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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-01-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Limited documentation in report summary but study conducted in a consistent manner with SPL Standard Test method 569.05

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
other: SPL Standard Test Method 569.05
Qualifier:
no guideline followed
Principles of method if other than guideline:
Five enucleated eyes, obtained from the New Zealand White strain of rabbit were maintained at a termperature of 32 deg C +/- 1.5 deg C within a superfusion apparatus. 0.1 mL of the test material was applied onto the cornea of each of three enucleated eyes using the REET method. The direct effect of the test material was assessment by evaluating corneal thickness, corneal opacity, alteration of corneal epithelium, and fluorescein uptake after 60, 120, 180, and 140 minutes post dosing. These were rated using an attached scoring system.
GLP compliance:
not specified
Remarks:
The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report had not been audited by the QA Unit. No formal claim of GLP compliance was made for the study.

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl N-benzyl-N-(3-methoxy-3-oxopropyl)-β-alaninate
EC Number:
212-343-5
EC Name:
Methyl N-benzyl-N-(3-methoxy-3-oxopropyl)-β-alaninate
Cas Number:
793-19-1
Molecular formula:
C15H21NO4
IUPAC Name:
methyl 3-[benzyl(3-methoxy-3-oxopropyl)amino]propanoate
Details on test material:
- Name of test material (as cited in study report): T723
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): Not applicable
- Water (e.g. ad libitum): Not applicable
- Acclimation period: Not applicable


ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 32 +-1.5 deg C
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): No data


VEHICLE
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data
Duration of treatment / exposure:
Observations made at 60, 120, 180 and 240 minutes post dosing.
Observation period (in vivo):
60, 120, 180, 240 minutes post dosing
Number of animals or in vitro replicates:
five enucleated eyes for testing the substance; two enucleated eyes for the control (saline solution (0.9 % sodium chloride)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data

SCORING SYSTEM:
Cornea cloudiness was graded as follows:
0 = Normal cornea
1 = Some loss of transparency
2 = Moderate loss of transparency. In addition to involving the anterior stroma, the cloudiness extends all the way to the endothelium. The stroma has lost its marble-like appearance and is homogeneously white. With diffuse illumination, underlying structures are clearly visible.
3 = Involvment of the entire thickness of the stroma. With optical section, the endothelial surface is still visible. However with diffuse illumination the underlying structures are just visible.
4 = Involvment of the entire thickness of the stroma. With optical section, the endothelial surface cannot clearly visualise the endothelium. With diffuse illumination, the underlying structures cannot be seen.

The surface of the cornea relative to the area of cloudiness is divided into five grades from 0 to 4.
0 = Normal cornea with no area of cloudiness
1 = 1 to 25% area of stromal cloudiness
2 = 26 to 50% area of stromal cloudiness
3 = 51 to 75% area of stromal cloudiness
4 = 76 to 100% area of stromal cloudiness

TOOL USED TO ASSESS SCORE: fluorescein
0 = Absence of fluoresence staining
1 = Slight fluorescein staining confined to a small focus. With diffuse illumination the underlying structures are clearly visible, although there is some loss of detail.
2 = Moderate fluorescein staining confined to a small focus. With diffuse illumination the underlying structures are clearly visible, although there is some loss of detail.
3 = Marked fluorescein staining. Staining may involve a larger portion of the cornea. With diffuse illumination the underlying structures are barely visible but are not completely obliterated.
4 = Extreme fluorescein staining. With diffuse illumination the underlying structures cannot be seen.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
1 / mean of 3 eyes
Value:
0
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation parameter:
percent corneal swelling
Remarks:
60 min post dosing
Run / experiment:
1 / mean of 3 eyes
Value:
9
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation parameter:
percent corneal swelling
Remarks:
120 min post dosing
Run / experiment:
1 / mean of 3 eyes
Value:
11.3
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation parameter:
percent corneal swelling
Remarks:
240 min post dosing
Run / experiment:
1 / mean of 3 eyes
Value:
12.1
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation parameter:
other: fluorescein uptake
Remarks:
240 min post dosing
Run / experiment:
1 / mean of 3 eyes
Value:
0
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
not applicable
Other effects / acceptance of results:
Croneal epithelium corneal condition was norma al all time points for all test item treated eyes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Following the assessment of the data for all endpoints, the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.