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EC number: 457-690-5 | CAS number: 23432-65-7
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Aug - 11 Sep 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate
- Cas Number:
- 23432-65-7
- Molecular formula:
- C6H15NO4Si
- IUPAC Name:
- methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 210 - 221 g (male), 198 - 208 g (female)
- Fasting period before study: no
- Housing: animals were barrier maintained (semi-barrier) in Macrolon Cages on Altromin saw fiber bedding
- Diet: Altromin 1324 maintenance diet for rats and mice (totally pathogen-free), ad libitum
- Water: tap water, ad libitum
- Acclimation period: adequate acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: not less than 10% of body surface
- Type of wrap if used: test item was held in contact with the skin with a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner
REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was removed by using water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination was made twice on the day of dosing and once daily thereafter, weighing was performed prior to application and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical examination included changes in the skin/fur, oedema and erythema, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality was observed during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed throughout the observation period.
- Gross pathology:
- Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were found in any animal.
- Other findings:
- No changes of the skin at the application site were observed.
Any other information on results incl. tables
Table 1: Weight gain [g] of the animals in the acute dermal toxicity study.
Animal No.
|
Sex |
Day 0 |
Day 7 |
Day 14 |
1 |
male |
218 |
249 |
293 |
2 |
male |
220 |
252 |
298 |
3 |
male |
210 |
243 |
286 |
4 |
male |
221 |
246 |
291 |
5 |
male |
213 |
232 |
260 |
6 |
female |
202 |
186 |
189 |
7 |
female |
208 |
217 |
229 |
8 |
female |
201 |
204 |
211 |
9 |
female |
205 |
209 |
233 |
10 |
female |
198 |
200 |
212 |
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:
- In an acute dermal toxicity study according to OECD guideline 402 and in compliance with GLP, no mortality and no clinical signs of toxicity were observed at the limit dose of 2000 mg/kg bw. Furthermore no skin reactions were observed after the 24-h treatment under occlusive conditions. In conclusion a LD50 >2000 mg/kg bw was derived.
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