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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
study according to guideline without GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

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:
2,3,5-trimethylhydroquinone
EC Number:
211-838-3
EC Name:
2,3,5-trimethylhydroquinone
Cas Number:
700-13-0
Molecular formula:
C9H12O2
IUPAC Name:
2,3,5-trimethylhydroquinone
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 2,3,6-trimethylhydroquinone
- Batch: Feb. 20, 1990

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: GAUKLER
- Weight at study initiation: mean 2.55 kg (male), 2.85 kg (female)
- Housing: stainless stell cages with wire mesh floor (area 40 cm x 51 cm)
- Diet (e.g. ad libitum): 4 MM; (ABOUT 130 G PER ANIMAL PER DAY)
- Water (e.g. ad libitum): ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/ 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped at least 15 h before beginning of study
Vehicle:
other: the test material was moistened with water for better application
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 h
Observation period:
8 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: area of 2.5 x 2.5 cm; upper third of the back or flanks
- Type of wrap if used: TEST PATCHES WERE SECURED IN POSITION WITH A POROUS DRESSING (FOUR LAYERS OF ABSORBENT GAUZE + POROUS BANDAGE) .

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol:water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM:
Erythema:
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet-redness) to slight, eschar formation (injuries in depth)

Edema:
0 = No edema
1 = Very slight edema (barely perceptible)
2 = Slight edema (edges of area well defined by definite raising)
3 = Moderate edema (raised approx. 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Animal 1: male, 2.61 kg

Animal 2: male, 2.49 kg

Animal 3: female, 2.82 kg

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
During the test period irritations for trimethylhydroquinone on Vienna White rabbits were observed. Therefore, trimethylhydroquinone is classified as irritating to the skin acc. to CLP-regulation.
Executive summary:

In a study according to OECD Test No. 404 (Acute dermal Irritation/corrosion) the skin irritation potential of trimethylhydroquinone was evaluated in Vienna White rabbits.

Application of 500 mg trimethylhydroquinone was made semiocclusively. Skin reactions were observed within 72 hours.

Due to mean erythema scores (24 h - 72h) >= 2, the test substance is to be classified as skin irritant according to CLP criteria.