Pyridinium, 3-[(diethylamino)carbonyl]-1-(3-sulfopropyl)-, inner salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2014 - Aug 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

LAUS GmbH Auf der Schafweide 20 D-67489 Kirrweiler

Test material

Test material information

Constituent 1

Reference substance name:

3-(diethylcarbamoyl)-1-(3-sulfonatopropyl)pyridin-1-ium

EC Number:

807-112-6

Cas Number:

1393708-17-2

Molecular formula:

C13H20N2O4S

IUPAC Name:

3-(diethylcarbamoyl)-1-(3-sulfonatopropyl)pyridin-1-ium

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Analytical purity: 99.8 % (HPLC)

- Composition of test material, percentage of components: Pure substance

- Lot/batch No.: CHZT000001

- Expiration date of the lot/batch: Feb. 2016

- Storage condition of test material: min. - 5 °C - max. +40 °C

Test animals

Species:

human

Strain:

not specified

Test system

Type of coverage:

open

Preparation of test site:

other: tissues of the human skin model EpiDermTM

Vehicle:

other: solid test item (wetted with 25 μL DPBS-buffer)

Controls:

yes

Duration of treatment / exposure:

60 min

Observation period:

measurement directly following after treatment

Number of animals:

Three tissues of the human skin model EpiDerm

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: % Formazan production

Value:

109.9

Remarks on result:

other:

Remarks:

Basis: mean. Time point: after treatment. Reversibility: other: not applicable for human skin model EpiDerm. (migrated information)

In vivo

Other effects:

After treatment with the negative control DPBS-buffer, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8. The positive control 5 % SDS-solution showed clear irritating effects. Variation within tissues was acceptable (< 18%).

Any other information on results incl. tables

Values for negative control and for positive control were within the range of historical data of the test facility.Therefore, the experiment is considered valid.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Skin irritation potential of the test item is assessed as non skin irritant as the Formazan production is >50% of negative control. Therefore, no category for skin irritation according to GHS classification.