(carboxylatomethyl)dodecyldimethylammonium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(carboxylatomethyl)dodecyldimethylammonium

EC Number:

211-669-5

EC Name:

(carboxylatomethyl)dodecyldimethylammonium

Cas Number:

683-10-3

Molecular formula:

C16H33NO2

IUPAC Name:

(carboxylatomethyl)dodecyldimethylammonium

Test material form:

solid

Details on test material:

Chemical Name Lauryl betaine
Physical State liquid - The sample was dried under a nitrogen purge to remove water prior to analysis.
CAS # 683-10-3
EU # 211-669-5
Manufacturer Colonial Chemical
Batch/lot # 53715J16
Received on November 22, 2016
Tested on January 31, 2017

Specific details on test material used for the study:

ColaTeric LAB-70UP product was supplied by Colonial for this test.
The lot # was 55880C17.
This product contains lauryl betaine at 35% active strength in water.

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

The ColaTeric product was applied at 10% in saline. This infers that the strength of the active that was applied was 3.5%
A volume of 0.75ml was applied uniformly to the bovine cornea under conditions specified in the method.

Duration of treatment / exposure:

10 minutes, followed by a minimum of three washes.

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

Three corneas were used per article.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Remarks:

Mean score for three readings

Value:

30.7

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

Mean in-vitro score = 46.0

Results 2

Irritation parameter:

cornea opacity score

Remarks:

Mean score for three results

Value:

12

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

Mean opacity score = 27.3

Other effects / acceptance of results:

Acceptance criteria was met as being within 2 standard deviations of the current historical mean at the testing facility.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the conditions of the test, the sample eliicited an average in vitro score of 30.7.
The positive control elicited an average in vitro score of 46.0.
Under the decision cirteria of this test, these values fall within the 'No prdictions can be made' category.
However, since the test sample was only 35% active and the value obtained suggested some effect, albeit not Cat 1 H318, it is likely that the undiluted substance may well have been eye corrosive and thus a precuationary classification of H319 Eye irritant Cat 2 has been applied.