Diammonium decaborate

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions.

Data source

Reference

Reference Type:

publication

Title:

Effects of single and repeated exposure to biocidal active substances on the barrier function of the skin in vitro.

Author:

Buist HE, van de Sandt JJM, van Burgsteden JA & de Heer C

Year:

2005

Bibliographic source:

Regulatory Toxicology and Pharmacology 43: 76 – 84.

Materials and methods

Type of study / information:

The influence of repeated and single exposure to boric acid on the skin barrier was investigated in vitro using static diffusion cells from cryopreserved human abdominal skin from 7 female donors.

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The influence of repeated and single exposure to boric acid on the skin barrier was investigated in vitro using static diffusion cells from cryopreserved human abdominal skin from 7 female donors. The dermis was partially removed using forceps and scissors and the average skin thickness was 0.702 ± 0.062 mm. The skin preparations were exposed to 10 μL/cm2 of a solution of boric acid for 4 h (single exposure) starting 4 h after the onset of the experiment or for 3 times 4 h (repeated exposure, starting at 0, 24 and 48 h respectively). The test material was tested at 3 concentrations, representing the range of concentration in which it may be present in products. Each exposure period was finished by washing off the test substance using 4 cotton swabs humidified with 3 % Teepol solution and subsequently drying the skin preparations using 2 dry cotton swabs. The same procedure was applied ot the control skin. All skins were washed three times in order to control fora a possible effect of the washing procedure on skin permeability. For each concentration the single and multiple dosing experiments were always performed with skin from the same donor wiht controls performed in parallel. The integrity of the skin preparations were assessed prior to the start of the experiment by determining the permeability coefficient (Kp) of tritiated water. In addition [14C]propoxur was used as a marker of skin permeability by applying at the end of the exposure period. During the following 3 h samples of receptor fluid were collected for every hour and assayed for tritated water and 14C-radioactivity by liquid scintillation counting. Fluid was replaced by adding fresh receptor fluid after each sampling and the amound of radiolabelled marker molecules that had penetrated the skin was plotted against time.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Boric acid

EC Number:

233-139-2

EC Name:

Boric acid

Cas Number:

10043-35-3

Molecular formula:

H3BO3

IUPAC Name:

Boric acid

Details on test material:

- Name of test material: Boric acid
- Analytical purity: > 99 %

Results and discussion

Any other information on results incl. tables

No clear and constant effect was noted on skin barrier function following boric acid application.

Applicant's summary and conclusion

Conclusions:

The influence of repeated and single exposure to boric acid on the skin barrier was investigated in vitro using static diffusion cells from cryopreserved human abdominal skin from 7 female donors. No clear and constant effect was noted on skin barrier function following boric acid application.