Registration Dossier
Registration Dossier
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EC number: 271-694-2 | CAS number: 68604-44-4 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated tetralkyl carboxylic acid pentaerythritol tetraester and SDA Reporting Number: 11-016-00.
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
- 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:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, esters with pentaerythritol
- EC Number:
- 285-547-5
- EC Name:
- Fatty acids, C16-18, esters with pentaerythritol
- Cas Number:
- 85116-93-4
- IUPAC Name:
- 85116-93-4
- Details on test material:
- - Name of test material (as cited in study report): fatty acids, C16-18, esters with pentaerythritol
- Physical state: white, solid
- Analytical purity: 99%
- Lot/batch No.: 51531022
- Stability under test conditions: 18 months
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation: 19-20 months
- Weight at study initiation: approx. 2.7 kg
- Housing: single holding in cage
- Diet: ad libitum (Altromin Haltungsdiät 2023)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansing with clean warm water
- Time after start of exposure: 4 h (upon removal of the dressing)
SCORING SYSTEM: The application sites were assessed for signs of erythema and oedema and scored according to the 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: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
Any other information on results incl. tables
Erythema score
Animal Number |
1 day |
2 days |
3 days |
Mean Score |
1226 |
0 |
0 |
0 |
0 |
1230 |
0 |
0 |
0 |
0 |
1231 |
0 |
0 |
0 |
0 |
Edema Score
Animal Number |
1 day |
2 days |
3 days |
Mean Score |
1226 |
0 |
0 |
0 |
0 |
1230 |
0 |
0 |
0 |
0 |
1231 |
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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