sodium 4-[(4-chlorobenzoyl)amino]benzoate

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

sodium 4-[(4-chlorobenzoyl)amino]benzoate

EC Number:

807-461-4

Cas Number:

1489170-67-3

Molecular formula:

C14H9ClNNaO3

IUPAC Name:

sodium 4-[(4-chlorobenzoyl)amino]benzoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Storage condition of test material: room temperature in the dark
- Description: white powder

Test animals / tissue source

Species:

other: cattle (freshly isolated bovine cornea)

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: from a local abattoir as a by-product from freshly slaughtered animals
- Age at study initiation: typically 12 to 60 months old

Test system

Vehicle:

physiological saline

Controls:

other: yes, concurrent vehicle (negative control) and Imidazole as a 20% w/v solution in 0.9% w/v sodium chloride solution (positive control)

Amount / concentration applied:

The test item was applied at a concentration of 20% w/v in 0.9% w/v sodium chloride solution

Duration of treatment / exposure:

240 min

Observation period (in vivo):

observation immediately after incubation

Number of animals or in vitro replicates:

3 corneae / group

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: rinse off with Eagle's Minimum Essential Medium (MEM) without phenol red
- Time after start of exposure: 240 min

SCORING SYSTEM: In vitro Irritancy Score (according to OECD 437)

TOOL USED TO ASSESS SCORE: opacitometer, fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

other: IVIS (In Vitro Irritancy Score)

Score:

7.2

Remarks on result:

other: the test item is not serious eye damaging (CLP/EPA/GHS (Cat 1)) but no prediction of eye irritation can be made (GHS)

Applicant's summary and conclusion

Interpretation of results:

other: not serious eye damaging (CLP/EPA/GHS (Cat 1))

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

A reliability of Klimisch 1 has been assigned as the study was conducted under GLP according to OECD guideline 437 on the registered substance itself without deviations. The method is to be considered scientifically reasonable. Hence, the results can be considered in general as reliable to assess the eye irritating properties of the test item. According to the current study and under the experimental conditions reported, the substance is not serious eye damaging (CLP/EPA/GHS (Cat 1)) but a prediction for the eye irritation cannot be made (IVIS = 7.2).