Registration Dossier
Registration Dossier
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EC number: 253-462-2 | CAS number: 37321-62-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Nov 1998 - 29 Jan 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- no rationale for in vivo testing
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992 - 1993
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dodecanoic acid, ester with 1,2-propanediol
- EC Number:
- 253-462-2
- EC Name:
- Dodecanoic acid, ester with 1,2-propanediol
- Cas Number:
- 37321-62-3
- Molecular formula:
- C15H30O3 C27H52O4
- IUPAC Name:
- Dodecanoic acid, ester with 1,2-propanediol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- NZW I.N.R.A. A9077 (known bacteriological and viral status)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: E.S.D. (Romans, 01400 Chatillon-sur-Chalaronne, France)
- Age at study initiation: about 3 months old
- Weight at study initiation: 2.3 - 2.54 kg
- Gender: male
- Housing: individually in stainless steel cages (50x60x40 cm)
- Diet (e.g. ad libitum): Pelleted complete rabbit diet, about 150 g/animal/day
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 (+/-3)
- Humidity (%): 23.4 to >45
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 24 Nov 1998 - 01 Dec 1998
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- at least the day before application back and flanks of rabbits were carefully clipped. Only animals with intact skin were included.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per animal
- Concentration (if solution): pure, considered 100% for this study
NEGATIVE CONTROL: none
POSITIVE CONTROL: none - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days, up to full recovery
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: Codex hydrophilic eight layer gauze pad (approx 2.5 cm x 2.5 cm) maintained in contact with the skin with a perforated tape. The tape was applied on a crimped gaze bandage to fully cover the clipped area, wrapped around the animal.
REMOVAL OF TEST SUBSTANCE
Excess test article was wiped away with a gauze pad moistened with water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Morbidity: twice daily
Body weighing: on the day of dosing
Time of cutaneus readings: 1, 24, 48, 72 h, and 7days after removal of bandage.
SCORING SYSTEM:
- Method of calculation: Erythema (max. 4) and Edema (max. 4) scores as published in OECD guideline 404 (1992).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: #3, #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility not applicable
- Other effects:
- No mortality during the study.
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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