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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment Adopted according to OECD SIDS or other official EU regulation procedures (public available peer reviewed source).

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
A sensitive mouse lymph node assay with two application phases for detection of contact allergens.
Author:
Ikarashi, Y. et al.
Year:
1993
Bibliographic source:
Arch Toxicol 67, 629 - 636
Reference Type:
secondary source
Title:
SIDS Category of Alkyl sulfates, Alkane sulfonates and Alpha-olefin sulfonates
Author:
OECD
Year:
2007
Bibliographic source:
UNEP Publications

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
e.g. limited data on test substance available, only 3 insead of 4 animals per group
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): No data- Physical state: No data- Analytical purity: No data- Lot/batch No.: No data- Storage condition of test material: No data

In vivo test system

Test animals

Species:
mouse

Study design: in vivo (LLNA)

No. of animals per dose:
3

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
0.73
Test group / Remarks:
Daily topical application of 25 µl of a 5% solution.
Parameter:
SI
Value:
1.61
Test group / Remarks:
Daily topical application of 25 µl of a 10% solution.
Parameter:
SI
Value:
1.13
Test group / Remarks:
Daily topical application of 25 µl of a 25% solution.
Parameter:
SI
Value:
1.58
Test group / Remarks:
Intradermal injection of 50 µL of a 0.05% solution in  saline; after 5 days daily topical application of 25 µL of a 5% solution.
Parameter:
SI
Value:
1.93
Test group / Remarks:
Intradermal injection of 50 µL of a 0.5% solution in  saline; after 5 days daily topical application of 25 µL of a 5% solution.
Parameter:
SI
Value:
1.48
Test group / Remarks:
Intradermal injection of 50 µL of a 5% solution in  saline; after 5 days daily topical application of 25 µL of a 5% solution.

Any other information on results incl. tables

Stimulation indices: a.) 0.73, 1.61 and 1.13; b.) 1.58, 1.93 or 1.48

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met