N,N-dimethyldecylamine N-oxide

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:

2012

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

Test material information

Constituent 1

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

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.