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Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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.

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