Registration Dossier
Registration Dossier
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EC number: 916-226-6 | CAS number: -
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
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