Registration Dossier
Registration Dossier
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EC number: 225-733-5 | CAS number: 5039-78-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15/05/1985-18/05/1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [2-(methacryloyloxy)ethyl]trimethylammonium chloride
- EC Number:
- 225-733-5
- EC Name:
- [2-(methacryloyloxy)ethyl]trimethylammonium chloride
- Cas Number:
- 5039-78-1
- Molecular formula:
- C9H18NO2.Cl
- IUPAC Name:
- Trimethyl((2-[(2-methylprop-2-enoyl)oxy]ethyl))azanium chloride
- Details on test material:
- - Name of test material (as cited in study report): Madquat 80 MC
- Physical state: liquid
- Analytical purity: not determined
- Impurities (identity and concentrations): not determined
- Composition of test material, percentage of components: 100%
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: at ambient temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University (School of Agriculture, Sutton Bonington, Leics., UK)
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.46-2.58 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): 50-55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15.05.198 To: 18.05.1985
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Total quantity applied: 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1h, 24 h, 48 h and 72 hours after the patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: elasticated corset
REMOVAL OF TEST SUBSTANCE: residual is wiped with a cotton wool soaked in water.
SCORING SYSTEM: Draize's score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect observed
- Irritant / corrosive response data:
- Neither erythema nor oedema were observed at any examination time.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, MADQUAT MC 80 is not irritating to the skin of the rabbit.
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