Registration Dossier
Registration Dossier
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EC number: 616-261-4 | CAS number: 75782-87-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- pentadecan-1-ol; tetradecan-1-ol
- EC Number:
- 616-261-4
- Cas Number:
- 75782-87-5
- Molecular formula:
- C14H30O -C15H32O
- IUPAC Name:
- pentadecan-1-ol; tetradecan-1-ol
- Details on test material:
- Tradename Alchem 145 C14-16 alcohols Type A
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- 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:
- 7 days (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: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.4
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.4
- Max. score:
- 0.7
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- - Erythema: Individual 24+48+72 hour scores 5 rabbits gave a score of 0.3, the remaining rabbit gave a score of 0.7
(group mean 24+48 +72 hour score 0.4)
- Oedema: Individual 24+48+72 hour scores 5 rabbits gave a scores of 0.3, the remaining rabbit gave a score of 0.7
(group mean 24+48 +72 hour score 0.4) - 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 occlusive exposure Alchem 145 was not irritating to rabbit skin when assessed by either EU or GHS criteria. All scores <1.5.
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