Registration Dossier
Registration Dossier
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EC number: 939-237-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study reasonably well documented, meets generally accepted scientific principles, acceptable for assessment.
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.4
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Alcohols, C6-12
- EC Number:
- 271-642-9
- EC Name:
- Alcohols, C6-12
- Cas Number:
- 68603-15-6
- IUPAC Name:
- octan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Tradename Lial 111 C6-12 alcohols Type A
- Physical state:
- Storage condition of test material:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg
- Housing: stainless steel cages
- Diet: pelleted complete diet
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (+/-2)
- Humidity (%): 55 (+/-15)
- Air changes (per hr): min. 8
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Examination time points: 1, 24, 48 and 72 hours, 5 and 7 days.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6x6cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water or appropriate solvent
- Time after start of exposure: 4h
SCORING SYSTEM:Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 1.5
- Max. score:
- 1.7
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: Individual 24+48+72 hour scores 3 animals scored 2 the remaining 3 scored 1.7. Group mean 24+48+72 hour score 1.83.
- Oedema: Individual 24+48+72 hour scores 3 animals scored 1.3 the remaining 3 scored 1.7. Group mean 24+48+72 hour score 1.5. - Other effects:
- None reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Following a 4 hour occluded exposure to rabbit skin, LIAL 111 (C11) was not a skin irritant according to EU criteria (group mean 24+48+48 hour scores <2). With erythema scores all >=1.5 LIAL 111 is classifiable as a mild (slight) skin irritant according to the GHS.
Classification: not irritating
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