Registration Dossier
Registration Dossier
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EC number: 202-443-7 | CAS number: 95-71-6
Skin irritation / corrosion
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:
- 1 990
- 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
- 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
Constituent 1
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
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