Registration Dossier
Registration Dossier
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EC number: 204-653-4 | CAS number: 123-81-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-08-19 - 2003-12-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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)
- Remarks:
- Dept. of Health, UK
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium mercaptoacetate
- EC Number:
- 206-696-4
- EC Name:
- Sodium mercaptoacetate
- Cas Number:
- 367-51-1
- Molecular formula:
- C2H4O2S.Na
- IUPAC Name:
- sodium sulfanylacetate
- Reference substance name:
- NaTG
- IUPAC Name:
- NaTG
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Batch No. 5183
- Purity: 99.6 %
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 2.5%, 5%, 10% and 30% w/v in propylene glycol
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.17
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 2.32
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 6.7
- Test group / Remarks:
- 10%
- Remarks on result:
- other: Table of stimulation indices can be found in the executive summary below.
- Key result
- Parameter:
- EC3
- Value:
- 4.7
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- NaTG 98 %, pure is a skin sensitiser.
- Executive summary:
A sample of NaTG 98% was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The assay determines the level of T lymphocyte proliferation in the lymph nodes draining the site of chemical application, by measuring the amount of radiolabelled thymidine incorporated into the dividing cells. The test substance was initially applied as 0.25%, 0.5% or 1% w/v preparations in propylene glycol. A further group was subsequently dosed with a 2.5%, 5% or 10% w/v preparations in propylene glycol.
Concentration of test substance (% w/v)
Number of lymph nodes assayed
Disintegrations per minute (dpm)
dpm per lymph node
Test control ratio
0 (vehicle only)
8
1910
2.39
N/A
0.25
8
2213
2.77
1.16
0.5
8
3909
4.89
2.05
1.0
8
1756
2.2
0.92
0 (vehicle only)
8
4262
5.45
N/A
2.5
8
5102
6.38
1.17
5
8
10102
12.63
2.32
10
8
29199
36.5
6.7
The test substance was shown to have the capacity to cause skin sensitisation when applied as a 10% w/v preparation in propylene glycol.
In conclusion, NaTG 98% is a skin sensitiser.
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