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EC number: 202-571-3 | CAS number: 97-30-3
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- Aquatic toxicity
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- Short-term toxicity to fish
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- Irritation / corrosion
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-03-06 to 2017-05-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- July 26, 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- December 09, 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methyl α-D-glucoside
- EC Number:
- 202-571-3
- EC Name:
- Methyl α-D-glucoside
- Cas Number:
- 97-30-3
- Molecular formula:
- C7H14O6
- IUPAC Name:
- methyl α-D-glucoside
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Hubert Bahlmann GmbH & Co. Versandschlachterei Spezialmischfutterwerk KG, 49699 Lindern, Germany
- Number of animals: at least five, three corneae for each concentration (negative control, positive control, treatment)
- Characteristics of donor animals (e.g. age, sex, weight): between 6 and 12 month old cattle
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): To minimize deterioration and bacterial contamination, on collection the eyes were completely submerged in Hanks’ Balanced Salt Solution 2 (HBSS) containing penicillin at 100 IU/mL and streptomycin at 100 µg/mL.
- indication of any existing defects or lesions in ocular tissue samples: Upon arrival at the laboratory, the eyes were examined for defects such as but not limited to increased opacity, scratches, and neovascularisation. Only corneas from eyes free of defects were used.
- Indication of any antibiotics used: penicillin at 100 IU/mL and streptomycin at 100 µg/mL
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 20% suspension in 0.9% sodium chloride solution (w/v)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% suspension in 0.9% sodium chloride solution (w/v)
- Duration of treatment / exposure:
- 240 min
- Duration of post- treatment incubation (in vitro):
- 90 ± 5 min
- Number of animals or in vitro replicates:
- three corneae per treatment
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAE
Bovine eyes from cattle in the age range of 6 to 12 months were obtained from a slaughterhouse. To minimize deterioration and bacterial contamination, on collection the eyes were completely submerged in Hanks’ Balanced Salt Solution 2 (HBSS) containing penicillin at 100 IU/mL and streptomycin at 100 µg/mL 3 . Upon arrival at the laboratory, the eyes were examined for defects such as but not limited to increased opacity, scratches, and neovascularisation. Only corneas from eyes free of defects were used.
NUMBER OF REPLICATES
Three coneae per concentration
SOLVENT CONTROL USED (if applicable)
0.9 % sodium chloride solution (w/v)
POSITIVE CONTROL USED
20% Imidazole in 0.9% sodium chloride solution
APPLICATION DOSE AND EXPOSURE TIME
750 µL of each solution was applied for 240 min
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least three times
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea measured quantitatively with the aid of an opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The IVIS cut-off values for identifying test chemicals as inducing serious damage (UN GHS Category 1) and test chemicals not requiring classification for irritation or serious eye damage (UN GHS No Category):
≤ 3: No Category
> 3 and ≤ 55: No prediction can be made
> 55: Category 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 2.097
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- -1.99
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 1
- Value:
- -0.007
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes. The negative or solvent/vehicle control responses should result in opacity and permeability values, that are less than the established upper limits for background opacity and permeability values for bovine corneas treated with the respective negative or solvent/vehicle control. (see Table 1)
- Acceptance criteria met for positive control: Yes. The positive control should give an IVIS that falls within two standard deviations of the current historical mean. (see Table 1)
- Range of historical values if different from the ones specified in the test guideline: No
Any other information on results incl. tables
Table 1: Historical control data
|
Parameter |
Mean |
Standard deviation |
Lower limit of acceptance (mean-2*SD) |
Upper limit of acceptance (mean+2*SD) |
NaCl 0.9 % |
IVIS Opacity |
0.812 0.513 |
0.762 0.788 |
-0.712 -1.064 |
2.336 2.089 |
|
Permeability |
0.020 |
0.012 |
-0.005 |
0.045 |
Imidazol 20% |
IVIS Opacity |
86.039 63.051 |
10.607 10.709 |
64.826 41.634 |
107.253 84.468 |
|
Permeability |
1.533 |
0.463 |
0.607 |
2.458 |
Table 2: Summary of results after 240 min incubation
Test group |
Opacity |
Permeability at 490 nm |
In vitro Irritation score |
Mean In vitro Irritation Score |
In vitro Irritation Scale |
Negative control |
0.917 |
0.010 |
1.067 |
|
Not severely irritating |
-0.797 |
0.011 |
-0.632 |
|
||
-0.358 |
0.010 |
-0.208 |
0.076 |
||
Positive control |
73.505 |
1.403 |
94.629 |
|
Severely irritating |
49.323 |
1.204 |
67.462 |
|
||
54.463 |
1.372 |
75.122 |
79.071 |
||
Test item |
-2.032 |
0.006 |
-2.043 |
|
Not severely irritating |
-2.031 |
0.005 |
-2.027 |
|
||
-2.151 |
-0.010 |
-2.222 |
-2.097 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study with alpha methyl glucoside conducted according to OECD guideline 437, three corneae for each treatment, i.e. negative control, positive control (20% imidazol in 0.9 % sodium chloride solution (w/v)) and treatement (20% alpha methyl glucoside in 0.9 % sodium chloride solution (w/v)) were exposed for 240 min. Opacity and permeability revealed values < 0 and the IVIS was < 3 (2.097), therefore, the test item is not classified according to UN GHS classification.
- Executive summary:
In the present study with alpha methyl glucoside conducted according to OECD guideline 437, three corneae for each concentration, i.e. negative control, positive control (20% imidazol in 0.9 % sodium chloride solution (w/v)) and treatement (20% alpha methyl glucoside in 0.9 % sodium chloride solution (w/v)) were exposed for 240 min. Subsequently the opacity was determined using a opacitometer and the corneal permeability was detected with the fluorescein method.
The positive control increased opacity and permeability (mean in vitro score 79.07) corresponding to a classification as irreversible effects to the eye.
With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean in vitro score 0.00).
Since, the results of the test item for opacity and permeability revealed values < 0 and the IVIS was < 3 (2.097) the test item is not classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
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