Registration Dossier
Registration Dossier
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EC number: 256-176-6 | CAS number: 44992-01-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23/11/2000-26/112000
- 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:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- [2-(acryloyloxy)ethyl]trimethylammonium chloride
- EC Number:
- 256-176-6
- EC Name:
- [2-(acryloyloxy)ethyl]trimethylammonium chloride
- Cas Number:
- 44992-01-0
- Molecular formula:
- C8H16NO2.Cl
- IUPAC Name:
- Trimethyl[2-(prop-2-enoyloxy)ethyl]azanium chloride
- Details on test material:
- - Name of test material: ADAMQUAT MC 80
- Lot/batch No: A1194bis
- Source: Elf Atochem (Villers St Paul)
- Purity: 80% (aqueous solution)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel, France)
- Weight at study initiation: 2.6 +/- 0.1 kg
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (Total quantity applied): 0.5 mL
- Administration frequency: once
TEST MATERIAL
- Amount applied : 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after the patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: right flank
REMOVAL OF TEST SUBSTANCE
- Washing : no
SCORING SYSTEM: Draize's score
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- Draize's score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours after the patch removal
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days for 2 animals and 6 days for one animal
- Irritant / corrosive response data:
- Neither erythema nor oedema were noted in any animals at any examination time.
- Other effects:
- No other cutaneous reactions were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- ADAMQUAT MC 80 is not irritating to rabbit skin.
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