Reaction mass of 4-sulfophthalic acid and 3-sulfophthalic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 feb 2017 to 03 May 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

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:

4-sulphophthalic acid

EC Number:

201-881-6

EC Name:

4-sulphophthalic acid

Cas Number:

89-08-7

Molecular formula:

C8H6O7S

IUPAC Name:

4-sulphophthalic acid

Constituent 2

Reference substance name:

3-sulphophthalic acid

EC Number:

267-576-5

EC Name:

3-sulphophthalic acid

Cas Number:

67892-43-7

Molecular formula:

C8H6O7S

IUPAC Name:

3-sulphophthalic acid

Constituent 3

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

In vitro test system

Test system:

artificial membrane barrier model

Remarks:

Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin

Source species:

other: Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin

Vehicle:

unchanged (no vehicle)

Test animals

Species:

other: Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin

Test system

Type of coverage:

other: In vitro

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

Single Exposure

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

1

Value:

ca. 12.26

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

The positive control, 1.0 N Sodium Hydroxide, was categorized as received and the negative control, Citric Acid, was used as a 10% solution in water. The results of both controls were considered valid.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

The material was considered moderately corrosive. The material was classified in Packing Group II of GHS Subcategory 1B.

Executive summary:

The reaction mass of 4- Sulphophthalic acid (CAS 89 -08 -7) and 3- sulphophthalic acid (CAS 67892 -43 -7), 3:1 ratio was determined to be compatible with the Corrositex® system. Then, a formulation of 10% test material in water 100 uL test material : 900 uL tissue culture water) was categorized by pH to determine Category 1 cut-off times should be used to determine corrosivity. 0.5 mL of the test article was added to each of four Corrositex® test vials containing biobarriers and the times required for the test article to permeate or destroy the biobarriers were recorded. A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) was tested concurrently. The average breakthrough time for the four test material samples was 12.26 minutes. The test material was considered moderately corrosive.