Registration Dossier
Registration Dossier
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EC number: 608-307-7 | CAS number: 2901-13-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of study: August 26 - End of study: August 29, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Principles of Good Laboratory Practice, annex of paragraph 19a, section 1 of the chemical law of July 25, 1994
Test material
- Reference substance name:
- α,α-Dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 608-307-7
- Cas Number:
- 2901-13-5
- Molecular formula:
- C12 H16 O2
- IUPAC Name:
- α,α-Dimethyl-ethyl ester benzeneacetic acid
- Details on test material:
- Name: Dimethylphenylessigsäureethylester
Synonyms: EDMPA
Chemical name: Benzeneacetic acid, α,α-dimethyl-, ethyl ester
Certificate of analysis: March 18, 1997
Purity: 99.8%
Appearance: clear, colorless liquid
Solubility: 0.3 g/L in water, miscible with alcohol, acetone and toluene
Batch number: B 0006
Date of production: March 12, 1997
Date of expiry: March, 2000
Storage conditions: darkness at approximately 5°C in a refrigerator
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.4-3.8 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333) and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml/patch
- Duration of treatment / exposure:
- 4h
- Observation period:
- Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm²
- Type of wrap if used: 2.5 cm x 2.5 cm cellulose patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with warm tap water
- Time after end of exposure: 30 min
SCORING SYSTEM: Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, the substance is not irritating to skin.
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