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EC number: 854-560-3 | CAS number: 1891094-25-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- START OF EXPERIMENT : 04 January 2017 END OF EXPERIMENT : 10 January 2017 AMENDMENT 2 TO THE STUDY PLAN : 10 March 2017. Final report 14 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate
- EC Number:
- 854-560-3
- Cas Number:
- 1891094-25-9
- Molecular formula:
- C53H38N4Na6O22S5
- IUPAC Name:
- hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- AKR
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: pluronic
- No. of animals per dose:
- 5
- Details on study design:
- In the main assay, twenty five female CBA/CaOlaHsd mice were allocated to five groups of
five animals each:
three groups received the appropriate formulation of Dye-2016 at concentrations of 25, 10 and 5% (w/v) in 1% Pluronic,
- the negative control group received 1% Pluronic,
- the positive control group received 25% (w/v) α-Hexylcinnamaldehyde (HCA) in
1% Pluronic. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde (25% (w/v) dissolved in 1% Pluronic) was used as a positive control to demonstrate the appropriate performance of the assay [1]. A significant lymphoproliferative response (stimulation index value of 11.3) was noted for the positive control chemical and this result confirmed the validity of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- negative control group
- Parameter:
- other: DPN
- Value:
- ca. 213.8
- Test group / Remarks:
- negative control group
- Parameter:
- SI
- Value:
- 1.3
- Variability:
- 25% (w/v)in 1% pluronic
- Test group / Remarks:
- dye in pluronic
- Parameter:
- SI
- Value:
- 1.2
- Variability:
- 10% (w/v)in 1% pluronic
- Test group / Remarks:
- dye in pluronic
- Parameter:
- SI
- Value:
- 1.1
- Variability:
- 5% (w/v)in 1% pluronic
- Test group / Remarks:
- dye in pluronic
Any other information on results incl. tables
No mortality or systemic toxicity was observed during the study. In all test item treated
groups, test item precipitate or minimal test item precipitate was present on the ears of the
animals from Day 1 up to the end of treatment
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present assay, the test item , tested in a suitable vehicle, was shown to have no sensitisation potential (nonsensitizer) in the Local Lymph Node Assay. The test substnace is not sensitiser.
- Executive summary:
Introduction
The aim of this study was to determine the skin sensitization potential of Dye-2016 following
dermal exposure. The study was performed with vertebrate animals as no regulatory in vitro
alternative for full classification is available. The minimum number of animals was used,
corresponding to the regulatory guidelines being followed.
Results and Conclusion
Under the conditions of the present assay, the test item , tested in a suitable vehicle, was shown to have no sensitisation potential (nonsensitizer) in the Local Lymph Node Assay.
The following classification/labelling is triggered: Regulation (EC) No 1272/2008 (CLP) / GHS (rev. 6) 2015: None.
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