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EC number: 225-806-1 | CAS number: 5089-72-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Hamburg, Germany
Test material
- Reference substance name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
- EC Number:
- 225-806-1
- EC Name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
- Cas Number:
- 5089-72-5
- Molecular formula:
- C11H28N2O3Si
- IUPAC Name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 4 months
- Weight at study initiation: 1.9 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. During exposure the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn.
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55± 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 June 2002 To: 22 Aug 2002
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days; reading time points: 1, 24, 48, and 72 h after patch removal
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: Test site covered with a gauze patch, which was held in contact to the skin by means of a semi-occlusive dressing (non-irritating tape).
REMOVAL OF TEST SUBSTANCE
No residual test substance had to be removed.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Erythema grade 1 (2/3 animals) and 2 (1/3 animals) were observed 60 min after patch removal. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch but were fully reversible within 24 h (2/3) and 72 h (1/3), respectively. Skin induration was observed in all 3 animals from day 4 until the end of the study. A dark brown discoloured application area was observed in one animal from 4 days to the end of the study. Peeling of the application site was observed in 3/3 animals after 9 days and persisted until the end of the study. Laceration of skin induration was observed in 1/3 animals at day 6, 7, and 9.
Any other information on results incl. tables
Table 1: Individual results of the skin irritation test.
Rabbit No. |
1 |
2 |
3 |
|||
Observation time |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 h |
2 |
1 |
1 |
1 |
1 |
1 |
24 h |
2 |
1 |
1 |
0 |
1 |
0 |
48 h |
2 |
1 |
1 |
0 |
1 |
0 |
72 h |
2 |
0 |
1 |
0 |
1 |
0 |
14 d |
2 a,b,c |
0 |
1 a,c |
0 |
1 a,c |
0 |
Mean value |
2 |
0.66 |
1 |
0 |
1 |
0 |
24 + 48 + 72 h |
a: skin induration
b: application site dark brown discoloured
c: peeling of the application site
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- A reliable study performed in accordance with OECD 404 and GLP found the test material to be irritating to the skin of rabbits. Erythema grade 1 (2/3 animals) and 2 (1/3 animals) were observed 60 min after patch removal. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch but were fully reversible within 24 h (2/3) and 72 h (1/3), respectively. Skin induration was observed in all 3 animals from day 4 until the end of the study. A dark brown discoloured application area was observed in one animal from 4 days to the end of the study. Peeling of the application site was observed in 3/3 animals after 9 days and persisted until the end of the study. Laceration of skin induration was observed in 1/3 animals at day 6, 7, and 9. No systemic effects were reported.
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