Dioctyltin oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 August 2012 to 27 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed to the standardised guidelines OECD 439 and EU Method B.46 and in line GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dioctyltin oxide

EC Number:

212-791-1

EC Name:

Dioctyltin oxide

Cas Number:

870-08-6

Molecular formula:

C16H34OSn

IUPAC Name:

dioctylstannanone

Details on test material:

- Name of test material (as cited in study report): Di-n-octyltin oxide
- Physical state: white solid
- Storage conditions: room temperature in the dark

Test animals

Details on test animals or test system and environmental conditions:

EPISKIN Model Kit
Supplier: SkinEthic Laboratories, Nice, France

Test system

Amount / concentration applied:

10 mg of the solid test item was applied topically.

Duration of treatment / exposure:

15 minutes

Number of animals:

Not applicable

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: OD540

Value:

0.515

Remarks on result:

other:

Remarks:

Basis: mean triplicate tissues. Time point: 15 minutes. Max. score: 0.567. Remarks: ± SD (0.066). (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: Relative mean viability (%)

Value:

66.7

Remarks on result:

other:

Remarks:

Basis: mean triplicate tissues. Time point: 15 minutes. Max. score: 100.0. Remarks: value in percent (%). ± SD (8.5 %). (migrated information)

Any other information on results incl. tables

Direct MTT Reduction

The MTT solution containing the test material did not turn blue which indicated that the test material did not directly reduce MTT.

Main Test - Results

The relative mean viability of the test material treated tissues was 66.7 % after a 15 minute exposure period

Table 1: Results

Item	OD540 of tissues	Mean OD540 of triplicate tissues	± SD of OD540 Relative individual tissue viability (%)	Relative individual tissue viability (%)	Relative mean viability (%)	± SD of Relaive mean viability (%)
Negative control item	0.748	0.771	0.025	97.0	100*	3.2
	0.769			99.7
	0.797			103.4
Positive control item	0.104	0.079	0.022	13.5	10.2	2.9
	0.07			9.1
	0.062			8.0
Test material	0.567	0.515	0.066	73.5	66.7	8.5
	0.441			57.2
	0.536			69.5

SD = standard deviation

* = the mean viability of the negative control tissues is set at 100 %

Quality Criteria

The relative mean tissue viability for the positive control treated tissues was 10.2 % relative to the negative control treated tissues and the standard deviation value of the percentage viability was 2.9 %. The positive control criterion was therefore satisfied.

The mean OD540 for the negative control treated tissues was 0.771 and the standard deviation value of the percentage viability was 3.2 %. The negative control acceptance criterion was therefore satisfied.

The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 8.5 %. The test material acceptance criterion was therefore satisfied.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was considered to be a 'non-irritant' to the skin.

Executive summary:

The purpose of the test was to evaluate the skin irritation potential of the test material using the EPISKIN in vitro Reconstructed Human Epidermis (RHE) Model. This method was designed to be compatible with the OECD Guideline for the Testing of Chemicals No. 439 “In Vitro Skin Irritation” (adopted 22 July 2010) and Method B.46 of Commission Regulation (EC) No. 440/2008.

 

Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. 

At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre labelled 96 well plate. The optical density (OD) was measured at 540 nm (OD540).

Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).

 

The relative mean viability of the test material treated tissues was 66.7 % after the 15 minute exposure period. The quality control criteria required for acceptance of results in the test were satisfied. Under the conditions of the test, the test material was concluded to be a non-irritant to the skin.