Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: - | CAS number: -
- 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
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- From 1972 to 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test performed before OECD and GLP guidelines. Important aspects (14 day-postobservation time) in line with current OECD guidelines.
- Justification for type of information:
- Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Acute oral toxicity after single application
- GLP compliance:
- no
- Remarks:
- Performed before GLP guidelines
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst
- Age at study initiation: no data
- Weight at study initiation: 82-104 g (mean 93 g )
- Fasting period before study: 16 h
- Housing: in plastic cages
- Diet (e.g. ad libitum): Standard Altromin R, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 %
- Amount of vehicle (if gavage): dependent on dose, not constant
- Justification for choice of vehicle: not given
MAXIMUM DOSE VOLUME APPLIED: 50 mL/kg - Doses:
- 800, 1250, 2000, 3200, and 5000 mg/kg
- No. of animals per sex per dose:
- 10 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing once per week
- Necropsy of survivors performed: unclear from report
- Other examinations performed: body weight, no further information - Statistics:
- LD50 was calculated using Probit analysis
- Preliminary study:
- No sex differences were observed in preliminary study, therefore only females were used in the main study
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 190 mg/kg bw
- Remarks on result:
- other: not classified
- Mortality:
- The following number of deaths were observed per dose group:
dose (mg/kg) -- number of death animals -- number of total animals
800 -- 0 -- 10
1250 -- 0 -- 10
2000 -- 1 -- 10
3200 -- 5 -- 10
5000 -- 10 -- 10 - Clinical signs:
- other: Not reported
- Gross pathology:
- Uunclear if done
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- (not classified)
- Conclusions:
- Based on the results of the read across study, the acute oral LD50 of the substance in rats is considered to be 3190 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the read across substance, C20-22 TMAC (active: 96.6%), according to a method similar to OECD Guideline 401 (standard acute method). Group of 10 female wistar rats each were administered read across substance at doses of 800, 1250, 2000, 3200 and 5000 mg/kg bw by oral gavage. Following administration, the animals were observed for 14 d and mortality and body weights were recorded daily. Dose dependant mortality was observed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be 3190 mg/kg bw (Scholz and Weigand, 1973). Based on the results of the read across study, similar oral LD50 is expected for the test substance, C18-22 TMAC.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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