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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

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1992
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:
Only limited data on test item and methodology available
Principles of method if other than guideline:
Method: other
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
-Source: Jackson Labs., ME
-Age: ca. 5 weeks
-Weight at study initiation: 12 - 20 g

Study design: in vivo (LLNA)

Vehicle:
other: water
Concentration:
12.5 µl of a 10, 50 or 100% solution
No. of animals per dose:
5
Details on study design:
TREATMENT PREPARATION AND ADMINISTRATION:
-Daily topical application of 12.5 µl of a 10, 50 or 100% solution in dist. water on 4 consecutive days -Ca. 21 hrs. after last treatment the animals were injected i.v. with radiolabeled thymidine. Approximately 5 h after injection the mice were euthanized, the auricular lymph nodes were removed and single cell suspensions were prepared. Cells were washed with phosphate-buffered saline to remove unbound radiolabel, then precipitated with trichloroacetic acid. The total radiolabel incorporation in these precipitates was subsequently quantified by liquid scintillation spectrometry.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.25
Remarks on result:
other: 1.25, 2.7 or 3.1
Parameter:
SI
Value:
2.7
Parameter:
SI
Value:
3.1
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: No data available

Any other information on results incl. tables

The treatment had no significant effect on thymidine incorporation by 

auricular lymph node cells when compared with naive and carrier controls:

stimulation index: 1.25, 2.7 or 3.1
naive control: 2.4
carrier control: 1

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.