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Toxicological information

Skin sensitisation

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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:
2000
Reference Type:
secondary source
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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 group
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%).