starting point.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose, the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hrs exposure of general public). NAECcorr_inh = oral NOAEL (1000) x 1/1.15 m3/kg bw = 869.6 mg/m3. Oral absorption in rats in humans is assumed to be 100% and inhalation absorption in humans is assumed to be 100%. Therefore, NAECcorr_inh = 869.6 x 1 = 869.6 mg/m3
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- No allometric scaling required for inhalation route.
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22.2 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 1 663 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Not required
- Justification:
- Default factor when starting point is LOAEC, in accordance with REACH Guidance R.8
- Justification:
- No allometric scaling required for inhalation route.
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor for good quality database, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
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:
- 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assuming that oral absorption in rats is 100% and that dermal absorption in humans is 100%. Therefore dose descriptor after route to route extrapolation is 1000 x 100/100 = 1000 mg/kg bw/day.
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- Default factor (rat to human), in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Not required.
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- Default factor (rat to human), in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Default factor, in accordance with REACH Guidance R.8
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
The lowest NOAEL value was obtained in male rats in the 90 day oral repeated dose toxicity study, however, the nephrotoxicity observed in male rats is considered to be a species specific effect and not relevant to humans. The NOAEL for female rats in this study was established to be 100 mg/kg bw/day, however, no basis for this is provided therefore the NOAEL for female rats from the 28 day oral repeated dose toxicity study was selected as starting point for deriving the long-term systemic oral DNEL, the long-term systemic inhalation DNEL and the long-term systemic dermal DNEL. Acute and long-term inhalation local DNELs were not derived because it is considered that derivation from long term systemic effects provides a suitable margin for safety of use.
The substance is classified as a category 2 skin irritant, however, no dose response data are available therefore a qualitative risk assessment has been conducted. An acute systemic dermal DNEL and an acute systemic oral DNEL was not derived because the substance is not classified either for acute dermal toxicity or for acute oral toxicity. An acute systemic inhalation DNEL was derived using the LOAEC value from the acute inhalation study as a starting point.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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