Ethanesulfonic acid, 2,2'-(hydroxyimino)bis-, sodium salt (1:2)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed and reported GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

407-370-6

EC Name:

-

Cas Number:

133986-51-3

Molecular formula:

(C2H4SO3Na)2-N-OH

IUPAC Name:

disodium 2-[N-hydroxy-N-(2-sulfonatoethyl)amino]ethane-1-sulfonate

Test material form:

liquid

Test animals

Species:

other: in vitro

Details on test animals or test system and environmental conditions:

Test system: EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 12-EKIN-031).
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.

Rationale: In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).

Source: SkinEthic Laboratories, Lyon, France.

Test system

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

The liquid test substance was applied undiluted (25 µl) directly on top of the tissue.

Duration of treatment / exposure:

See below

Observation period:

Not applicable

Number of animals:

Not applicable

Details on study design:

See below

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

>= 112

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table 1 - Mean absorption in the in vitro skin irritation test

	A (OD570)	B (OD570)	C (OD570)	Mean (OD570)		SD
Negative control	0.883	1.018	0.969	0.957	±	0.069
sample	1.228	0.957	1.029	1.071	±	0.141
Positive control	0.029	0.035	0.044	0.036	±	0.007

OD = optical density

SD = Standard deviation

Triplicate exposures are indicated by A, B and C.

In this table the values are corrected for background absorption (0.042). Isopropanol was used to measure the background absorption.

Table 2 - Mean tissue viability in thein vitroskin irritation test

	Mean tissue viability (percentage of control)
Negative control	100
sample	112
Positive control	4

 

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not irritating in an in vitro test (OECD 439).

Executive summary:

substance is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.