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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
L-2-hydroxy-2-phenylacetic acid
EC Number:
210-276-6
EC Name:
L-2-hydroxy-2-phenylacetic acid
Cas Number:
611-71-2
Molecular formula:
C8H8O3
IUPAC Name:
L-hydroxy(phenyl)acetic acid; (αR)-α-Hydroxybenzeneacetic acid
Test material form:
solid

In vitro test system

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

Test animals

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:

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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).