sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt

Skin sensitisation

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1992

Reference 2

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

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

Test material information

Constituent 1

Reference substance name:

Sodium octyl sulphate

EC Number:

205-535-5

EC Name:

Sodium octyl sulphate

Cas Number:

142-31-4

Molecular formula:

C8H18O4S.Na

IUPAC Name:

sodium octyl sulfate

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)

Results

Results 1

Parameter:

SI

Value:

1.25

Remarks on result:

other: 1.25, 2.7 or 3.1

Results 2

Parameter:

SI

Value:

2.7

Results 3

Parameter:

SI

Value:

3.1

Results 4

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.