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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:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to GLP and valid methods and is considered relevant and reliable for classification. It is an in vitro study predicting eye irritation, which is considered adequate in combination with the in vitro testing for serious eye damage.

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, published 2010.
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts
EC Number:
939-704-6
Cas Number:
867040-07-1
Molecular formula:
Molecular formula cannot be given as the substance is a mixture
IUPAC Name:
Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts
Test material form:
other: liquid

Test animals / tissue source

Species:
other: fertile chicken eggs
Strain:
other: White legghorn
Details on test animals or tissues and environmental conditions:
Not applicable

Test system

Vehicle:
physiological saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 µL/egg (used undiluted)

Duration of treatment / exposure:
20 seconds
Observation period (in vivo):
5 minutes

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: irritation index
Remarks:
mean
Run / experiment:
test group
Value:
10
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: maximum score = 21
Irritation parameter:
other: irritation index
Remarks:
mean
Run / experiment:
0.1% NaOP positive control group
Value:
18.3
Remarks on result:
other: maximum score = 21
Irritation parameter:
other: irritation index
Remarks:
mean
Run / experiment:
1% SDS positive control group
Value:
10
Remarks on result:
other: maximum score = 21
Irritation parameter:
other: irritation index
Remarks:
mean
Run / experiment:
0.9% NaCl negative control group
Value:
0
Remarks on result:
other: maximum score = 21

Any other information on results incl. tables

The purpose of this study was to determine the eye irritancy potential of Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18­unsaturated alkyl) tetrasodium salts by means of the chorioallantoic membrane of hens' eggs (HET-CAM). Eye irritation caused by external contact with chemical substances is characterized by corneal damage and/or conjunctival injury and/or iris defects.

The CAM of fertile eggs incubated for 9 days is a vital vascular membrane with a blood vessel complex.

Three eggs each were treated with 300 µL Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts/egg and with the control items. 0.9% NaCl solution was used as the negative control item. 0.1 N Sodium hydroxide (NaOH) and 1% aqueous sodium dodecyl sulphate (SDS) were used as the positive control items. The administration volume for the control items was 300 µL 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 Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts revealed aneffect with an irritation index (IS) of 10.0. The test item was considered to be a strong irritant.

The positive control items 0.1% NaOH or 1% SDS caused the expected effect with irritation indices (IS) of 18.3 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.

Applicant's summary and conclusion

Interpretation of results:
other: predicted irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the present test conditions, Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts was a strong irritant to eyes in an experiment employing the chorioallantoic membrane of hens' eggs (HET-CAM) as model.
Executive summary:

The purpose of this study was to determine the eye irritancy potential of Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18­unsaturated alkyl) tetrasodium salts by means of the chorioallantoic membrane of hens' eggs (HET-CAM). Eye irritation caused by external contact with chemical substances is characterized by corneal damage and/or conjunctival injury and/or iris defects.

The CAM of fertile eggs incubated for 9 days is a vital vascular membrane with a blood vessel complex.

Three eggs each were treated with 300 µL Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts/egg and with the control items. 0.9% NaCl solution was used as the negative control item. 0.1 N Sodium hydroxide (NaOH) and 1% aqueous sodium dodecyl sulphate (SDS)were used as the positive control items. The administration volume for the control items was 300 µL 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 Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts revealed an effect with an irritation index (IS) of 10.0. The test item was considered to be a strong irritant.

The positive control items 0.1or 1% SDS caused the expected effect with irritation indices (IS) of 18.3 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.