4-(vinyloxy)butan-1-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation, other

Remarks:

in vivo study already available

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

4-(vinyloxy)butan-1-ol

EC Number:

241-793-5

EC Name:

4-(vinyloxy)butan-1-ol

Cas Number:

17832-28-9

Molecular formula:

C6H12O2

IUPAC Name:

4-(ethenyloxy)butan-1-ol

Details on test material:

Purity: 99.4 %

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

unchanged (no vehicle)

Concentration:

25 µl of undiluted test substance

No. of animals per dose:

5

Details on study design:

The study was performed as a limit test using 1 test group and 1 control group. Each test animal was applied with 25 μL per ear of the undiluted test substance to the dorsum of both ears for three consecutive days. Three days after the last application the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μL of sterile saline into a tail vein. About 5 hours after the 3H-thymidine injection, the mice were sacrificed and the auricular lymph nodes were removed. The weights of each animal’s pooled lymph nodes were determined. Thereafter lymph nodes were pooled group wise and further evaluated by measuring their cellular content and 3H-thymidine incorporation into the lymph node cells (indicators of cell proliferation). Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and for each test group the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation.

Results and discussion

In vivo (LLNA)

Results

Key result

Parameter:

SI

Value:

1.27

Test group / Remarks:

undiluted test substance

Any other information on results incl. tables

Test group	Treatment	Cell Count Stimulation Index	³H-thymidine incorporation Stimulation Index	Lymph Node Weight Stimulation Index	Ear Weight Stimulation Index
1	untreated	1.00	1.00	1.00	1.00
2	undiluted test substance	1.27	1.69	1.23	1.05

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Executive summary:

No signs of systemic toxicity were noticed. When applied undiluted, the test substance did not induce a biologically relevant response (no increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts. There was no relevant increase in lymph node weights, as well. Concomitantly, the increase of 3H-thymidine incorporation into the cells was not biologically relevant (no increase above the cut off stimulation index of 3). The test substance caused some increase in ear weights as indication of ear skin irritation. Thus it is concluded that 4 -(vinyloxy)butan-1 -ol does not show a skin sensitising effect in the Murine Local Lymph Node Assay under the test conditions chosen.