Registration Dossier
Registration Dossier
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EC number: 204-171-4 | CAS number: 117-08-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 431
- 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:
- Tetrachlorophthalic anhydride
- EC Number:
- 204-171-4
- EC Name:
- Tetrachlorophthalic anhydride
- Cas Number:
- 117-08-8
- Molecular formula:
- C8Cl4O3
- IUPAC Name:
- tetrachloro-1,3-dihydro-2-benzofuran-1,3-dione
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 vivo
Resultsopen allclose all
- Irritation parameter:
- other: cell viability
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 98.54
- Max. score:
- 100
- Reversibility:
- other: not applicable - in-vitro 3D skin corrosion test
- Remarks on result:
- other: non irritant - scores in [%] viability
- Irritation parameter:
- other: cell viability
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- 87.85
- Max. score:
- 100
- Reversibility:
- other: not applicable - in-vitro 3D skin corrosion test
- Remarks on result:
- other: non corrosive - scores in [%] viability
Any other information on results incl. tables
Compound [%] Cell viability 3 min [%] Cell viability 60 min Classification*
Tetrachlorophthalic anhydride 98.54 87.85 Non-corrosive
Negative control 100 100 Non corrosive
Positive control (SDS 5%) - - -
Positive control (1H-1,2,4 -Triazole-3thiol - - -
*: Classification was done in accordance with EU Test Method B.46.
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 tetrachlorophthalic anhydride 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 98.54 or 87.85 % 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 tetrachlorophthalic anhydride should not be labelled as corrosive to skin
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