Registration Dossier
Registration Dossier
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EC number: 500-057-6 | CAS number: 27104-30-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1992-1994
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Evaluated data from a reliable secondary source (WHO 2000 as well as US-CPSC).
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
- EC Number:
- 259-709-0
- EC Name:
- Tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
- Cas Number:
- 55566-30-8
- IUPAC Name:
- bis[tetrakis(hydroxymethyl)phosphonium] sulfate
- Details on test material:
- Name: Tetrakis(hydroxymethyl)phosphonium sulfate (THPS)
Molecular formula: C8H24O12P2S
Structure: [P(Ch2OH)4]2 SO4
Molecular weight: 406.28
Substance type: ionic substance
Physical state: solid
Further details (analytical purity etc): 75% THPS (nominal) aqueous solution
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:
- epicutaneous, semiocclusive
- Vehicle:
- water
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
Results and discussion
- Positive control results:
- THPS (75%) was assessed for skin sensitization using the Magnusson & Kligman Maximisation test (OECD 406). Fourteen out of 20 animals
challenged with the test substance were sensitized (Guest, 1994b). These data clearly demonstrate a sensitization potential for THPS (75%).
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. Group: test group. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: no data.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The data clearly demonstrate a sensitization potential for THPS (75%).
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