Registration Dossier
Registration Dossier
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EC number: 948-061-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October to 07 November, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline 404 with deviations: age at study initiation, individual animal weights, environmental conditions, purity of test item not reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age at study initiation, individual animal weights, environmental conditions, purity of test item not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides
- EC Number:
- 948-061-0
- Molecular formula:
- C18 H40 NO+ Cl- ; C20 H44 NO+ Cl- ; C22 H46 NO+ Cl- ; C22 H46 NO+ Cl- ; C22 H48 NO+ Cl-
- IUPAC Name:
- Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: Chimex / Batch M 303- Physical state: Yellowish limpid liquid- Date received: October 9, 1995- Purity test date: July 27, 1995STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: Stored at room temperature, away from the light and heat
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: elevage BERTHO, 22120 Yffiniac, France- Weight at study initiation: 2.3 kg (average weight)- Housing: Animals were housed individually on floor grids.- Diet: Complete pelleted rabbit maintenance diet Energie H326 (COFNA, 37000 - Tours, France), ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS: Environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline.IN-LIFE DATES: 23 October to 07 November, 1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL - Amount(s) applied (volume or weight with unit): 0.5 mL - Concentration (if solution): Undiluted
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h after patch removal and then on Days 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15.
- Number of animals:
- 3 males
- Details on study design:
- PREPARATION OF TEST SITEApproximately 24 h before the test, fur was removed by clipping from the dorsal area of the trunk of the animals. Only animals with healthy intact skin were used.TEST SITE- Area of exposure: Dorsal area of the trunk- Type of wrap if used: Test material was applied to the clipped skin and covered with a gauze (2 x 2 cm) held in place by means of a 5 x 5 cm wide "Micropore" fastening tape. Then the animal's trunk was wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width and placed in such a way so as not to hinder respiratory movements. Then the rabbits were returned to their cages for 4 h at the end of which the dressing and the gauze patch were removed. REMOVAL OF TEST SUBSTANCE - Washing (if done): Residual test material was removed using absorbent paper moistened with water. - Time after start of exposure: 4 hOBSERVATION TIME POINTS- 1, 24, 48 and 72 h after patch removal and then on Days 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15. SCORING SYSTEM: - Draize scale, as described in OECD Guideline 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Test substance applied as such for 4 h to the skin of the rabbit produces in the 3 animals the outbreak of moderate to important erythema and oedema. These signs of irritation, while decreasing from Day 6, persist until Day 10 in one animal and at the end of the observation period (Day 15) in the two others. Scabs were noticed on Day 7 in two rabbits; they disappeared in about five days and gave way to cicatrices.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test
Score at time point | Erythema (Animal no 1 / 2 / 3) Max. score 4 | Oedema (Animal no 1 / 2 / 3) Max. score 4 |
1 h | 2 / 2 / 2 | 2 / 2 / 1 |
24 h | 3 / 2 / 3 | 2 / 2 / 2 |
48 h | 3 / 3 / 3 | 2 / 2 / 2 |
72 h | 3 / 3 / 3 | 2 / 2 / 2 |
Day 5 | 3 / 3 / 3 | 2 / 2 / 2 |
Day 6 | 2 / 3 / 2 | 1 / 2/ 1 |
Day 7 | 2 / 2 / 2 | 1 / 2/ 1 |
Day 8 | 2 / 2 / 2 | 1 / 1 / 1 |
Day 9 | 2 / 2 / 2 | 1 / 1 / 1 |
Day 10 | 1 / 1 / 1 | 1 / 1 / 1 |
Day 11 | 1 / 0 / 1 | 1 / 0 / 1 |
Day 12 | 1 / - / 2 | 1 / - / 1 |
Day 13 | 1 / - / 2 | 1 / - / 1 |
Day 14 | 1 / - / 2 | 1 / - / 1 |
Day 15 | 1 / - / 2 | 0 / - / 1 |
Mean 24, 48 and 72 h | 3.0 / 2.7 / 3.0 | 2.0 / 2.0 / 2.0 |
- : No reading
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Under the test conditions, test substance is classified as "Category 1C: corrosive" to the skin according to Regulation (EC) No. 1272/2008 (CLP) and GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of the test substance was applied on the clipped skin of three male New Zealand White rabbits. The test substance was held in contact with the skin by means of a semi-occlusive dressing for 4 h. Skin reactions were assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after removal of the dressing and on Days 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15.
Test substance applied as such for 4 h to the skin of the rabbit produces in the 3 animals the outbreak of moderate to important erythema and oedema. These signs of irritation, while decreasing from Day 6, persist until Day 10 in one animal and at the end of the observation period (Day 15) in the two others. Scabs were noticed on Day 7 in two rabbits; they disappeared in about five days and gave way to cicatrices.
The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 3.0 / 2.7 / 3.0 for erythema and 2.0 / 2.0 / 2.0 for oedema.
Under the test conditions, test substance is classified as "Category 1C: corrosive" to the skin according to Regulation (EC) No. 1272/2008 (CLP) and GHS.
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