Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 916-226-6 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 431
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Principles of method if other than guideline:
- The experiment was carried out on a reconstructed human epidermis EST-1000 (CeIiSystems, St. Katharinen, Germany)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzyldodecylbis(2-hydroxypropyl)ammonium chloride
- EC Number:
- 265-345-3
- EC Name:
- Benzyldodecylbis(2-hydroxypropyl)ammonium chloride
- Cas Number:
- 65059-91-8
- Molecular formula:
- C25H46NO2.Cl
- IUPAC Name:
- N-benzyl-N,N-bis(2-hydroxypropyl)dodecan-1-aminium chloride
- Details on test material:
- Content of components of Katalysator WAZ 5596-8:
content of quaternary propoxylated fatty amine 54.6%
content of propoxylated fatty amine 1.3%
content of hvdrochloride propoxylated fatty amine 14.6 %
propane-1,2-diol 5.1%
a-chlorotoluene 12.9 %
sulfated ash <0.05%
water content 8.3 %
content of chloride 6.0%
Constituent 1
Test animals
- Species:
- other: not applicable - in-vitro 3D skin corrosion test
- Strain:
- other: not applicable - in-vitro 3D skin corrosion test
Test system
- Type of coverage:
- other: not applicable - in-vitro 3D skin corrosion test
- Preparation of test site:
- other: not applicable - in-vitro 3D skin corrosion test
- Vehicle:
- other: not applicable - in-vitro 3D skin corrosion test
- Controls:
- other: not applicable - in-vitro 3D skin corrosion test
- Duration of treatment / exposure:
- After an exposure period of 3 or 60 minutes, followed by a post-treatment incubation period of about 3 hours, the cell viability was measured
- Observation period:
- not applicable - in-vitro 3D skin corrosion test
- Number of animals:
- not applicable - in-vitro 3D skin corrosion test
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability
- Value:
- 104.76
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 minutes. Max. score: 100.0. Reversibility: other: not applicable - in-vitro 3D skin corrosion test. Remarks: non corrosive - scores in [%] viability. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability
- Value:
- 52.07
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 minutes. Max. score: 100.0. Reversibility: other: not applicable - in-vitro 3D skin corrosion test. Remarks: non corrosive - scores in [%] viability. (migrated information)
Any other information on results incl. tables
Compound [%] Cell viability 3 min [%] Cell viability 60 min Classification*
Katalysator WAZ 5596 -B 104.76 52.07 Non-corrosive
Negative control 100 100 Negative control
*: Classification was done in accordance with the existing guideline and
internationally accepted protocols, Le. evaluation of LD50 values after 3 min. and/or less than 15% viability after a 60 min. incubation period.
Substances are classified as "corrosive (R34)", if the cell viability of the EST 1000 is decreased by more than 50% after 3 min. of incubation to the test item, or if the cell viability is less than 15% after 60 min. of exposure to the test item.
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosive
- Executive summary:
The experiment was carried out according to OECD 431 and EU Test Method B.40 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany).
Undiluted Katalysator WAZ 5596 -B was applied topically to the RHS model, i.e. 50 µl per insert
After an exposure period of 3 or 60 minutes, followed by a post-treatment incubation period of ca. 3 hours, the cell viability was measured to be 104.76 or 52.07 % respectivley, in the MTT (Methylthiazoletetrazolium) conversion assay.
The results of the concurrent negative control (NC, 0.9% NaCl) and positive controls demonstrated the viability (NC) and sensitivity (PC) of the test model.
Thus, the results show that Katalysator WAZ 5596 -B should not be labelled as corrosive to skin
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.