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

Eye irritation

Administrative data

Endpoint:

eye irritation: 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: 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

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:

- Name of test material (as cited in study report): PYRIDINIUMSULFONATE

- Substance type: white powder with lumps

- 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 / tissue source

Species:

other: slaughtered cattle which were between 12 and 60 months old

Strain:

not specified

Test system

Vehicle:

physiological saline

Controls:

yes

Duration of treatment / exposure:

1 h

Observation period (in vivo):

4 h

Number of animals or in vitro replicates:

3 bovine corneas were used.

Results and discussion

In vivo

Results

Irritation parameter:

other: IVIS (in vitro irritancy score)

Basis:

mean

Time point:

other: 4h

Score:

0.179

Reversibility:

other: not applicable for this test system

Other effects:

Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea.
20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea.

Any other information on results incl. tables

According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.

The negative or solvent control has to show an IVIS between 0 and 3: 1.818

Values for positive controls were within the range of historical data of the test facility 35.6 -130.4: 91.927

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage (No Category according to UN GHS Category Eye Damage)