Registration Dossier
Registration Dossier
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EC number: 284-957-1 | CAS number: 85005-25-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 19. Oct. 2011 - 11. Jan. 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The department of health of the government of the United Kingdom
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol
- EC Number:
- 286-072-6
- EC Name:
- Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol
- Cas Number:
- 85186-86-3
- IUPAC Name:
- 85186-86-3
- Details on test material:
- - Physical state: yellow liquid
- Analytical purity: 91%
- Lot/batch No.: OE10817
- Expiration date of the lot/batch: 21.102016
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand White (Hsdlf:NZW)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.5 to 2.74 kg
- Housing: individually in suspended cages
- Diet: 2930 Teklad Global Rabbit diet (Harlan Laboratories Ltd., oxon, UK)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated site 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:
- initial test: 3 minutes, 1 and 4 hours
confirmatory test: 4 hours - Observation period:
- 7 days
reading time points: 1, 24, 48, 72 hours and 7 days - Number of animals:
- 3 (1 in the initial , 2 in the confirmatory test)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the back of the rabbit
- Type of wrap if used: coton gauze patch secured with a strip of surgical adhesive tape and wrapped in an elastic corset
REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: end of exposure after 3 minutes, 1 or 4 hours
SCORING SYSTEM: Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1 and animal #2
- Time point:
- other: mean over 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1 and animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Very slight erythema was noted at one treated skin site at the 24 h observation with well-defined erythema and very slight oedema noted at the 48 and 72 h observations. No evidence of skin irritation was noted at two treated skin sites during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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