Reaction mass of benzene-1,3-disulphonic acid and sulphuric acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-02-12 to 2015-02-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

2015-04-08

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid

Molecular formula:

H2SO4 C6H6O6S2

IUPAC Name:

Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid, aqueous solution

Test system

Details on study design:

Commercially available Corrositex®-Kit.
The test system consists of two components: a proteinaqeous macromolecular gel (=synthetic biobarrier) on a permeable membrane and a fluid, the CDS
(=Chemical Detection System). Corrosive substances are able to penetrate the biobarrier and can enter the CDS.
A colour change is visible due to a pH indicator dye.
The proteinaqeous gel, composed of protein, e.g., keratin, collagen, or mixtures of proteins, forming a gel matrix, serves as the target for the test item.
The proteinaqeous material is placed on the surface of the supporting membrane and allowed to gel prior to placing the membrane barrier over the indicator solution.
The indicator solution responds to the presence of a test item. A combination of pH indicator dyes that will show a colour change in response to the presence of the test item or other types of chemical or electrochemical reactions is used.
The time required for a test item to pass through a biobarrier membrane is inversely proportional to its corrosivity: the more corrosive a substance, the
shorter is the time required to cause a colour change.
Non-corrosive substances do not penetrate the biobarrier at all or too slowly in order to classify them as corrosive according the UN packing groups.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: Break-Through Time

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 539 sec.. Reversibility: no data. Remarks: Corrosive, UN Packing group II; GHS skin corrosion category 1B. (migrated information)

In vivo

Irritant / corrosive response data:

The test item is considered corrosive and has to be classified to UN Packing Group II and GHS skin corrosion category 1B, accordingly.
The measured mean break-through time was 539 sec. (8.98 min).

Other effects:

The negative control showed no break-through and therefore no corrosive effects.
The measured time of the positive control was 12.83 min, thus ensuring the validity of the test system.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP; EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The test item is considered corrosive and has to be classified to UN Packing Group II and GHS skin corrosion category 1B, accordingly.
The measured mean break-through time was 8.98 min.

Executive summary:

Anin vitroMembrane Barrier Test Method for Skin Corrosion was conducted according to OECD guideline 435 with the test item using the Corrositex®- Test.

 

Four vials with a synthetic biobarrier and a CDS (= Chemical Detection System) were treated with 500 µL of the liquid test item

were applied to each biobarrier and observed for possible penetration.

10% Citric acid was used as negative control, NaOH was used as positive control.

The negative control showed no break-through and therefore no corrosive effects, the measured time of the positive control was 12.83 min, thus ensuring the validity of the test system.

 

The test item showed corrosive effects in average after 8.98 minutes.

 

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses skin corrosion potential and is classified as a corrosive substance belonging to UN Packing Group II, GHS classification: skin corrosion category 1B.

Therefore, the test item is considered as corrosive in the Corrositex®- Test.