Mandelic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 10, 2016 - August 12, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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)

Test material

Test material information

Constituent 1

Reference substance name:

Mandelic acid

EC Number:

202-007-6

EC Name:

Mandelic acid

Cas Number:

90-64-2

Molecular formula:

C8H8O3

IUPAC Name:

hydroxy(phenyl)acetic acid

Test material form:

solid

Specific details on test material used for the study:

Designation: Art. 806913
Synonym: DL-Mandelic acid for synthesis
Appearance: Solid
Minimum shelf life: May 31, 2020
Storage: Tightly closed, dark at room temperature (15 to 25°C)

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

750 µL (i.e. 150mg/750µL) of test item preparation, negative or positive control.

The test item Art. 806913 was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation.

Duration of treatment / exposure:

240 minutes

Number of animals or in vitro replicates:

in vitro: triplicate design

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

Experiment 1 / Run 1

Value:

199.8

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

		Opacity	Permeability	IVIS
				per cornea	per group (mean value)	SD
Negative control	0.9% NaCl Solution	1.487	-0.001	1.477	1.2	1.1
		-0.131	0.002	-0.106
		2.067	0.002	2.102
Positive control	20% Imidazole solution	65.778	2.136	97.811	102.6	10.1
		61.921	2.261	95.834
		77.183	2.470	114.226
Test item	Art. 806913	202.722	0.002	202.745	199.8	6.5
		204.439	-0.003	204.397
		192.282	0.003	192.330

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the conditions of the present study, Art. 806913 is inducing serious eye damage (UN GHS: Category 1).

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. Under the conditions of the present study, Art. 806913 is inducing serious eye damage (UN GHS: Category 1).