Registration Dossier
Registration Dossier
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EC number: 427-370-1 | CAS number: 164288-56-6
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: OECD guideline, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1997
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:
- -
- EC Number:
- 427-370-1
- EC Name:
- -
- Cas Number:
- 164288-56-6
- Molecular formula:
- C21H44N3O3Cl
- IUPAC Name:
- {[(2-hydroxyethyl)carbamoyl]methyl}dimethyl(3-octadecanamidopropyl)azanium chloride
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
Constituent 1
impurity 1
impurity 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species, strain, supplier : New-zealand albino rabbit, elevage CharLes RIVER (76410 Saint-Aubin-Les-Elbeuf, France).
Reason for species selection : the New-zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatory authorities.
- Number and sex: 3 males
If strong effects are foreseeable, the test is performed in one animaI. From the results obtained, the test may be not realized in the two others.
- Average weight : 2.6 kg
- Identification: auricular ring
- Acclimatization: at least 5 days
- Housing, diet : environmentai conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individual housing on floor grid). Complete pelleted rabbit maintenance diet Energie H326, COFNA (37000 - TOURS, FRANCE).
Test system
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- - Preparation: approximately 24 hours before the test, fur is removed by clipping from the dorsal area of the trunk of the animais. Care is taken to avoid abrading the skin. Only animals with healthy intact skin are used.
The test material is applied under a semi-occlusive patch to the skin of the 3 rabbits at the dose of 0.5 mL/rabbit according to the following procedure:
- 0.5 mL of the test material are applied to the clipped skin, then covered with a gauze (2.5 x 2.5 cm) held in place by means of a 5 x 5 cm wide “Micropore” fastening tape. Then the animal’s trunk is wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width, place in such a way so as not to hinder respiratory movements.
- the rabbits are returned to their cages for 4 hours at the end of which the dressing and the gauze patch are removed. Then, residual test substance is removed, using absorbent paper moistened with distilled water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 1
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 hr
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible
Any other information on results incl. tables
Under the experimental conditions adopted, the application of the test item for 4 hours to the skin of the rabbit produces in all animaIs, at the one hour’s reading, the outbreak of well defined erythemae with a very slight oedema in one of them. 24 hours afler patch removal, only very slight erythemae are still visible in the three rabbits. The reversibility is complete in less than 48 hours in one animal and in less than 72 hours in the two others.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the 67/548/EEC order classification, the test item (containing 35-40% of the notified chemical) is non irritant to skin.
- Executive summary:
The aim of this study was to assess the irritation potential to skin of the test item. The protocole was designed according to the OECD 404 guideline for the test item (i.e. 35-40% of the notified chemical).
3 new-zealand albino rabbits were used for this study. 0.1 mL was applied under semi occlusive conditions to the skin of the animals.
4 hours later, thee patch was removed and the skin was rinced.
Under the experimental conditions adopted, the application of the test item for 4 hours to the skin of the rabbit produces in all animals, at the one hour’s reading, the outbreak of well defined erythemae with a very slight oedema in one of them. 24 hours afler patch removal, only very slight erythemae are still visible in the three rabbits. The reversibility is complete in less than 48 hours in one animal and in less than 72 hours in the two others.
According to the 67/548/EEC order classification, the test item (containing 35-40 % of notified chemical ) is non irritant to skin.
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