Salicylamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 June 2010 - 17 June 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, no restrictions, fully adequate for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 437 (adopted 7 September 2009)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Salicylamide

EC Number:

200-609-3

EC Name:

Salicylamide

Cas Number:

65-45-2

Molecular formula:

C7H7NO2

IUPAC Name:

salicylamide

Constituent 2

Reference substance name:

benzamide, 2-hydroxy

IUPAC Name:

benzamide, 2-hydroxy

Details on test material:

- Physical state: white powder
- Purity test date: 11 March 2010
- Expiration date of the lot/batch: end of March 2012
- Stability under test conditions: confirmed
- Storage condition of test material: <30°C

Test animals / tissue source

Species:

other: in vitro study using excised bovine corneas

Strain:

other: not applicable

Details on test animals or tissues and environmental conditions:

not applicable

Test system

Vehicle:

other: 0.9% sodium chloride solution

Controls:

other: 3 corneas used with negative control (0.9% sodium chloride solution) and 3 with a positive control (20% w/v imidazole).

Amount / concentration applied:

750 µL

Duration of treatment / exposure:

Assessment of corrosivity/severe irritation: 4 hour incubation. Permeability endpoint additional incubation for 1.5 hours ± 5 minutes

Observation period (in vivo):

not applicable

Number of animals or in vitro replicates:

3 corneas per treatment (test, positive and negative control)

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

24.69

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: did not cause corrosion or severe irritation

Any other information on results incl. tables

Corneal opacity, permeability and in vitro irritation scores

Chemical	mean corneal opacity	Permeability		IVS score
		mean negative control corrected optical density	average group corrected optical density
test substance	-1.7	n/a	1.7593	24.69
negative control	0.0	0.0240	0.0000	0.00
positive control	72.7	n/a	-0.0053	72.62

Applicant's summary and conclusion

Interpretation of results:

other: does not cause corrosion or severe irritation

Remarks:

Criteria used for interpretation of results: other: OECD

Conclusions:

The substance was considered not to cause corrosion or severe irritation to the eye under the conditions of the assay.

Executive summary:

A volume of 750 µL of salicylamide formulation, negative control (0.9% sodium chloride solution) or positive control (20% w/v imidazole) was applied to each of three excised bovine corneas followed by a 4 hour incubation at 32°C. After this incubation, each cornea was washed with media containing phenol red followed by media without phenol red, the opacities measured and then the anterior chamber emptied. For the permeability endpoint, sodium fluorescein solution was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and three 200 μL aliquots of this media (per cornea) were analysed for optical density at 490 nanometers.

The salicylamide formulation produced an In Vitro Irritation Score of 24.69.

The positive control article produced an In Vitro Irritation Score of 72.62.

Salicylamide was considered not to cause corrosion or severe irritation to the eye under the conditions of the assay.