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EC number: 259-839-8 | CAS number: 55819-71-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-Sep-2014 to 09-Sep-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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines 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
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.47 “Bovine corneal opacity and permeability method for identifying ocular corrosives and severe irritants ".
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- DL-serinohydrazide monohydrochloride
- EC Number:
- 259-839-8
- EC Name:
- DL-serinohydrazide monohydrochloride
- Cas Number:
- 55819-71-1
- Molecular formula:
- C3H9N3O2.ClH
- IUPAC Name:
- 2-amino-3-hydroxy-propanehydrazide;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 hydrazide
- Substance type: white powder
- Physical state: powder
- Storage condition of test material: At room temperature in the dark under nitrogen
Constituent 1
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20% (w/w) solution (750 µl) per cornea
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
- Value:
- 4.6
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The corneas were slightly translucent after the 240 minutes of treatment with DL Serine hydrazide. 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:
- other: no prediction on the classification can be made
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Since DL Serine hydrazide induced an IVIS > 3 = 55, no prediction on the classification can be made.
- Executive summary:
The negative control responses of the opacity and permeability values 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 of the positive control (20% (w/v) Imidazole) was 128 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 hydrazide induced ocular irritation through only one endpoint (opacity), resulting in a meanin vitroirritancy score of 4.6 after 240 minutes of treatment.
Since DL Serine hydrazide induced an IVIS > 3=55, no prediction on the classification can be made.
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