Methyl DL-serinate hydrochloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05-May-2014 to 06-May-2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 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

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EC Guideline B.47 “Bovine corneal opacity and permeability method for identifying ocular corrosives and severe irritants ". Official Journal of the European Union No. L324; Amended by EC No. 1152/2010 No. L142

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Methyl DL-serinate hydrochloride

EC Number:

227-047-1

EC Name:

Methyl DL-serinate hydrochloride

Cas Number:

5619-04-5

Molecular formula:

C4H9NO3.ClH

IUPAC Name:

methyl 2-amino-3-hydroxypropanoate hydrochloride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): DL-serine Methylester HCl
- Substance type: White crystalline powder
- Physical state: Solid
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

Bovine eyes from young cattle were obtained from the slaughterhouse, where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.

Test system

Vehicle:

physiological saline

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 750 µl per cornea, 20% (w/w) solution

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 20% (w/v) Imidazole

Duration of treatment / exposure:

240 minutes

Details on study design:

TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 240 minutes

SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.

- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).


TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
In vitro score range UN GHS
= 3 No Category
> 3; = 55 No prediction can be made
>55 Category 1

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

74

Other effects / acceptance of results:

The corneas were turbid after the 240 minutes of treatment with DL-serine Methylester HCl. A pH effect of the test substance was observed on the rinsing medium, the corneas were rinsed until no colour change of the medium was observed.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DL-serine Methylester HCl is corrosive or severe irritant in the Bovine Corneal Opacity and Permeability test

Executive summary:

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.The mean in vitro irritancy score (IVIS) of the positive control (20% (w/v) Imidazole) was 165 and within the historical positive control data range.It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

 

DL-serine Methylester HCl induced severe ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 74 after 240 minutes of treatment.

 

Since DL-serine Methylester HClinduced an IVIS=55.1, it is concluded that DL-serine Methylester HCl is corrosive or severe irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.

 

Based on these results, the test substance should be classified as serious eye damage, category 1 according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations and H318 according to the Regulation on classification, labelling and packaging of substancesand mixtures (CLP).