Registration Dossier
Registration Dossier
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EC number: 211-734-8 | CAS number: 692-86-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Feb - 25 Jun 1997
- 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:
- adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- Age of animals not stated, flank region used
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl undec-10-enoate
- EC Number:
- 211-734-8
- EC Name:
- Ethyl undec-10-enoate
- Cas Number:
- 692-86-4
- Molecular formula:
- C13H24O2
- IUPAC Name:
- ethyl undec-10-enoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, Prouzel, France
- Weight at study initiation: 2.6 ±0.1 kg
- Housing: polystyrene cages (35x55x32 cm or 48.2x58x36.5 cm)
- Diet: ad libitum, pelleted commercially available diet, periodically checked (bacteriological and chemical analysis)
- Water: ad libitum, filtered water, periodically checked (bacteriological and chemical analysis)
- Acclimation period:at least 5 days prior to study start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±3
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26 Feb 1997 - 01 Mar 1997
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: flanks
A single dose of 0.5 ml of the test substance was prepared on a 6 cm2 dry gauze pad
(Cooperative Pharmaceutique Francaise, 77000 Melun, France) which was then applied to the
right flank of the animals for 4 hours.
The test substance and the gauze pad were held in contact with the skin by means of an adhesive
hypoallergenic aerated semi-occlusive dressing (Laboratoires de Pansements et d'Hygiene,
21300 Chenove, France) and a restraining bandage (Laboratoires 3M Sante, 92245 Malakoff.
France).
The day before treatment, the flanks of each animal were clipped using electric clippers. The
skin of each animal was examined in order to use only animals without any signs of cutaneous
irritation. Animals showing signs of cutaneous irritation, cutaneous defects or pre-existing
dermal injury were not used.
The untreated skin served as control.
REMOVAL OF TEST SUBSTANCE
No residual test substance was noted at removal of the dressing.
OBSERVATION TIME POINTS
1, 24, 48, and 72 hours after removal of dressing
SCORING SYSTEM: Draize
Erythema and eschar formation:
no erythema ... . . . . . . . . .. . . . . .. . .. . . .. . . . . . .. .. . . . . .. . . . .. . .. .. .. ... ... .. . 0
very slight erythema (barely perceptible) ........................................................... 1
well-defined erythema ....................................................................................... 2
moderate to severe erythema ................................... .......... ................................ 3
severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation
no oedema ......................................................................................................... 0
very slight oedema (barely perceptible) .............................................................. l
slight oedema (edges of area well-defined by definite raising) ......................... 2
moderate oedema (raised approximately 1 millimetre) ...................................... 3
severe oedema (raised more than 1 millimetre and extending beyond area of exposure) .......... 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean after
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean after
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean after
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean after
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- A very slight or well-defined erythema (grade 1 or 2) was observed at the 1-hour reading time point in all animals; a very slight erythema (grade 1) persisted for 24 hours in 1/3 animal and for 48 hours in 1/3 animals. A slight oedema (grade 2) was also observed on day 1 in 1/3 animals. Mean scores over 24, 48 and 72 hours for individual animal were 0.33, 0.67 and 0.0 for erythema and 0.0 for oedema.
Any other information on results incl. tables
Erythema |
|
|
|
Time after end of 4h exposure |
24h |
48h |
72h |
Rabbit 1 |
1 |
0 |
0 |
Rabbit 2 |
1 |
1 |
0 |
Rabbit 3 |
0 |
0 |
0 |
Edema |
|
|
|
Time after end of 4h exposure |
24h |
48h |
72h |
Rabbit 1 |
0 |
0 |
0 |
Rabbit 2 |
0 |
0 |
0 |
Rabbit 3 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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