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EC number: 203-891-6 | CAS number: 111-64-8
Toxicological information
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:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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:
- Octanoyl chloride
- EC Number:
- 203-891-6
- EC Name:
- Octanoyl chloride
- Cas Number:
- 111-64-8
- Molecular formula:
- C8H15ClO
- IUPAC Name:
- octanoyl chloride
- Details on test material:
- - Name of test material (as cited in study report): n-Octansaeurechlorid
- Physical state: Colorless liquid
- Analytical purity: 97% (by GC)
- Lot/batch No.: Vers. 62/V
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. THOMAE GMBH, BIBERACH, D
- Age at study initiation: young adult
- Weight at study initiation: 3.38 - 4.00 kg
- Housing: SINGLE HOUSING IN STAINLESS STEEL WIRE MESH CAGES WITH GRATING, FLOOR AREA: 3000 CM2
- Diet: KLIBA-LABORDIAET, KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND; ABOUT 130 G PER ANIMAL PER DAY
- Water: ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Acclimation period: ACCLIMATIZATION FOR AT LEAST 1 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: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 3 MIN, 1 H, 4 H
- Observation period:
- 15 d
- Number of animals:
- 3 per treatment
- Details on study design:
- TEST SITE
- Area of exposure: UPPER THIRD OF THE BACK 01R FLANKS
- Type of wrap if used: THE TEST SUBSTANCE HAS BEEN COVERED WITH A TEST PATCH (IDEALBINDE, PFAELZISCHE VERBANDSTOFF-FABRIK, KAISERSLAUTERN) AND FIXOMULL(R) STRETCH (ADHESIVE FLEECE), BEIERSDORF AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): THE TEST SUBSTANCE WAS REMOVED AT THE END OF THE EXPOSURE PERIOD) WITH LUTROL(R) AND LUTROL(R)/WATER ( 1:1)
SCORING SYSTEM: OECD scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 min exposure
- Time point:
- other: 24 - 48- 72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Remarks on result:
- other: Severe scaling observed at the final reading; see table for details
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 min exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.78
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 h exposure
- Time point:
- other: 24 - 48- 72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Remarks on result:
- other: Severe scaling observed; see table for details
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1 h exposure
- Time point:
- other: 24 - 48- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 4 h exposure
- Time point:
- other: 24 - 48- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Remarks on result:
- other: 1/3 animal was sacrificed because of severe irritation; a necrosis of this animal was histo-pathologically determined as superficial; see table for details
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 4 h exposure
- Time point:
- other: 24 - 48- 72 h
- Score:
- 3.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
Any other information on results incl. tables
| Exposition: | 3 min | |||
| Animal | Reading | Erythema | Edema | Symptoms |
| 1 | 1 h | 2 | 3 | |
| 2 | 1 h | 2 | 2 | Erythema extending beyond the area of exposure |
| 3 | 1 h | 2 | 2 | Erythema extending beyond the area of exposure |
| 1 | 24 h | 3 | 1 | Erythema and edema extending beyond the area of exposure |
| 2 | 24 h | 3 | 1 | Erythema and edema extending beyond the area of exposure |
| 3 | 24 h | 2 | 1 | Erythema and edema extending beyond the area of exposure |
| 1 | 48 h | 3 | 1 | Erythema and edema extending beyond the area of exposure |
| 2 | 48 h | 3 | 1 | Erythema and edema extending beyond the area of exposure |
| 3 | 48 h | 2 | 0 | Erythema extending beyond the area of exposure |
| 1 | 72 h | 3 | 1 | Erythema and edema extending beyond the area of exposure |
| 2 | 72 h | 3 | 1 | Erythema and edema extending beyond the area of exposure |
| 3 | 72 h | 2 | 0 | Erythema extending beyond the area of exposure |
| 1 | 8 d | 2 | 0 | Erythema extending beyond the area of exposure; Severe scaling extending beyond the area of exposure |
| 2 | 8 d | 2 | 0 | Scaling; Erythema extending beyond the area of exposure |
| 3 | 8 d | 1 | 0 | Erythema extending beyond the area of exposure; Severe scaling extending beyond the area of exposure |
| 1 | 15 d | 0 | 0 | Severe scaling extending beyond the area of exposure |
| 2 | 15 d | 2 | 1 | Severe scaling |
| 3 | 15 d | 1 | 0 | Severe scaling |
| mean animal 1 | 24 - 72 h | 3.00 | 1.00 | |
| mean animal 2 | 24 - 72 h | 3.00 | 1.00 | |
| mean animal 3 | 24 - 72 h | 2.00 | 0.33 | |
| mean | 24 - 72 h | 2.67 | 0.78 | |
| Exposition: | 1 h | |||
| Animal | Reading | Erythema | Edema | Symptoms |
| 1 | 1 h | 2 | 4 | Hemorrhage; Erythema and edema extending beyond the area of exposure |
| 2 | 1 h | 3 | 2 | Hemorrhage; Erythema and edema extending beyond the area of exposure |
| 3 | 1 h | 3 | 3 | Hemorrhage; Erythema and edema extending beyond the area of exposure |
| 1 | 24 h | 3 | 4 | Erythema and edema extending beyond the area of exposure |
| 2 | 24 h | 3 | 2 | Erythema and edema extending beyond the area of exposure |
| 3 | 24 h | 4 | 3 | Erythema and edema extending beyond the area of exposure |
| 1 | 48 h | 3 | 4 | Erythema and edema extending beyond the area of exposure |
| 2 | 48 h | 4 | 2 | Erythema and edema extending beyond the area of exposure |
| 3 | 48 h | 4 | 3 | Superficial scabbing; Erythema and edema extending beyond the area of exposure |
| 1 | 72 h | 4 | 3 | Erythema and edema extending beyond the area of exposure |
| 2 | 72 h | 4 | 3 | Superficial scabbing; Erythema and edema extending beyond the area of exposure |
| 3 | 72 h | 4 | 3 | Erythema extending beyond the area of exposure |
| 1 | 8 d | 4 | 1 | Superficial scabbing; Erythema and edema extending beyond the area of exposure |
| 2 | 8 d | 4 | 2 | Severe scaling; Erythema and edema extending beyond the area of exposure; Severe scaling extending beyond the area of exposure |
| 3 | 8 d | 4 | 1 | Erythema and edema extending beyond the area of exposure; Severe scaling extending beyond the area of exposure |
| 1 | 15 d | 2 | 1 | Erythema and edema extending beyond the area of exposure |
| 2 | 15 d | 3 | 2 | Erythema and edema extending beyond the area of exposure |
| 3 | 15 d | 3 | 2 | Scaling; Erythema and edema extending beyond the area of exposure |
| mean animal 1 | 24 - 72 h | 3.33 | 3.67 | |
| mean animal 2 | 24 - 72 h | 3.67 | 2.33 | |
| mean animal 3 | 24 - 72 h | 4.00 | 3.00 | |
| mean | 24 - 72 h | 3.67 | 3.00 | |
| Exposition: | 4 h | |||
| Animal | Reading | Erythema | Edema | Symptoms |
| 4 | 1 h | 3 | 3 | Erythema and edema extending beyond the area of exposure |
| 5 | 1 h | 2 | 3 | Erythema and edema extending beyond the area of exposure |
| 6 | 1 h | 2 | 3 | Erythema and edema extending beyond the area of exposure |
| 4 | 24 h | 4 | 3 | Erythema and edema extending beyond the area of exposure |
| 5 | 24 h | 4 | 3 | Necrosis; Erythema and edema extending beyond the area of exposure |
| 6 | 24 h | 4 | 3 | Erythema and edema extending beyond the area of exposure |
| 4 | 48 h | 4 | 4 | Erythema and edema extending beyond the area of exposure |
| 5 | 48 h | 4 | 3 | Necrosis; Erythema and edema extending beyond the area of exposure |
| 6 | 48 h | 4 | 3 | Superficial scabbing; Erythema and edema extending beyond the area of exposure |
| 4 | 72 h | 4 | 4 | Erythema and edema extending beyond the area of exposure |
| 5 | 72 h | 4 | 3 | Necrosis; Gross-Examination of the skin; Study discontinued because of severe irritation; Erythema and edema extending beyond the area of exposure |
| 6 | 72 h | 4 | 3 | Superficial scabbing; Erythema and edema extending beyond the area of exposure |
| 4 | 8 d | 4 | 2 | Erythema and edema extending beyond the area of exposure; Superficial scabbing extending beyond the area of exposure |
| 6 | 8 d | 4 | 1 | Superficial scabbing; Erythema and edema extending beyond the area of exposure |
| 4 | 15 d | 2 | 2 | Severe scaling; Erythema and edema extending beyond the area of exposure |
| 6 | 15 d | 2 | 1 | Erythema and edema extending beyond the area of exposure; Scaling extending beyond the area of exposure |
| mean animal 4 | 24 - 72 h | 4.00 | 3.67 | |
| mean animal 5 | 24 - 72 h | 4.00 | 3.00 | |
| mean animal 6 | 24 - 72 h | 4.00 | 3.00 | |
| mean | 24 - 72 h | 4.00 | 3.22 |
Additional examinations: The treated skin of animal #5 (4 h exposure) showed red-yellow discolouration with hard surface after pathological-anatomical evaluation. A histo-pathological examination defined this treated area as superficial necrosis (necrosis of the epidermis).
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
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