Registration Dossier
Registration Dossier
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EC number: 289-450-9 | CAS number: 88895-93-6
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive application
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Institut für Toxikologie, Henkel KGaA, Düsseldorf, Germany
Test material
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd.
- EC Number:
- 266-932-7
- EC Name:
- Fatty acids, C16-18 and C18-unsatd.
- Cas Number:
- 67701-08-0
- IUPAC Name:
- 67701-08-0
- Details on test material:
- - Name of test material (as cited in study report): Edenor Ti Dest (FS010)
- Physical state: white, solid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: mean 2445 g
- Housing: individually in rabbit cages (Fa. Heinkel, Kuchen, Germany)
- Diet (e.g. ad libitum): Zucht-/Haltungsdiät 20 ZH 5 (Fa. Nohrlin GmbH, Bad Salzuflen, Germany)
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: minumum 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): ca. 45 - 50
- Photoperiod (hrs dark / hrs light): 1 2 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 15 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: back of animals
- Site preparation: shaved 24 hours prior to application
- Type of wrap if used: 2.5x2.5cm cotton linen patch covered by a cling film and secured by adhesive tape and plastic band
SCORING SYSTEM:
Erythema:
0 - no erythema
1 - very slight erythema (barely perceptible)
2 - well-defined erythema
3 - moderate to severe erythema
4 - severe erythema (beet redness) to slight eschar formation (injuries in deep)
Edema:
0 - no edema
1- very slight edema (barely perceptible)
2 - slight edema (edges of area well defined by definite rising)
3 - moderate edema (raised appr. 1 mm)
4 - severe edema (raised >1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- other: mean 24 - 48 - 72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- other: mean 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Readings:
| Time | Animal | Erythema | Edema | Additional findings |
| 1 h | 1 | 1 | 2 | |
| 2 | 1 | 2 | ||
| 3 | 1 | 1 | ||
| 4 | 2 | 1 | ||
| 24 h | 1 | 3 | 1 | |
| 2 | 2 | 1 | ||
| 3 | 2 | 1 | ||
| 4 | 3 | 1 | ||
| 48 h | 1 | 2 | 1 | |
| 2 | 1 | 1 | ||
| 3 | 1 | 1 | ||
| 4 | 2 | 1 | ||
| 72 h | 1 | 2 | 1 | |
| 2 | 1 | 1 | ||
| 3 | 1 | 1 | ||
| 4 | 2 | 1 | ||
| 7 days | 1 | 0 | 0 | s |
| 2 | 0 | 0 | s | |
| 3 | 0 | 0 | ||
| 4 | 1 | 0 | s | |
| 10 days | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 0 | 0 | s | |
| 15 days | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 0 | 0 | ||
| mean 24 - 48 - 72 h | 1 | 2.3 | 1.0 | |
| 2 | 1.3 | 1.0 | ||
| 3 | 1.3 | 1.0 | ||
| 4 | 2.3 | 1.0 | ||
| mean | 1.8 | 1.0 | ||
s: scaling
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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