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EC number: 252-390-9 | CAS number: 35141-30-1
- 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
Endpoint summary
Administrative data
Description of key information
OECD 406 (GPMT): sensitising (intradermal induction with 0.1% test
substance preparation) (RA from
N-(3-(trimethoxysilyl)propyl)ethylenediamine, CAS 1760-24-3)
OECD 406 (GPMT): sensitising (intradermal induction with 0.5% test
substance preparation) (RA from
N-(3-(trimethoxysilyl)propyl)ethylenediamine, CAS 1760-24-3)
OECD 429 (LLNA): sensitising (RA from
N-(3-(trimethoxysilyl)propyl)ethylenediamine, CAS 1760-24-3)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction 0.1% (v/v); challenge 10% (v/v)
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: CAS 1760-24-3, Hazleton France, 1992
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction 0%; challenge 10% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: CAS 1760-24-3, Hazleton France, 1992
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction 0.1% (v/v); challenge 10% (v/v)
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: CAS 1760-24-3, Hazleton France, 1992
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction 0%; challenge 10% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: CAS 1760-24-3, Hazleton France, 1992
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: CLP/EU GHS Category 1A (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- In two guinea pig maximisation study conducted to OECD 406 and to GLP the source substance N-(3-(trimethoxysilyl)propyl)ethylenediamine provoked a positive reaction in 30% and 100% of the test animals. Hence, the source substance is considered to be a skin sensitiser. This result is also supported by an LLNA test. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in skin sensitisation potential.
Reference
Two further in vivo skin sensitisation studies are available for the source substance CAS 1760 -24 -3:
SafePharm Laboratories Ltd., 1987: GPMT
intradermal indution: 0.5%, topical induction: 100%, topical challenge: 100%
1st reading at 24 hours: test group: 20/20 positive reactions
1st reading at 48 hours: test group: 19/20 positive reactions
1st and 2nd reading at 24 and 48 hours, respectively: control group: 0/20 positive reactions
BSL Bioservice, 2005: LLNA
tested concentrations: 5, 10, 25 and 50%
EC3 = 13%
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No data are available to assess the skin sensitisation potential of N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine (CAS 35141-30-1). Therefore, the risk assessment was performed based on the available data from the source substance N-(3-trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from an analogue substance has been applied to support the human health hazard assessment of N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]-ethylenediamine (CAS 35141-30-1). Further details are provided in the analogue justification attached to the respective target entry.
There are three good quality skin sensitisation studies with the source substance, all of which give clear positive results.
The key study is a guinea pig maximisation test, conducted according to OECD 406 and in compliance with GLP. Animals were intradermally induced with 0.1% test substance solution and epicutaneously induced with 10% test substance solution. Challenge exposure was conducted with 10% test substance formulation and provoked a positive reaction in 30% of the test animals, concluding the test substance to be a strong skin sensitiser (Cat 1A according to Regulation (EC) No 1272/2008) (Hazleton France, 1992).
Two supporting studies are in accordance with the findings of the key study. The first study, also a guinea pig maximisation test, was conducted according to OECD 406 and in compliance with GLP. Animals were intradermally induced with 0.5% test substance solution and epicutaneously induced with undiluted test substance. Challenge exposure was conducted with neat test substance and provoked a positive reaction in 100% of the test animals, concluding the test substance to be a strong skin sensitiser (Cat 1A according to Regulation (EC) No 1272/2008) under the conditions of this test (SafePharm Laboratories Ltd, 1987).
A second supporting study employed a mouse Local Lymph Node Assay, conducted according to OECD 429 and in compliance with GLP. The stimulation indices for 5, 10, 25 and 50% test substance (in 3+1 (v/v) acetone/olive oil) were 1.7, 2.5, 4.7 and 7.9, respectively. The negative and positive (P-Phenylenediamine) controls gave stimulation indices of 1.0 and 12.1, respectively. Based on these results, the EC3 value was calculated at a concentration of 13% of the test substance. The test substance was therefore a sensitiser (Cat 1B according to Regulation (EC) No 1272/2008) under the conditions of this test (BSL BIOSERVICE Scientific Laboratories GmbH, 2005).
The most recent guinea pig maximisation test was selected as key study since the mouse Local Lymph Node Assay has not been generally accepted as suitable for alkoxysilanes due to the likelihood of false positive results (Basketteret al., 2009). However, in this case it was in concordance with the clear evidence for sensitising potential of the registered substance.
Basketter D, Ball N, Cagen S, Carillo JC, Certa H, Eigler D, Garcia C, Esch H, Graham C, Haux C, Kreiling R, Mehling A (2009a). Application of weight of evidence approach to assessing discordant sensitisation datasets: implication for REACH. Reg. Toxicol. Pharmacol.,55, 90-96.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on reliable data from the analogue substance N-(3 -(trimethoxysilyl)propyl)ethylenediamine (CAS 1760 -24 -3), the registered substance N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine(CAS 35141-30-1) is classified as 'Skin Sens. 1A with the hazard statement 'H317: May cause an allergic skin reaction' according to Regulation (EC) No 1272/2008.
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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