Registration Dossier
Registration Dossier
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EC number: 202-495-0 | CAS number: 96-27-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- yes
- Remarks:
- TS not characterised
- Principles of method if other than guideline:
- LLNA with pre-guidleine methodology
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-mercaptopropane-1,2-diol
- EC Number:
- 202-495-0
- EC Name:
- 3-mercaptopropane-1,2-diol
- Cas Number:
- 96-27-5
- Molecular formula:
- C3H8O2S
- IUPAC Name:
- 3-sulfanylpropane-1,2-diol
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- purchased from Fluka
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Age: 8-12 wk
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10.0%, 25.0%, 50.0%
- No. of animals per dose:
- 4
- Details on study design:
- Mice received daily topical application for 3 consecutive days with 25 µL of one of three concentrations of the test chemical on the dorsum of each ear. Control mice were treated with vehicle alone in an identical manner. 5 days after the first topical application, all mice were injected iv with 250 µL PBS containing 20 µCi of [³H]methyl thymidine
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- not required
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 3.9
- Test group / Remarks:
- Interpolated from the SI values at 0%, 10%, and 25%
- Key result
- Parameter:
- SI
- Value:
- 6.7
- Test group / Remarks:
- 10.0%
- Parameter:
- SI
- Value:
- 10
- Test group / Remarks:
- 25.0%
- Parameter:
- SI
- Value:
- 10
- Test group / Remarks:
- 50.0%
Any other information on results incl. tables
TG was also positive in 100% of participants in a human maximization test using 10% and 5% TG for induction and challenge, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- TB showed an EC3 of ca. 4%. It is therefore considered a moderate skin sensitizer (Skin Sens 1B).
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