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Diss Factsheets
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EC number: 280-084-5 | CAS number: 82985-35-1
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. No information is given on the test material purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- use of 6 animals; observation period 7 d; rather occlusive conditions
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(trimethoxysilylpropyl)amine
- EC Number:
- 280-084-5
- EC Name:
- Bis(trimethoxysilylpropyl)amine
- Cas Number:
- 82985-35-1
- Molecular formula:
- C12H31NO6Si2
- IUPAC Name:
- 3,3,11,11-tetramethoxy-2,12-dioxa-7-aza-3,11-disilatridecane
- Details on test material:
- - Name of test material (as cited in study report): Organofunctional Silane Y-9492
- Physical state: clear, non-viscous liquid
- Lot/batch No.: 09989
- Identification: NB 2225-99
- BRRC Sample No.: 44-365
- Date of Receipt: 15 December 1981
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Fasting period before study: none
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
- Number of animals:
- 3 male and 3 female rabbbits
- Details on study design:
- TEST SITE
- Type of wrap if used: gauze patch loosely covered with impervious sheeting
REMOVAL OF TEST SUBSTANCE
- Washing: removal of test substance
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritant / corrosive response data:
- In addition to the oedema and erythema scores (see table 1) desquamation and fissuring was observed. Desquamation was observed in all animals from day 1 to day 7. Fissuring was observed after 5 h in all animals and was only present in the females after 24 h. In 1 animal fissuring was still observed after 7 d. The chemical residue was apparent on the skin in all animals at all time points.
Any other information on results incl. tables
Table 1: Individual results of the skin irritation study.
Observation time | Rabbit no. | |||||||||||
1 | 2 | 3 | 4 | 5 | 6 | |||||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | |
5 h | 2 | 1 | 4 | 1 | 4 | 1 | 2 | 1 | 2 | 1 | 1 | 1 |
24 h | 1 | 1 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 |
48 h | 2 | 1 | 2 | 2 | 2 | 2 | 1 | 0 | 1 | 2 | 1 | 2 |
72 h | 2 | 1 | 2 | 2 | 2 | 2 | 1 | 0 | 1 | 1 | 1 | 1 |
7 d | 2 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Mean value 24 + 48 + 72 h | 1.66 | 1 | 2 | 2 | 1.66 | 1.66 | 1 | 0.33 | 1 | 1.66 | 1 | 1.66 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was investigated for skin irritation/corrosion broadly according to the OECD TG 404, but not in compliance with GLP. 0.5 ml of the undiluted test material was occlusively applied to the clipped skin of 3 male and 3 female New Zeeland White rabbits. After 4 h of exposure the test material was removed and the animals were maintained for a 7 day-observation period. The mean erythema and oedema scores were 1.4 each and were not fully reversible until study termination. In addition, desquamation and fissuring was observed. Desquamation was observed in all animals from day 1 to day 7, whereas fissuring was observed after 5 h in all animals and was only present in the females after 24 h. In one animal fissuring was still observed after 7 d. The chemical residue was apparent on the skin in all animals at all time points. The authors concluded the test item to be slightly irritating. Nevertheless, since mean animal scores do not exceed 1.4, the individual scores at 24, 48, and 72 h reading time points never exceeded a score of 2, and individual animal scores throughout the only 7 days lasting observation period give evidence that the effects are transient, classification for skin irritation according to 67/584/EEC and EC/1272/2008 is not warranted.
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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