Registration Dossier
Registration Dossier
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EC number: 604-580-1 | CAS number: 147256-33-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 16 Dec 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
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, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane
- EC Number:
- 604-580-1
- Cas Number:
- 147256-33-5
- Molecular formula:
- unspecified
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain (as specified by author): Hsdlf:NZW
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.40-2.84 kg
- Housing: individually in suspended cages with environmental enrichment items
- Diet: ad libitum, 2930 Teklad Global Rabbit diet (Harlan Laboratories Ltd., Oxon, UK)
- Water : ad libitum, mains drinking water
- Acclimatisation: 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:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: immediately after patch removal, 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of the back of the rabbit
- Type of wrap if used: cotton gauze patch secured in position with a strip of surgical adhesive tape, the trunk of the rabbit was wrapped in an elasticated corset during exposure
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, any residual test item was removed by gentle swabbing with cotton wool saked in distilled water
- Time after start of exposure: 4h
SCORING SYSTEM: according to Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal: #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all three animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was noted at one treated skin site at the 24 and 48 h reading time points. Effects were fully reversible within 72 h.
- Other effects:
- All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Erythema score
Animal Number |
1 h |
1 day |
2 days |
3 days |
71416 |
0 |
0 |
0 |
0 |
71453 |
0 |
1 |
1 |
0 |
71454 |
0 |
0 |
0 |
0 |
Table 2: Edema score
Animal Number |
1 h |
1 day |
2 days |
3 days |
71416 |
0 |
0 |
0 |
0 |
71453 |
0 |
0 |
0 |
0 |
71454 |
0 |
0 |
0 |
0 |
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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