Registration Dossier
Registration Dossier
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EC number: 207-529-8 | CAS number: 479-27-6
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:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- 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:
- 1,8-naphthylenediamine
- EC Number:
- 207-529-8
- EC Name:
- 1,8-naphthylenediamine
- Cas Number:
- 479-27-6
- Molecular formula:
- C10H10N2
- IUPAC Name:
- naphthalene-1,8-diamine
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:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 107.29
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 50.65
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
Any other information on results incl. tables
Compound [%] Cell viability 3 min [%] Cell viability 60 min Classification*
1,8-naphthylenediamine 107.29 50.05 Non-corrosive
Negative control 100 100 Negative control
*: Classification was done in accordance with the existing guideline and internationally accepted protocols, i.e. evaluation of LD50 values after 3 min. and/or less than 15% viability after a 60 min. incubation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosive
- Executive summary:
The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives with the test item 1,8-naphthylenediamine (Deltamin).
Corrosive skin effects of substances are defined as irreversible damage of skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to four hours. In vivo corrosive reactions are typified by ulcers, bleeding, and bloody scabs.
A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively. By this the study, was conducted in accordance with the OECD 431 guideline as well as with an EC guideline (amending Council Directive 67/548/EEC, B.40 Skin corrosion) using the test item concentrations and incubation periods recommended there. These tests are also related to the revised OECD 404 guideline "Acute Dermal Irritation/Corrosion".
To check the reliability of this test procedure a blinded positive/negative control study is conducted at regular intervals in the lab. This reliability check is always performed by two technicians, two laboratories in parallel using the same batches of the control test items.
The test item was applied at a 100% concentration, i.e. 50 µg per insert.
The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 107% and 50% (rounded), respectively. Thus, the results show that no corrosive property of the test item was determined by the assay used.
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