Registration Dossier
Registration Dossier
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EC number: 627-063-2 | CAS number: 1134960-41-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU/OECD-guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate
- EC Number:
- 627-063-2
- Cas Number:
- 1134960-41-0
- Molecular formula:
- C6H5O5Na
- IUPAC Name:
- sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% aqueous Pluronic PE9200
- Concentration:
- 50, 25 and 10% (w/v) in 1% Pluronic
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
Any other information on results incl. tables
| Test Group Name |
Animal Number | Measured Total DPM | DPM | Number of lymph nodes |
| Negative control (1% Pluronic) | 1 2 3 4 5 |
187 60 104 51 191 |
149.5 22.5 66.5 13.5 153.5 |
2 2 2 2 2 |
| 50% (w/v) in 1% Pluronic | 6 7 8 9 10 |
119 278 61 149 168 |
81.5 240.5 23.5 111.5 130.5 |
2 2 2 2 2 |
25% (w/v) in 1% Pluronic |
11 12 13 14 15 |
88 136 213 203 90 |
50.5 98.5 175.5 165.5 52.5 |
2 2 2 2 2 |
10% (w/v) in 1% Pluronic |
16 17 18 19 20 |
99 98 90 498 149 |
61.5 60.5 52.5 460.5 111.5 |
2 2 2 2 2 |
Positive control (25% HCA in 1% Pluronic) |
21 22 23 24 25 |
4331 955 945 645 866 |
4293.5 917.5 907.5 607.5 828.5 |
2 2 2 2 2 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under the conditions of the present assay the test substance was shown to have no sensitization potential (non-sensitizer) in the Local Lymph Node Assay.
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