Registration Dossier
Registration Dossier
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EC number: 218-577-4 | CAS number: 2186-92-7
Skin irritation / corrosion
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:
- other: Test protocol equivalent to current test guidelines; non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- p-(dimethoxymethyl)anisole
- EC Number:
- 218-577-4
- EC Name:
- p-(dimethoxymethyl)anisole
- Cas Number:
- 2186-92-7
- Molecular formula:
- C10H14O3
- IUPAC Name:
- 1-(dimethoxymethyl)-4-methoxybenzene
- Details on test material:
- - Name of test material (as cited in study report): p-(dimethoxymethyl)anisole
(Anisacetal KW 7056469-1)
- Substance No.: 84/102
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 2.81 kg
- Housing: single in stainless steel cages with wire mesh walk floors, floor area: 40 x 51 cm
- Diet (e.g. ad libitum): Solikanin 4MM (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: for 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 hours before begin of study
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm on upper third of back or flanks
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutol and Lutrol:water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM:
Evaluation of erythema and edema acc. to 83/467/EEC criteria:
0 = NONE
1 = VERY SLIGHT
2 = WELL-DEFINE D
3 = MODERATE TO SEVERE
4 = SEVERE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
Results:
Animal1: male, 3.1 kg
Animal 2: male, 2.94 kg
Animal 3: 2.4 kg
| Readings | Animal | Erythema | Edema | Additional findings |
| 4 h | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 1 | 0 | ||
| 24 h | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 48 h | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 72 h | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| mean 24 - 72 h | 1 | 0.0 | 0.0 | |
| 2 | 0.0 | 0.0 | ||
| 3 | 0.0 | 0.0 | ||
| mean 24 - 72 h | all animals | 0.0 | 0.0 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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