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Diss Factsheets
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EC number: 939-125-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 47 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 175 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)) = 1333 mg/kg bw/day*(1/0.38 m³/kg bw/day)*0.67*(0.5/1) = 1175 mg/m³. It is assumed that oral absorption rate is 50% 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:
- 2
- Justification:
- The DNEL is based on a subchronic 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:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.3 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 333 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It is assumed that the dermal absorption rate is 100% of that of the oral absorption as no adequate information is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The starting point has been derived in rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default value 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:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
There are no long term toxicity data available for “hydrolysis products of 3-(triethoxysilyl)propan-1-amine” (EC No. 939-125-9). In order to fulfil the standard information requirements set out in Annex VIII, read-across from a structurally related substance is conducted in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
The read-across is based on the hypothesis that the analogue substance, 3-(triethoxysilyl)propan-1-amine, hydrolyses rapidly in water resulting in the target substance. It can be expected that both the target and the source substance have similar behaviour under aqueous conditions. The target substance consists of 3-aminopropylsilanetriol and ethanol which are formed directly after hydrolysis and several condensation products such as dimers, trimers as well as polymers of siloxanes having similar functional groups (-O-Si- or HO-Si-). Therefore, it is considered that the target and the source substance are in one class of compounds and structural differences are not supposed to contribute to significant differences in activity with respect to eco- and human toxicological endpoints. A detailed analogue approach justification is provided in the technical dossier (Please refer to IUCLID Section 13 for further information).
The starting point for DNEL derivation is a no observed adverse effect level (NOAEL) of 200 mg/kg bw/day obtained from a repeated dose toxicity study according to OECD 408 (WIL Research Laboratories, 2001). The animals were treated at dose levels of 70, 200 and 600 mg/kg bw/day. At 600 mg/kg bw/day,pathological and histopathological findings were noted in the liver.Also an increase in the level of alanine aminotransferase and aspartate aminotransferase was observed in the high dose group. The animals showed labored respiration, gasping, partial closure of the eyes, general paleness, hypothermia, dermal atonia and/or tremors at 600 mg/kg bw/day. As the treatment-related effects were limited to the high dose group, the NOAEL was therefore 200 mg/kg bw/day. The study indicates that 3-(triethoxysilyl)propan-1-amine or its hydrolysis product is systemically bioavailable after repeated oral administration. Based on the fact that the hydrolysis product is formed in aqueous solutions of 3-(triethoxysilyl)propan-1-amine where the concentration range of 3-(triethoxysilyl)propan-1-amine is > 0.1 - < 16% (w/w), the available repeated dose toxicity study represents a worst case assumption. With respect to mixture rules, the NOAEL for hydrolysis products of 3-(triethoxysilyl)propan-1-amine (15%) is 1333 mg/kg bw/day (200 mg/kg bw/day x 100/15 = 1333 mg/kg bw/day).
According to the “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of [concentration]-response for human health, Version 2.1, November, 2012”, the oral NOAEL needs to be converted into a NOAEC:the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m3/kg for 8 h exposure). In addition, it should be taken into account that during 8 hours light activity at work the respiratory rate becomes higher (10 m3/person) than standard (6.7 m3/person). In the absence of route-specific information, a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route) in case of oral-to-inhalation extrapolation is included. The inclusion of factor 2 means that 50% (instead of 100%) absorption is assumed for oral absorption, and 100% for inhalation(Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of [concentration]-response for human health, Version 2.1, November 2012).Considering these differences, the corrected starting point is a NOAEC of 1175 mg/m³.
The long-term worker DNEL for dermal systemic effects is again based on the repeated dose toxicity study (WIL Research Laboratories, 2001) as there is no dermal repeated dose toxicity study. To convert the oral NOAEL [mg/kg bw/day] into a dermal NOAEL [mg/kg bw/day], the differences in absorption between routes as well as differences in dermal absorption between rats and humans have to be accounted for (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, December 2012). In the absence of any adequate information on dermal bioavailability, the bioavailability is expected to be in the same order of magnitude as oral absorption. This assumption results in the identical NOAEL for the oral and dermal exposure route.
In general, assessment factors (AF) recommended by ECHA (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health. European Chemicals Agency, Version 2.1, November, 2012) were used when applicable to derive the DNEL. The difference in metabolic rate between humans and the test species has been taken into account, where relevant. An AF for exposure duration is applied to take into account the difference between experimental exposure duration and the exposure duration for the worker.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The general population is not exposed to the substance based on its identified uses.
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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