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EC number: 237-511-5 | CAS number: 13822-56-5
- 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
- Study period:
- from 20 Jan 2003 to 3 Feb 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- This study was conducted largely according to the appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observations only to 7 days, when effects still evident
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(trimethoxysilyl)propylamine
- EC Number:
- 237-511-5
- EC Name:
- 3-(trimethoxysilyl)propylamine
- Cas Number:
- 13822-56-5
- Molecular formula:
- C6H17NO3Si
- IUPAC Name:
- 3-(trimethoxysilyl)propylamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA
- Age at study initiation: "young adult"
- Weight at study initiation: 3.018-3.171 kg
- Housing: 1/suspended wire mesh cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-19
- Humidity (%): 43.6-48.0. (The summary indicates the maximum humidity was 49.3%, the data provided do not appear to support this.)
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 2003-01-20 To: 2003-02-03 (14 days - although observational data are only given for 7 days)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat - Duration of treatment / exposure:
- 3 min
1 h
4 h - Observation period:
- 3-min: immediately and 1 (or 24) h
1-h: immediately and 24, 48, 73 h, and days 4 and 7
4-h: 1, 24, 48, 73 h, and days 4 and 7 - Number of animals:
- 1 rabbit: 3-min, 1 h, 4 h
2 further rabbits: 4 h - Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: not stated
- Type of wrap if used: 2-ply gauze secured with Micropore tape, overwrapped with gauze binder secured with Dermiform tape.
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 3 min, 1 h, 4 h
SCORING SYSTEM: Draize, 1965. Mean of 1, 24, 48, 72 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 1, 24, 48, 72 h mean
- Score:
- 1.8
- Max. score:
- 8
- Reversibility:
- other: effects evident at 7 days, no data given after 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days, no data given after 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days, no data given after 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 4-Hour exposure caused erythema and oedema (grade 1 or 2) in up to three animals; erythema persisted to the final observation at 7 days. See tables 1-3.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal after exposure for 3 minutes, at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
Immediately after exposure |
0 |
0 |
1 h* |
0 |
0 |
Reversibility* |
n/a |
n/a |
* the text describes a second observation at 1 h, the tabulated data describes the second observation at 24 h.
** Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Table 2: Irritant/corrosive response data for each animal after exposure for 1 hour, at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
Immediately after exposure |
0 |
0 |
24 h |
1 |
0 |
48 h |
1 |
0 |
72 h |
2a |
1 |
4 days |
1 |
1 |
7 days |
0b |
0 |
Reversibility* |
c |
n/a |
Average time (unit) for reversion |
7 days |
|
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
a erythema spreading outside dosed site to
b = desquamation
Table 3: Irritant/corrosive response data for each animal after exposure for 4 hour, at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
0/1/0 |
0/0/0 |
24 h |
1/2/1 |
0/2/1 |
48 h |
1/2/1 |
0/1/0 |
72 h |
2a/2/1 |
1/1/1 |
4 days |
2/1b/1 |
1/1/1 |
7 days |
0b/1b/1b |
0/0/0 |
Average 24 h, 48 h, 72 h (EU criteria) |
1.3/2/1 |
0.3/1.3/0.7 |
Average 1 h, 24 h, 48 h, 72 h (as given in report); PII=1.8 |
1.2 |
0.6 |
Reversibility* |
unclear |
c |
Average time (unit) for reversion |
No data at 14 days |
Day 7 |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
a erythema spreading outside dosed site to
b = desquamation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A reliable study conducted broadly in accordance with OECD 404 and GLP, found the test material to be slightly irritating to the skin of rabbits. According to EU criteria, classification as a skin irritant is required since the observed effects were not reversed at the end of the study.
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