Registration Dossier
Registration Dossier
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EC number: 288-342-9 | CAS number: 85711-80-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 19 Oct - 3 Nov 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (limited report)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Colour: light straw
- Analytical purity: 99%
- Lot/batch No.: REF 17727/6
- Storage condition of test material: 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: Charles River UK Ltd, Manston Rd, Margate, Kent or Interfauna UK Ltd, Abbotts Ripton Road, Wyton, Huntingdon, Cambridgeshire, UK
- Diet: Standard Rabbit Diet (Stanrab SQC), SDS Diet Services Limited, UK
- Water: mains
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the left flank
- Type of wrap if used: the treated skin was covered with surgical gauze, held in place with dressing consisting of rubber secured with polyethylene tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed with water or an appropriate solvent
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: other: not applicable
- Irritant / corrosive response data:
- No signs of erythema or edema were observed in the animals during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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