Registration Dossier
Registration Dossier
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EC number: 214-317-9 | CAS number: 1120-71-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact Hypersensitivity and Sensitizing Mechanism of the Sultones Contaminated in Alkyl Ethoxy Sulfate Products
- Author:
- Morikawa, J. et al.
- Year:
- 1 978
- Bibliographic source:
- Japanese Journal of Allergology 27(7), 648-661
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- 1,3-propanesultone
- EC Number:
- 214-317-9
- EC Name:
- 1,3-propanesultone
- Cas Number:
- 1120-71-4
- Molecular formula:
- C3H6O3S
- IUPAC Name:
- 1,2λ⁶-oxathiolane-2,2-dione
- Details on test material:
- no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Induction: FCA (intradermal), liquid paraffin (epicutaneous)
- Concentration / amount:
- Intradermal induction: 1% in FCA
Epicutaneous induction: 1% in liquid paraffin - Day(s)/duration:
- 1 single injection and after one week 48 h epicutaneous occlusive application
- Adequacy of induction:
- not specified
Challenge
- Route:
- other: epicutaneous, closed patch or open application
- Vehicle:
- other: EtOH
- Concentration / amount:
- Epicutaneous challenge: 2% and 0.1% in EtOH
- Day(s)/duration:
- two weeks after epicutaneous induction for 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 1 single injection and after one week 48 h epicutaneous occlusive application
- Test groups: injection: 0.1 mL FCA, 0.1 mL test substance, 0.1 mL test substance in FCA, epicutaneous: in petrolatum
- Control group: injection: 0.1 mL FCA, 0.1 mL vehicle, 0.1 mL vehicle in FCA, epicutaneous: in petrolatum
- Site: rectangle area (scapular region)
- Frequency of applications: one application each
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: two weeks after epicutaneous induction
- Exposure period: 24 h
- Test groups and control group: closed patch or open epicutaneous
- Site: back
- Evaluation (hr after challenge): 24 h and 48 h - Challenge controls:
- no
- Positive control substance(s):
- yes
- Remarks:
- test included various 1-alkyl-1,3-propione sultones
Results and discussion
- Positive control results:
- The 1-alkyl-1,3-propane sultones tested concurrently were positive, indicating the sensitivity of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: only combined reading (24 h and 48 h) reported
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: only combined reading (24 h and 48 h) reported
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- other: only combined reading (24 h and 48 h) reported
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: only combined reading (24 h and 48 h) reported
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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