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EC number: 241-221-4 | CAS number: 17169-60-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- 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:
- 2019-10-10 to 2019-12-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- 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)
- Version / remarks:
- October 2017
- 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:
- February 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Series on Testing and Assessment No. 160
- Version / remarks:
- “GUIDANCE DOCUMENT ON “THE BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) AND ISOLATED CHICKEN EYE (ICE) TEST METHODS: COLLECTION OF TISSUES FOR HISTOLOGICAL EVALUATION AND COLLECTION OF DATA ON NON-SEVERE IRRITANTS”; 25. Oct. 2011
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrogen (glycinato-N,O)[sulphato(2-)-O,O']ferrate(1-)
- EC Number:
- 241-221-4
- EC Name:
- Hydrogen (glycinato-N,O)[sulphato(2-)-O,O']ferrate(1-)
- Cas Number:
- 17169-60-7
- Molecular formula:
- C2H5FeNO6S
- IUPAC Name:
- 2-aminoacetate;hydron;iron(2+);sulfate
- Test material form:
- solid: granular
- Details on test material:
- Name: Ferrous monoglycinate sulfate
Date of Receipt: 13. Nov. 2019
Condition at Receipt: Ambient temperature, in proper conditions
Appearance: beige to light brown granule
Homogeneity: homogeneous
Purity: > 97 % Fe-Complex
Storage: room temperature (20 ± 5 °C)
Stability: stable under storage conditions
CAS No. 52139-31-8
EC-No. 241-221-4
Chemical Class: organometallic complex
Volatility: no
pH-value: not stated
Surface activity: no
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: slaughterhouse Müller Fleisch GmbH, Industriestraße 42, 75217 Birkenfeld, Germany
- Number of animals: not specified
- Characteristics of donor animals (e.g. age, sex, weight): between 12 and 60 months old
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour and 10 minutes.
- Time interval prior to initiating testing: 1 h
- indication of any existing defects or lesions in ocular tissue samples: only corneas which were free from damages were used
- Indication of any antibiotics used: no
Test system
- Vehicle:
- Hank's balanced salt solution
- 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 % (w/v)
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- 4 h
- Duration of post- treatment incubation (in vitro):
- 90 min
- Number of animals or in vitro replicates:
- 3 corneas
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: After the arrival of the corneas, they were examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1 °C. After the initial incubation, the medium was completely changed and the baseline opacity for each cornea was recorded.
QUALITY CHECK OF THE ISOLATED CORNEAS: None of the corneas showed tissue damage; therefore, all corneas were used.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: yes, concurrent vehicle
POSITIVE CONTROL USED: yes, Imidazole, 20 % solution in HBSS
APPLICATION DOSE AND EXPOSURE TIME: 750 µL each for 4 h
TREATMENT METHOD: closed chamber for controls. Open chamber for test item suspension.
POST-INCUBATION PERIOD: yes, 90 min
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: thorough rinsing
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD492)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: as indicated in the TG.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1-3
- Value:
- 3.25
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Findings and Results
Opacity and Permeability Values
The illuminance (unit: LUX) values which were measured before and after exposure are given in the following table:
Table 1: Illuminance Values. Rep. = Replicate
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
(I) Measured values before exposure |
1051 |
1056 |
1057 |
1030 |
1037 |
1047 |
1017 |
1027 |
1028 |
(I) Measured values after exposure |
1039 |
966 |
1026 |
915 |
909 |
942 |
350 |
389 |
366 |
The values in the following tables present the calculated opacity values, according to evaluation.
Table 2: Opacity Values Negative Control. Rep. = Replicate
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
2.10 |
1.90 |
1.86 |
Opacity after exposure |
2.58 |
5.75 |
3.11 |
Opacity Difference |
0.48 |
3.85 |
1.25 |
Mean Opacity Difference |
1.86 |
Table 3: Opacity Values Test Item and Positive Control. Rep. = Replicate.
Parameter |
Test Item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
2.66 |
2.46 |
2.30 |
3.49 |
3.07 |
3.03 |
Opacity |
6.22 |
6.66 |
5.61 |
85.25 |
72.75 |
79.80 |
Opacity |
3.57 |
4.20 |
3.31 |
81.76 |
69.68 |
76.77 |
Opacity corrected |
1.71 |
2.34 |
1.46 |
79.90 |
67.82 |
74.91 |
Mean Opacity corrected |
1.83 |
74.21
|
For the permeability measurement, three replicates for each treatment group were measured three times. cMEM without phenol red was measured as blank value as well. The optical density values at 492 nm are given in the following tables:
Table 4: Optical density at 492 nm of Blank.
Parameter |
cMEM without phenol red |
1. Measurement |
0.037 |
2. Measurement |
0.037 |
3. Measurement |
0.034 |
Mean |
0.036 |
Table 5: Optical density at 492 nm of Negative Control, Test Item and Positive Control. Rep. = Replicate. * Note: Two replicates for the positive control were obtained by measurement of a fivefold diluted solution and multiplication of the absorbances with factor 5.
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
1.Measure-ment |
0.052 |
0.053 |
0.047 |
0.040 |
0.039 |
0.036 |
1.771 |
0.638 |
0.599 |
2.Measure-ment |
0.052 |
0.055 |
0.046 |
0.041 |
0.038 |
0.038 |
1.746 |
0.690 |
0.589 |
3.Measure-ment |
0.052 |
0.054 |
0.048 |
0.040 |
0.039 |
0.037 |
1.769 |
0.685 |
0.060 |
|
|||||||||
1.Measure-ment – blank |
0.0160 |
0.0170 |
0.0110 |
0.0040 |
0.0030 |
0.0000 |
1.7350 |
0.6020 |
0.5630 |
2.Measure-ment – blank |
0.0160 |
0.0190 |
0.0100 |
0.0050 |
0.0020 |
0.0020 |
1.7100 |
0.6540 |
0.5530 |
3.Measure-ment – blank |
0.0160 |
0.0180 |
0.0120 |
0.0040 |
0.0030 |
0.0010 |
1.7330 |
0.6490 |
0.0236 |
Mean of each replicate |
0.0160 |
0.0180 |
0.0110 |
0.0043 |
0.0027 |
0.0010 |
1.7260 |
0.6350 |
0.3799 |
Mean of the 3 replicates |
0.0150 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
-0.0107 |
-0.0123 |
-0.0140 |
1.7110 |
3.1600* |
1.8843* |
Corrected mean of the 3 replicates |
-- |
-0.0123 |
2.2518 |
IVIS Values
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table 6: IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.72 |
2.08 |
86.23% |
4.12 |
|||
1.41 |
|||
Test Item |
3.31 |
3.25 |
20.09% |
3.88 |
|||
2.58 |
|||
Positive Control |
105.57 |
107.99 |
5.91% |
115.22 |
|||
103.18 |
Note: the high relative standard deviations of the IVIS of the negative control and test item are due to mathematical reasons, as the respective means are very small.
Validity
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The mean IVIS of the negative control has to show an IVIS ≤ 3.
The validity criteria and findings are given in the following table:
Table 7: Validity
Parameter |
Criterion |
Found |
Assessment |
Mean IVIS of negative control HBSS |
≤ 3 |
2.08 |
ok |
Mean IVIS of positive control |
75.63 – 146.38 |
107.99 |
ok |
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.
Assessment
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
Table 8: Classification Scheme
IVIS |
UN GHS |
≤ 3 |
No category |
> 3 and ≤ 55 |
No prediction can be made |
> 55 |
Eye damage Category I |
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS category I.
The test item showed effects on the cornea of the bovine eye. The calculated mean IVIS was 3.25.
The experiment is considered valid, because two of the three replicates of the test item lead to the same assessment for the test item.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this ex vivo study (BCOP according to OECD guideline 437; adopted October 2017), a 20 % suspension of ferrous monoglycinate sulfate in HBSS induced a minimal relative increase of the corneal opacity and permeability as compared to negative control. The calculated mean in vitro score was 3.25, which lies in the range of IVIS > 3 and ≤ 55 which does not allow classification according to UH GHS.
- Executive summary:
In this ex vivo study according to OECD guideline no. 437 (Oct. 2017, the corneal damage potential of ferrous monoglycinate sulfate was assessed by quantitative measurements of changes in opacity and permeability in a bovine cornea.
Bovine corneas were collected from slaughtered cattle that were between 12 and 60 months old.
The test item was applied onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured.
The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Irritancy Score) was 2.08.
20 % imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated mean IVIS was 107.99.
Under the conditions of this study, the test item ferrous monoglycinate sulfate showed effects on the cornea of the bovine eye. The calculated mean IVIS was 3.25.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage with the BCOP study only. In this case, no prediction can be made.
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