Registration Dossier
Registration Dossier
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EC number: 222-048-3 | CAS number: 3327-22-8
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: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.4
- GLP compliance:
- not specified
- Remarks:
- RAR, 2008 and IUCLID indicate GLP compliance, the study report does not.
Test material
- Reference substance name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- EC Number:
- 222-048-3
- EC Name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- Cas Number:
- 3327-22-8
- Molecular formula:
- C6H15ClNO.Cl
- IUPAC Name:
- 3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
- Details on test material:
- IUCLID4 Test substance: other TS: Reagens-S-CFZ (CHPT), 65% 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: Froxfield Rabbits, Petersfield, Hants, UK
- Age at study initiation: 11-12 wk
- Weight at study initiation: 2.4-2.7 kg
- Housing: 1/metal cage with perforated floor
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 3-=70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml CHPTAC 65 % (as supplied)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 4 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 30 mins, days 2, 3, 4
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 4-h exposure
- Irritant / corrosive response data:
- Not irritating
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- A guideline study found the test material (65% aqueous CHPTAC) to be non-irritant when in semi-occluded contact with rabbit skin for 4 h.
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