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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
Endpoint summary
Administrative data
Description of key information
Oral (OECD 423): LD50 cut-off = 5000 mg/kg bw
Inhalation: no data available
Dermal (OECD 402): LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Jun - 17 Jul 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No information of analytical purity of the test material is provided.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: (HsdBrlHan:WIST)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: Step 1: 134 – 158 g (males), Step 2: 126 – 158 g (females), Step 3: 148 – 160 g (males), Step 4: 145 – 150 g (females)
- Fasting period before study: Animals were fasted by withholding food overnight and for a further 3 – 4 h after dosing.
- Housing: Animals were caged in macrolon cages on Altromin saw fiber bedding.
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: adequate period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 5 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no.: 21K0162
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
DOSAGE PREPARATION: The test substance was freshly mixed prior to application and stirred throughout dose administration to guarantee stability and homogeneity.
CLASS METHOD:
- Rationale for the selection of the starting dose: The starting dose was chosen according to OECD TG 423. - Doses:
- 200 mg/kg bw
Step 1: 3 males
Step 2: 3 females
2000 mg/kg bw
Step 3: 3 males
Step 4: 3 females - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: The animals were weighed prior to first application and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical examination was made twice a day on the day of dosing and once a day thereafter. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality observed throughout the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed throughout the observation period.
- Gross pathology:
- No special gross pathological changes were found in all animals.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In this acute toxic class method three fasted Wistar rats of each sex were administered one dose of 200 or 2000 mg/kg bw of the test substance (CAS 23432-65-7) in a stepwise procedure via oral gavage. The animals were observed for 14 days after administration. The acute oral LD50 cut-off value for males/females was calculated to be 5000 mg/kg bw. No signs of clinical toxicity and no mortalities occurred during the observation period. All animals showed the expected body weight gains over the study period. No treatment related gross necropsy findings were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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
- 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
- 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 - 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. - 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
Acute oral toxicity
A key acute oral toxicity study with methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) is available and was performed according to OECD TG 423 and in compliance with GLP (BSL, 2002). In this acute toxic class method three fasted Wistar rats of each sex were administered one dose of 200 or 2000 mg/kg bw of the test substance (CAS 23432-65-7) in a stepwise procedure via oral gavage. The animals were observed for 14 days after administration. The acute oral LD50 cut-off value for males/females was calculated to be 5000 mg/kg bw. No signs of clinical toxicity and no mortalities occurred during the observation period. All animals showed the expected body weight gains over the study period. No treatment related gross necropsy findings were observed. Based on the study results and according to EU classification criteria, the test substance is not to be classified.
Acute dermal toxicity
A key acute dermal toxicity study performed according to OECD TG 402 and in compliance with GLP with methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) is available (BSL, 2003). In this limit test five Wistar rats of each sex were exposed to 2000 mg/kg bw of the test substance for 24 h via occlusive dressing and observed for 14 days post-application. The acute dermal LD50 value for males/females was calculated to be greater than 2000 mg/kg bw. No signs of clinical toxicity were reported and no mortalities occurred during the observation period. No remarkable changes or differences in body weights were recorded. No treatment related gross necropsy findings were observed. Based on the study results and according to EU classification criteria, the test substance is not to be classified.
Justification for classification or non-classification
The available data on acute oral and dermal toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification. No data are available for the inhalation route.
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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