Bis(tributyltin) oxide

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

July 1985 to August 1985

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

unsuitable test system

Remarks:

(the solvent was responsible for the skin reactions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Study type:

human medical data

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

26 male and female test subjects (15 women and 11 men) with healthy skin, aged between 19 and 44 years, were part of a trial to achieve the most realisitic application possible regarding duration and frequency of exposure. It was assumed that persons working with wood preservatives, such as TBTO, come into daily contact with them for a period of 8 hours.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Tributyltin oxide (TBTO)

IUPAC Name:

Tributyltin oxide (TBTO)

Constituent 2

Reference substance name:

21.955

IUPAC Name:

21.955

Details on test material:

LD-162-2 1% tributyltin oxide
TF-0744 Research product, reaction products from TBTO + silica gel type M

Method

Type of population:

general

Ethical approval:

not specified

Remarks:

Subjects were informed orally and in writing of the risks of the trial

Details on study design:

15 women and 11 men with healthy skin, aged between 19 and 44 years, took part in the trial. The following formulations were randomised and applied to test areas and investigated:
LD-162-1: Gasoline 60 + Alkydal F 67 (60%)
LD-162-2: 1% Tributyl tin oxide
TF-0744: Research product, reaction product from TBTO + silica gel type M
TBTO was dissolved in a solution of gasoline 60 and Alkydal F 67 (60%).

Test substances were applied on disks of filter paper (15 mm diameter), affixed with adhesive tap, and placed on the inside of both forearms. The next application was made after an interval of at least 2 days, and the exposure was doubled. The trial was in five parts:
Experiment 1: 30 min
Experiment 2: 1 hour
Experiment 3: 2 hours
Experiment 4: 4 hours
Experiment 5: 8 hours

Part 6 of the tiral was carried out over 6 days with a daily exposure period of 8 hours. Visual assessments were made.
Visual assessement was made after application, and 24 and 48 hours (only in the case of parts 3, 4 and 5) after removal according to the following criteria:

1- no change
2- slight reddening the size of the treated area
3- marked reddening the size of the treated area, or slight swelling extending beyond the treated area
4- marked reddening, moderate swelling
5- marked local skin reaction including blistering

Results and discussion

Results:

Moderal intolerance reactions were observed. Reddening of skin and slight swelling occurred in treated areas. Brief contact of 30 minutes with TBTO did not cause reactions. After 1 hour, in one case a slight reddening was observed at site of application. Reddening was more marked and slight inflammatory swelling was observed. The erythema and swelling lasted for 48 hours for treatments over 2 hours in length. In the case of administration over 5 days, the trial had to be discontinued due to heavy swelling, itching, blistering. Corresponding reactions occurred even after administration of LD-162-1 (the solvent without active ingredient).

Applicant's summary and conclusion

Conclusions:

Moderate intolerance was observed following 2 days' application under realistic conditions of tributyl tin formulations, intended for use in wood preservatives. The tested formulations caused erythema and slight swelling of the skin. These reactions are primarily due to the solvent (gasoline and Aklydal) without active ingredient. Tolerance of the research product dissolved (TF-0744) in water was much better.

Executive summary:

15 women and 11 men with healthy skin, aged between 19 and 44 years, took part in the trial. The following formulations were randomised and applied to test areas and investigated:

LD-162-1: Gasoline 60 + Alkydal F 67 (60%)

LD-162-2: 1% Tributyl tin oxide

TF-0744: Research product, reaction product from TBTO + silica gel type M

Formulations 2-6 were dissolved in a solution of gasoline 60 and Alkdal F 67 (60%).

Test substances were applied on disks of filter paper (15 mm diameter), affixed with adhesive tap, and placed on the inside of both forearms. The next application was made after an interval of at least 2 days, and the exposure was doubled. The trial was in five parts:

Experiment 1: 30 min

Experiment 2: 1 hour

Experiment 3: 2 hours

Experiment 4: 4 hours

Experiment 5: 8 hours

Visual assessement was made after application, and 24 and 48 hours after removal.

Part 6 of the trial was carried out over 6 days with a daily exposure period of 8 hours. Visual assessments were made. Moderate intolerance was observed following 2 days' application under realistic conditions of tributyl tin formulations, intended for use in wood preservatives.

The tested formulations caused erythema and slight swelling of the skin. These reactions were primarily due to the solvent (gasoline and Aklydal) without active ingredient. Tolerance of the research product dissolved (TF-0744) in water was much better.