Dibutylbis(dodecylthio)stannane

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23rd to 25th August 2010

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 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dibutylbis(dodecylthio)stannane

EC Number:

214-688-7

EC Name:

Dibutylbis(dodecylthio)stannane

Cas Number:

1185-81-5

Molecular formula:

C32H68S2Sn

IUPAC Name:

dibutylbis(dodecylsulfanyl)stannane

Details on test material:

Identity Provided by Test Article: Dabco T120 Catalyst
Batch No.: 817231
Date Received: 08/13/10
Storage: Room temperature and humidity
Description: Clear liquid
Sample Preparation: Used as received

In vitro test system

Test system:

artificial membrane barrier model

Source species:

other: artificial membrane barrier model

Cell type:

other: artificial membrane barrier model

Cell source:

other: artificial membrane barrier model

Source strain:

other: not applicable, artificial membrane barrier model

Vehicle:

unchanged (no vehicle)

Amount/concentration applied:

150 µl

Duration of treatment / exposure:

The Corrositex® test predicts the in vivo corrosive potential of a chemical compound or mixture by using as an endpoint the amount of time it takes for a chemical to permeate through or destroy a synthetic biobarrier.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: Mean breakthrough time (minutes)

Run / experiment:

mean

Value:

> 120

Remarks on result:

other: The results obtained from the evaluation of four replicate tests demonstrated that a mean time of >1 20.0 minutes was required to destroy the synthetic biobarriers.

Any other information on results incl. tables

The test article was analyzed using the Corrositex® test method to determine its dermal corrosivity potential and U.N. Packing Group classification. The 1.0 N sodium hydroxide positive control had a

breakthrough time of 18.0 minutes, which fell within the range allowed (13.4 and <22.2 minutes). The results of this study indicated that the test article was compatible with the Corrositex® system and

was determined to be a Category 2 material. The results obtained from the evaluation of four replicate tests demonstrated that a mean time of >120.0 minutes was required to destroy the synthetic biobarriers. These findings lead to the classification of this test article as a Non-Corrosive material.

Table 2. Categorization results

Concentration tested       100%

Color in Tube A              None

Color in Tube B              Green*

Category                         2

* = confirm reagent added

Table 3. Classification results

Replicate Breakthrough time (minutes)

#1       >120

#2       >120

#3       >120

#4       >120

Mean   >120

Packing group              Non-corrosive

Corrosivity                   Non-corrosive

Applicant's summary and conclusion

Interpretation of results:

other: Non-Corrosive Criteria used for interpretation of results: other: U.N. Packing Group classification

Conclusions:

The results obtained from the evaluation of four replicate tests demonstrated that a mean time of >120.0 minutes was required to destroy the synthetic biobarriers.

Executive summary:

The test article was qualified, categorized, and found to be compatible with the Corrositex® test system. 500 μl of the test article were then added to the Corrositex® test vials containing biobarriers and the

time required for the test material to destroy the biobarrier was recorded. The positive control (500 μl 1.0 N sodium hydroxide) was also tested. The mean breakthrough time, which predicts the in vivo corrosive potential of the test material, was used to designate the United Nations (U.N.) Packing Group classification.

The results obtained from the evaluation of four replicate tests demonstrated that a mean time of >120.0 minutes was required to destroy the synthetic biobarriers. These findings lead to the classification of this test article as a Non-Corrosive material.