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EC number: 245-642-4 | CAS number: 23410-40-4
- 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
GPMT (similar to OECD 406): sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was performed before LLNA method was first choice method
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory
- Age at study initiation:
- Weight at study initiation: approximately 350 g
- Housing: individually in stainless steel cages
- Diet: standard PURINA guinea pig chow, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: 7 days - Route:
- intradermal and epicutaneous
- Vehicle:
- other: DOW Corning 344 Fluid
- Concentration / amount:
- 5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: DOW Corning 344 Fluid
- Concentration / amount:
- 5%
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in DOW Corning 344 fluid
Injection 3: test substance in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in DOW Corning 344 fluid
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: DOW Corning 344 fluid
Injection 3: DOW Corning 344 fluid in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in DOW Corning 344 fluid
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: days 0-7
- Concentrations: intradermal 5%, epicutaneous 5%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: right flank (test substance) and left flank (vehicle)
- Concentrations: 5%
- Evaluation (hr after challenge): 24 h and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: CLP/EU GHS criteria are met, Category 1B classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a GPMT conducted to GLP and OECD 406 (reliability score 1) N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine was sensitising to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In the available key study (Dow Corning Corporation, 1985), the test item was investigated for skin sensitising properties in the Guinea Pig Maximization Test, conducted similar to the OECD TG 406, and in compliance with GLP. 20 Hartley guinea pigs per dose were induced with the test material by receiving 3 pairs of intradermal injections, followed by epicutaneous application of the test material 7 days later. Control animals received the vehicle only during the induction period. Challenge exposure was carried out by epicutaneous application of test item and the vehicle only to both test and control animals. The test material concentrations applied in this test were 5% for intradermal injections and epicutaneous induction, as well as for the challenge exposure. 24 and 48 h after chellenge exposure the animals were examined for skin reactions. None of the negative control animals showed any skin reaction at 24 and 48 h, respectively.In contrast, 9/20 animals (45%) induced with the test material showed skin reactions at both readings. Based on this data, the test material meets the criteria to be classified as a skin sensitiser (Cat 1B, H317) according to EC/1272/2008.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data is reliable and suitable for classification. Based on this data, the registered substance meets the criteria to be classified as a skin sensitiser (Cat 1B, H317) according to EC/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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