Registration Dossier
Registration Dossier
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EC number: 225-806-1 | CAS number: 5089-72-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.97 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:
- 1 048 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr = NOAELoral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 594.6 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(1/1)*0.67 = 1048 mg/m³. It is assumed that oral absorption rate is 100% of that of inhalation absorption. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans .
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
For N-[3-(triethoxysilyl)propyl]ethylenediamine several hazards were identified. In short term studies systemic effects (mortality) were observed in an acute inhalation toxicity study leading to Acute Tox Cat 4 classification. These effects were supposed to be secondary to local respiratory irritation, as the clinical signs of respiratory irritation precede mortality and pathology revealed effects on the lung. The respiratory effects were concentration dependent.
In addition local effects as skin irritation, eye corrosion and skin sensitisation (Cat 1B) were observed or presumed based on structure and data from structural analogues.
No hazard leading to classification was observed for long-term systemic toxicity. For safety assessment of long-term systemic toxicity an available screening study according to OECD TG 422 and the corresponding range-finding test was used. A NOAEL of 500 mg/kg bw/day (highest dose tested) was derived in the main study. The doses were chosen based on the range-finding test, were mortality was observed (1/3 males, 1/3 females) between day 4-6 at 1000 mg/kg bw/day.
The DNEL for systemic effects after repeated inhalation exposure was calculated based on the NOAEL of 500 mg/kg bw/day of the screening study. Standard ECHA REACH Guidance assessment factors were applied after route-to-route extrapolation. Before calculation of the dose descriptor starting point the NOAEL was corrected for differences in molecular weight. A DNEL of 13.97 mg/m³ was calculated.
Based on the local effects observed such as skin irritation, eye corrosion and skin sensitisation (Cat 1B) no DNEL was calculated for the dermal route, neither for local nor for systemic effects. To ensure safe handling a qualitative assessment was carried out with respect to the local properties; assigning the substance into the moderate hazard class according to ECHA CSA Guidance Part E Table E 3-1 (see CSR section 9/10).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
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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