Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-337-1 | CAS number: 3069-33-8
- 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, Germany
Test material
- Reference substance name:
- N-[3-(methoxydimethylsilyl)propyl]ethylenediamine
- EC Number:
- 221-337-1
- EC Name:
- N-[3-(methoxydimethylsilyl)propyl]ethylenediamine
- Cas Number:
- 3069-33-8
- Molecular formula:
- C8H22N2OSi
- IUPAC Name:
- (2-aminoethyl)[3-(methoxydimethylsilyl)propyl]amine
- Details on test material:
- - Name of test material (as cited in study report): VP 50991
- Physical state: colourless liquid
- Storage condition of test material: at room temperature, dry, tightly closed, dark
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: 1.6 - 2 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
- 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:
- mean
- Remarks:
- out all all three animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all three animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Erythema grade 3 were observed in all 3 animals from 60 min to 14 days after exposure. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch. Oedema reactions were fully reversible within 24 h in all 3 animals. A pale yellow or light-red bordered application site was observed in all animals 24 h after exposure until the end of the 14 day observation period. Necrosis at the application site was observed after 72 h (2/3 animals) or 4 days (1/3 animals) after patch removal. Peeling of the application site was observed in 2/3 animals after 14 days.
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 |
3 |
1 |
3 |
1 |
3 |
1 |
24 h |
3 a,b |
0 |
3 a,b |
0 |
3 a,b |
0 |
48 h |
3 a,b |
0 |
3 a,b |
0 |
3 a,b |
0 |
72 h |
3 a,b,c |
0 |
3 a,b,c |
0 |
3 a,b |
0 |
14 d |
3 a,b,c |
0 |
3 a,b,c,d |
0 |
3 a,b,c,d |
0 |
Mean value |
3 |
0 |
3 |
0 |
3 |
0 |
24 + 48 + 72 h |
a: skin induration
b: application site (pale) yellow or light-red bordered
c: necrosis of the whole application site
d: peeling of the application site
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A reliable study performed in accordance with OECD 404 and GLP found the test material to be corrosive to the skin of rabbits. Erythema mean scores of 3 were observed and were not reversible within the observation period. Oedema mean scores were 0 for all animals. Necrosis at the application site was observed 3 days after patch removal in all animals respectively.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.