Mandelic acid

Endpoint summary

Description of key information

in vitro data

OECD 439: irritant

OECD 431: corrosive

in vivo data

Read Across OECD 404: negative

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

non GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Details on animal used as source of test system:

SOURCE ANIMAL
- Source: Gaukler, Offenbach, Germany
- Sex:male
- Housing:stainless stell cage with wire mesh walk floors, floor area: 40x51 cm
- Diet (e.g. ad libitum): Kliba 341, 4 MM (Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water (e.g. ad libitum):about 250 mL tap water per day
- Acclimation period:at least 8 days before the beginning of the study

Vehicle:

water

Control samples:

other: untreated skin of the same animal served as control

Amount/concentration applied:

THE TEST PATCH (2.5 CM X 2.5 CM) WAS COVERED WITH AN APPROX. 0.5 MM LAYER OF AN 80% SUSPENSION (THUS ABOUT 0.5 G OF THE SUSPENSION WAS APPLIED

Duration of treatment / exposure:

4 h

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, FRG
- Age at study initiation:
- Weight at study initiation: 2.71 kg
- Housing: single in CAGE MADE OF STAINLESS STEEL WITH WIRE MESH WALK FLOORS, FLOOR AREA: 40 CM X 51 CM
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 h

IN-LIFE DATES: From: To:

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

0.5 g of an 80% aqueous suspension on 2.5 cm x 2.5 cm area

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 (m)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100 %
- Type of wrap if used: FOUR LAVERS OF ABSORBENT GAUZE + PORGUS BANDAGE).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposusure period with Lutrol and Lutrol/water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 4, 24, 48, 72 h after application

SCORING SYSTEM:
- Method of calculation: erythema and edema scores, calculation according toi 83/467/EEC criteria

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 4h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Other effects:

no other effects have been observed

Interpretation of results:

GHS criteria not met

Conclusions:

This OECD 404 compliant assay shows no irritation to skin after 4 h exposure of a test material suspension (80 % in water).

Executive summary:

This OECD 404 compliant assay shows no irritation to skin after 4 h exposure of a test material suspension (80 % in water).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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)

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)

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

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

		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

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

For this endpoint information from a structural similar compound is available. The study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 404. The test material was the enantiomer of mandelic acid providing highest simlarity in terms of chemical, biological and physicochemical parameters. Therefore using the in vivo data of the enantiomer for the racemic mixture is justified.

Justification for classification or non-classification

For this endpoint in vivo data are available. In this in vivo study perfomred for the enantiomer no indication for irritation was demonstrated. Therfore, the in vitro findings are considered not relevant for the in vivo situation and no classification is warranted.