Tin, dioctylbis(2,4-pentanedionato-.kappa.O2,.kappa.O4)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

483-270-6

EC Name:

-

Cas Number:

54068-28-9

Molecular formula:

Hill formula: C26H48O4Sn CAS formula: C26H48O4Sn

IUPAC Name:

(3Z)-4-{[dioctyl({[(2Z)-4-oxopent-2-en-2-yl]oxy})stannyl]oxy}pent-3-en-2-one

Details on test material:

TIB KAT 223 Ch. VP10-054

In vivo test system

Test animals

Species:

mouse

Strain:

other: Nulliparous,e CBA/Ca

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

100, 50, 25, 10, 5, 2.5, 0 percent

No. of animals per dose:

4

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 100 v/v % : SI=9.8 50 v/v % : SI=3.3 25 v/v % : SI=6.4 10 v/v % : SI=5.1 5 v/v % : SI=1.2 2.5 v/v % : SI=1.4

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: vehicle M1: DPM=419 100 v/v % : DPM=4089 50v/v % : DPM=1381 25v/v % : DPM=2661 vehicle M2: DPM=159 10v/v % : DPM=814 5v/v % : DPM=180 2.5v/v % : DPM=224

Applicant's summary and conclusion

Interpretation of results:

other: sensitising in concentration >5 v/v %

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

The Local Lymph Node Assay demonstrated that TIB KAT 223 (Tin, dioctylbis(2,4-pentanedionato-κO2,κO4)-) has the potential to cause skin sensitisation at concentrations of 10% v/v and higher. However, at concentrations of 5% and under, TIB KAT 223 (Tin, dioctylbis(2,4-pentanedionato-κO2,κO4)-) does not cause skin sensitisation.

Executive summary:

This study was conducted to assess the potential of the test article, TIB KAT 223 (Tin, dioctylbis (2,4-pentanedionato-O,O’)-), to cause skin sensitisation in the mouse.

Following a preliminary screening test using the undiluted test article, the test article was prepared for administration at 2.5, 5, 10, 25 and 50% in DMSO together with undiluted test article. Groups of four female CBA / Ca mice were subjected to topical applications of vehicle or of one of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6 a 20 μCi dose of tritiated³H-methyl thymidine was injected intravenously into each mouse. Five hours later the auricular lymph nodes were recovered from each animal. The nodes from mice subjected to the same treatment were pooled and suspensions of the cellular components of the lymph nodes were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter.

Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.

	Concentration of test article in applied formulation(% v/v)
	25%	50%	100%
Stimulation Index	6.4	3.3	9.8

The stimulation indices were above the threshold level of 3.0, therefore an additional phase was performed at the request of the Sponsor. In the additional phase, the test article was prepared for administration at 2.5, 5 and 10% in DMSO.

	Concentration of test article in applied formulation(% v/v)
	2.5%	5%	10%
Stimulation Index	1.4	1.2	5.1

The EC3 value for TIB KAT 223 (Tin, dioctylbis (2,4-pentanedionato-O,O’)-) was 7.3.

The Local Lymph Node Assay demonstrated that TIB KAT 223 (Tin, dioctylbis (2,4-pentanedionato-O,O’)-) has the potential to cause skin sensitisation.

The EC3 value estimates that at concentrations above 7.3% v/v the test article would elicit skin sensitisation.

The test article was classified as a Category 1 sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).