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EC number: 824-801-7 | CAS number: 1093628-27-3
- 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:
- Study Start 7th September 2006 - Study Report 16th February 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-amino-N,N-dimethylpropan-1-aminium 2-C10-13-alkyl benzenesulfonate
- EC Number:
- 824-801-7
- Cas Number:
- 1093628-27-3
- Molecular formula:
- not applicable
- IUPAC Name:
- 3-amino-N,N-dimethylpropan-1-aminium 2-C10-13-alkyl benzenesulfonate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Identity Witconate P-1460
Description Light brown paste
Batch number 2140-5901
Activity 88.8 %
Stability of test item Stable under storage conditions.
Expiry date V 07-APR-2007
Stability of test item dilution Unknown in water; excluded from the statement of
compliance.
Storage conditions At room temperature (range of 20 1: 5 °C), light protected.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanRcc:WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Number of animals per group: 5 males and 5 females
Total number of animals: 5 males and 5 females
Age when treated: Males: 8 weeks, Females: 11 weeks
Identification: By unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study
HUSBANDRY
Conditions: air changes per hour, and continuously monitored environment with ranges for room temperature 22 +/- 3 °C and for relative humidity between 30-70 % (values above 70 %during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding
("Lignocel", SchillAG, CH-4132 Muttenz) during treatment and observation.
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 36/06 (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd.
Water: Community tap water from FülIinsdorf ad Iibitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- Purified water prepared at RCC Ltd (deionised water which was processed and treated by the PURELAB Option-R unit. This latter links four purification technologies: reverse osmosis, adsorption, ion-exchange and photo oxidation).
- Details on dermal exposure:
- Dose Formulation
The dose levels are in terms of the test item as supplied by the sponsor. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The formulation was prepared shortly before the application using a magnetic stirrer, a spatula and an Ultra-Turrax (Janke & Kunkel, D-79219 Staufen) as homogenizers. Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
TREATMENT
One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface.
Only those animals without injury or irritation on the skin were used in the test.
On test day 1, the test item was applied at a dose of 2000 mglkg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Application volume/kg body weight: 6 mL
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.
The fur of all animals was shaved on test days 5 and 12 just after the assessment of the reaction to facilitate the skin reading for the next day.
Rationale: Dermal administration was used as this is one possible route of human exposure during manufacture, handling and use of the test item. - Duration of exposure:
- 14 days with termination on day 15.
- Doses:
- On test day 1, the test item was applied at a limit dose of 2000 mg/kg body weight evenly on the intact skin.
- No. of animals per sex per dose:
- Single limit dose group of 5 males and 5 females.
- Control animals:
- not required
- Details on study design:
- On test day 1, the test item was applied at a dose of 2000 mglkg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Application volume/kg body weight: 6 mL
Mortality/Viability: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice
daily during days 2-15.
Bodyweights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2—15. All abnormalities were recorded.
Local signs: Once daily during days 2-15. All abnormalities were recorded.
NECROPSY
All animals were killed at the end of the observation period by Carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained. - Statistics:
- No statistical analysis was used as this was a sinlge dose level, limit dose study.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No systemic signs of toxicity were observed during the study period. The test item induced local changes at the application site. A moderate erythema was noted in all animals on test day 2 after removal of the dressing and persisted as moderate or slight
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of Witconate P-1460 after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat):greater than 2000 mglkg body weight.
There were no indications of systemic toxic effects in any of the rats at the 2000 mg/kg limit dose. Therefore the test substance is not classified under EU CLP as the dermal LD50 is greater than category 4 (>2000mg/kg bodyweight). Based on the lack of any systemic toxicity at this dose, it is concluded that there is unlikely to be an LD50 less than 5000mg/kg so GHS criteria even for category 5 for acute dermal toxicity would not apply in regions where this has been adopted outside the EU. - Executive summary:
RESULTS
Five male and five female Hacc:W|ST (SPF) rats were treated with Witconate P-1460 at 2000 mg/kg by dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.33 glmL and administered at a volume dosage of 6 mL/kg. The application period was 24 hours.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day1 (prior to administration) and on days8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study.
No clinical signs of toxicity were observed during the course of the study.
Local signs of irritation were noted at the application site of the animals. These includederythema, scabs, scaling, oedema, fissures and brown patchy discoloration. The local findings were reversible in four males and four females whereas one male and one male still expressed local symptoms at the end of the observation period.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were observed at necropsy.
CONCLUSION
The median lethal dose of Witconate P-1460 after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat):greater than 2000 mglkg body weight
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