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EC number: 220-020-5 | CAS number: 2605-79-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 November - 28 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM-Recommended Test Method Protocol: Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Test Method (2010)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N-dimethyldecylamine N-oxide
- EC Number:
- 220-020-5
- EC Name:
- N,N-dimethyldecylamine N-oxide
- Cas Number:
- 2605-79-0
- Molecular formula:
- C12H27NO
- IUPAC Name:
- decyl(dimethyl)amine oxide
- Test material form:
- other: aqueous solution
- Details on test material:
- - Name of test material (as cited in study report): N,N-dimethyldecylamine-N-oxide (solution)
- Substance type: colourless to yellowish liquid
- Analytical purity: 40.5% active (aqueous solution)
- Impurities (identity and concentrations): peroxide: 0.01%, free amine: < 0.5%
- Purity test date: 2011-11-14
- Lot/batch No.: 1108042301
- Expiration date of the lot/batch:2 years in original closed packaging
- Storage condition of test material: 10 - 25°C
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: White Leghorn
- Details on test animals or tissues and environmental conditions:
- Fertile white Leghorn chicken eggs
Weight: 48 – 52 g
Age: ≤7 days
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 mL/egg
- Concentration (if solution): 40.5% (aqueous solution used without further dilution) - Duration of treatment / exposure:
- 20 seconds
- Observation period (in vivo):
- 5 minutes
- Number of animals or in vitro replicates:
- 3 eggs/group
- Details on study design:
- Test item: 3 eggs treated with the test item
Negative control item: 3 eggs treated with physiological saline
Positive control items:3 eggs treated with NaOH (0.1 N); 3 eggs treated with SDS (1%)
Application: on the chorioallantoic membrane of fertilized hens' eggs
SCORING SYSTEM: see tables below
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of 3 tests
- Value:
- 16.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: range 15-17
Any other information on results incl. tables
Table 1: HET-CAM Mean Irritation Scores (IS)
|
Effect according to scoring scheme for irritation testing |
|||
Haemorrhage |
Lysis |
Coagulation |
Irritation Score (IS) |
|
C10 AO
Mean SD |
7 |
3 |
7 |
17 |
7 |
3 |
7 |
17 |
|
7 |
3 |
5 |
15 |
|
7.0 0.0 |
3.0 0.0 |
6.3 1.2 |
16.3 1.2 |
|
Negative control (0.9% NaCl soln)
Mean SD |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
0.0 0.0 |
0.0 0.0 |
0.0 0.0 |
0.0 0.0 |
|
Positive control (0.1 N NaOH)
Mean SD |
7 |
3 |
9 |
19 |
7 |
3 |
7 |
17 |
|
7 |
3 |
7 |
17 |
|
7.0 0.0 |
3.0 0.0 |
7.7 1.2 |
17.7 1.2 |
|
Positive control (1% SDS)
Mean SD |
7 |
3 |
0 |
10 |
7 |
3 |
0 |
10 |
|
7 |
3 |
0 |
10 |
|
7.0 0.0 |
3.0 0.0 |
7.0 0.0 |
10.0 0.0 |
|
SD: standard deviation
1% SDS: 1% aqueous sodium dodecyl sulfate
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results of this test, C10 AO is considered to be strongly irritating to eyes
- Executive summary:
Three eggs each were treated with 0.3 mL C10 AO solution/egg and with the control items. 0.9% NaCl solution was used as the negative control item. 0.1 N Sodium hydroxide (NaOH) or 1% aqueous sodium dodecyl sulphate (SDS) were used as the positive control items. The administration volume for the control items was 0.3 mL per egg. After administration of the test item blood vessels including the capillary system and the albumen were examined and scored for irritant effects (haemorrhage, coagulation and lysis) during 5 minutes. The eggs treated with C10 AO solution revealed an effect with an irritation score (IS) of 16.3. The test item was considered to be a strong irritant.
The positive control items 0.1 N NaOH or 1% SDS caused the expected effect with irritation scores (IS) of 17.7 or 10.0, respectively and, hence, were well within the historical data-range.No effects were observed in the negative control 0.9% NaCl solution.Hence,the HET-CAM assay is considered to be valid.
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