1-Propanesulfonic acid, 3-(cyclohexylamino)-2-hydroxy-, sodium salt (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study according to OECD Test Guideline 431

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

yes

Remarks:

typing error and change of batch (not impacting the study outcome)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

sodium 3-(cyclohexylamino)-2-hydroxypropane-1-sulfonate

EC Number:

700-631-8

Cas Number:

102601-34-3

Molecular formula:

C9 H19 N O4 S . Na

IUPAC Name:

sodium 3-(cyclohexylamino)-2-hydroxypropane-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): CAPSO sodium salt
- Substance type: organic
- Physical state: white crystalline powder
- Analytical purity: 100%
- Impurities (identity and concentrations): none
- Composition of test material, percentage of components: 100% of 3-(Cyclohexamino)-2-hydroxy-1-propanesulfonic acid (Sodium salt)
- Lot/batch No.: SLBB0026V
- Expiration date of the lot/batch: November 30, 2016
- Storage condition of test material: at room temperature

Test animals

Species:

other: reconstituted human skin

Strain:

other: not applicable

Details on test animals or test system and environmental conditions:

not applicable

Test system

Type of coverage:

not specified

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg per epidermis unit

Duration of treatment / exposure:

4 hours

Observation period:

not applicable

Number of animals:

not applicable

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
After the incubation time the EPISKIN-SM units were and rinsed thoroughly with PBS 1x solution to remove the test item from the epidermal surface. The rest of the PBS was removed from the epidermal surface with suitable pipette tip linked to a vacuum source (care was taken to avoid the damage of epidermis).

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: % viability

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 4h. Reversibility: other: not applicable. Remarks: mean % viability: 82%. (migrated information)

In vivo

Irritant / corrosive response data:

% viability of duplicates were 73% and 91%

Other effects:

none

Any other information on results incl. tables

The negative and positive controls were valid.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In the in vitro EPISKIN model test with CAPSO sodium salt the results indicated that the test item is not corrosive to skin.

Executive summary:

Disks of EPISKIN (two units / chemical) were treated with CAPSO sodium salt and incubated for 4 hours at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively. For each treated tissue viability was expressed as a % relative to negative control. The test item is considered to be non-corrosive to skin, if the mean relative viability after 4 hours of exposure is above or equal 35 % of the negative control. CAPSO sodium salt did not showed significantly reduced cell viability in comparison to the negative control after four hours of exposure. Both individual tissue viabilities were above 35 % of the mean negative control value. The average test item treated tissue viability was 82 %. Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid. In conclusion, in this in vitro EPISKIN model test with CAPSO sodium salt the results indicated that the test item is not corrosive to skin.