Registration Dossier
Registration Dossier
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EC number: 211-330-1 | CAS number: 638-29-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- current version: 28 Jul 2015, originally adopted in 1981, revised in 1992 and 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Valeryl chloride
- EC Number:
- 211-330-1
- EC Name:
- Valeryl chloride
- Cas Number:
- 638-29-9
- Molecular formula:
- C5H9ClO
- IUPAC Name:
- pentanoyl chloride
- Details on test material:
- - Physical state / appearance: liquid / colourless, clear
- Substance number: 96/184
- Batch number: Vers. 130/U
- Analytical purity: 99.4%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Supplier: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult female
- Weight at study initiation: 4.00 kg
- Housing: stainless steel wire mesh cages with grating, floor area 3000 cm2; single housing; no bedding in the cages, sawdust in the waste trays
- Diet: ca. 130 g KLIBA-labordiaet 341 (Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland) per animal per day
- Water: 250 ml tap water per animal per day
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: the fur was removed by clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied): 0.5 ml - Duration of treatment / exposure:
- 3 min and 1 h
- Observation period:
- 1 and 24 h
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: idealbinde, Pfälzische Verbandtstoff-Fabrik, Kaiserslautern) and Fixomull® strech (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol® E 400 (Polyethylene glycol DAB, BASF AG) and Lutrol®:water (1:1)
- Time after start of exposure: 3 min and 1 h
SCORING SYSTEM: acccording to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: The average score (24 to 72 hours) for irritation could not be calculated because of visual necrosis and therefrom resulting study termination 24 hours after removal of the patch.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: The average score (24 to 72 hours) for irritation could not be calculated because of visual necrosis and therefrom resulting study termination 24 hours after removal of the patch.
- Irritant / corrosive response data:
- Full thickness necrosis (confirmed by cross-incision of the treated skin and histopathological examination) was observed at all exposure durations and erythema and edema were observed beyond the area of exposure. The study was discontinued because of severe skin irritation.
The cross incision of the treated skin has been performed after the animal was killed at study termination.
Any other information on results incl. tables
Erythema and edema scores
| Exposure | Animal | Readings | Erythema | Edema | Symptoms |
| 3 min | #1 | 1 h | - | 2 | N, 07, 16 |
| 3 min | #1 | 24 h | - | 2 | N, PA, SI, 08, 16 |
| 1 h | #1 | 1 h | - | 2 | N, 07, 16 |
| 1 h | #1 | 24 h | - | 3 | N, PA, SI, 08, 16 |
-: Findings which could not be read (for reasons see symptoms)
N: Necrosis
PA: Gross-examination of the skin
SI: study discontinued because of severe irritation
07: Index for erythema of the surrounding area: 2
08: Index for erythema of the surrounding area: 3
16: Edema extending beyond the area of exposure
Histopathological examination:
Exposure period: 3 min and 1 hour
Full thickness necrosis
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
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