Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP. Observation period only 7 days.

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
Reference substance name:
2,3,5-trimethylhydroquinone
EC Number:
211-838-3
EC Name:
2,3,5-trimethylhydroquinone
Cas Number:
700-13-0
IUPAC Name:
2,3,5-trimethylbenzene-1,4-diol
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; D-6050 OFFENBACH/MAIN, Germany
- 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; FIRMA KLINGENTALMUEHLE AG, CH-4303 KAISERAUGST, SWITZERLAND (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 2.5x2.5 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)

Mean irritation score was calculated according to 83/467/EEC criteria (1983), using the readings of 24, 48, and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 7 d

Any other information on results incl. tables

Animal1: male, 2.61 kg

Animal 2: male, 2.49 kg

Animal 3: female, 2.82 kg

Results:

Readings Animal Erythema Edema Additional findings
4 h 1 1 0  
2 1 0  
3 1 0  
24 h 1 1 0  
2 2 0  
3 3 1  
48 h 1 0 0  
2 2 0  
3 3 0  
72 h 1 0 0  
2 2 0  
3 2 0  
7 d 1     d
2 0 0 s
3 0 0 s
mean 24 - 72 h 1 0.3 0.0  
2 2.0 0.0  
3 2.7 0.3  
mean 24 - 72 h   1.7 0.1  

d: discontinued due to absence of irritation

s: scaling

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Remarks:
Migrated information