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Toxicological information

Skin irritation / corrosion

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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:
1997
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

Constituent 1
Chemical structure
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%

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


 













































ExposureAnimalReadingsErythemaEdemaSymptoms
3 min #11 h-2N, 07, 16
3 min #124 h-2N, PA, SI, 08, 16
1 h#11 h-2N, 07, 16
1 h#124 h-3N, 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