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Toxicological information

Skin irritation / corrosion

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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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent

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