Registration Dossier
Registration Dossier
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EC number: 201-484-8 | CAS number: 83-53-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-dibromonaphthalene
- EC Number:
- 201-484-8
- EC Name:
- 1,4-dibromonaphthalene
- Cas Number:
- 83-53-4
- Molecular formula:
- C10H6Br2
- IUPAC Name:
- 1,4-dibromonaphthalene
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- The 0.50 cm² reconstructed epidermises (Episkin) were received on 27 February 2018. The same day, the insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The inserts were placed in 6 wells culture plate which had been previously filled with 300 μL of growth medium (Episkin) during 2 hours and 40 minutes. Then just before treatment, the inserts were placed in 24 wells culture plate which had been previously filled with 300 μL of maintenance medium (Episkin).
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 mg
- Duration of treatment / exposure:
- during 42 minutes
- Duration of post-treatment incubation (if applicable):
- 41 hours and 45 minutes post-incubation period
- Number of replicates:
- 3 living Reconstructed Human epidermis
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- ca. 114.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean percent viability of the tissues treated by the positive control was 1.4%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item 1,4-DIBROMONAPHTHALENE has to be considered as Non-irritant to skin, in accordance with the Regulation EC No. 1272/2008. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.
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