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EC number: 268-071-2 | CAS number: 68002-58-4 This substance is identified by SDA Substance Name: C14-C18 dialkyl dimethyl ammonium methyl sulfate and SDA Reporting Number: 17-049-00.
- 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
Acute oral toxicity: LD50 > 10000 mg/kg bw, performed before implementation of GLP and OECD guidelines; RL2
Acute inhalation toxicity: exposure consideration + no acute intrinsic toxicity expected; no testing required
Acute dermal toxicity: LD50 expected to be > 2000 mg/kg bw; no testing required
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:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- - Principle of test: Six male Sprague-Dawley rats were administered either 5 or 10 g/kg bw of a 25 % solution (in distilled water) of the test substance by oral gavage.The animals were observed for two weeks.
- Short description of test conditions: Animals were given a single dose and then placed in screen bottom cages with free access to water and laboratory chow for a two week observation period.
- Parameters analysed / observed: Mortality - GLP compliance:
- no
- Remarks:
- performed before implementation of GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150-250 g
- Fasting period before study: 24 h
- Housing: screen bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
MAXIMUM DOSE VOLUME APPLIED: not specified
DOSAGE PREPARATION (if unusual): none
- Doses:
- 5 and 10 g/kg bw
- No. of animals per sex per dose:
- 6 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not examined
- Necropsy of survivors performed: no - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- One animal died on day 7 in the 10 g/kg bw group
- Clinical signs:
- other: not reported
- Gross pathology:
- not examined
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The single administration of 10 mg/kg bw C14-18 alykldimethyl ammonium methosulfate to male Sprague-Dawley rats caused one death among 6 animals in this dosage group on observation day 7. The other animals, i.e. 6 animals in the 5 g/kg bw dosage group and 5 animals in the 10 g/kg bw dosage group survived during the whole experimental time Thus, the LD50 of the test substance was considered to be > 10 g/kg bw.
- Executive summary:
In an acute oral toxicity study (performed before implementation of GLP and OECD guidelines), groups of 6 male fasted Sprague-Dawley rats were given a single oral dose of C14 -18 alkyldimethyl ammonium methosulfate (89% a.i.) in water at doses of 5 or 10 g/kg bw and observed for 14 days. One animal died on day 7 in the 10 g/kg bw group; all animals of the 5 g/kg bw group survived to the end of the observation period.
Oral LD50 Males >10 g/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
In an acute oral toxicity study (performed before implementation of GLP and OECD guidelines), groups of 6 male fasted Sprague-Dawley rats were given a single oral dose of C14 -18 alkyldimethyl ammonium methosulfate (89% a.i.) in water at doses of 5 or 10 g/kg bw and observed for 14 days. One animal died on day 7 in the 10 g/kg bw group; all animals of the 5 g/kg bw group survived to the end of the observation period.
Similarly low acute toxicity was observed for the source substances DODMAC and DHTDMAC:
LD50 values of 11,300 mg/kg bw (2260 mg a.i./kg bw) for males and of 13,000 (2600 mg a.i./kg bw) mg/kg bw for females were detected for DODMAC. The LD0 of the 75% dilution of DHTDMAC is >/=5000 mg/kg bw (3750 mg a.i./kg bw).
In contrast to that, the source substance DDAC exhibited marked acute toxicity. The LD50(combined) of DDAC is reported to be 238 mg/kg bw in rat.
These data are used to justify the read-across for repeated dose toxicity.
Acute inhalation toxicity
Given that inhalation is not a relevant route of exposure, testing by the inhalation route is not necessary according to REACH Regulation Annex VIII 8.5.2 Column 2. Inhalation is not a relevant route of exposure to Di-C14-18 alkyldimethyl ammonium methosulfate. This applies to both workers and the general population and is due to the physicochemical properties of the substance and the nature of the products where it is used. Di-C14-18 alkyldimethyl ammonium methosulfate is a waxy solid. Generation of inhalable particles such as dust or aerosols is therefore not to be expected. Vaporisation needs not to be considered due to the substance’s very low vapour pressure of </=1.13E-013 Pa at 25°C. Results of laboratory animal studies show a low acute toxicity after oral exposure. Therefore the acute intrinsic toxic activity of Di-C14-18 alkyldimethyl ammonium methosulfate is considered to be low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.
Acute dermal toxicity
The testing of acute dermal toxicity of C14 -18 alkyldimethyl ammonium methosulfate is scientifically not justified. According to the COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity, recent “scientific analysis of available data from in vivo acute toxicity studies have shown that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. Therefore, testing those substances via the dermal route does not provide essential information for their safety assessment.” The oral LD50 of C14 -18 alkyldimethyl ammonium methosulfate was determined to be > 10000 mg/kg bw. Thus, no toxicity via the dermal route is to be expected.
Based on the available information, the acute toxicity C14 -18 alkyldimethyl ammonium methosulfate is low. There are no data gaps in acute toxicity. Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.
Justification for classification or non-classification
Based on the available relevant and reliable data C14 -18 alkyldimethyl ammonium methosulfate does not need to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to acute toxicity.
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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