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EC number: 940-441-4 | CAS number: -
- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
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- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Valid and conclusive guideline study under GLP; Relevant and adequate for this endpoint
- Justification for type of information:
- The Reporting Format for the Chemical Category According to ECHA (2008) Guidance R.6.2.6.2 can be found in the Endpoint Summary of Toxicokinetics, metabolism and distribution.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Statement of compliance in accordance with Directive 2004/9/EC, Department of Health of the Government of the U.K., 12 September 2014, inspection date 12 to 14 March 2014
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Hydronium Jarosite
- Substance type: Inorganic chemical
- Physical state: Light brown solid
- Analytical purity: > 97 %
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: an isolated bovine cornea was used in vitro
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Source: Eyes were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee and placed in Hanks’ Balanced Salt Solution (HBSS), supplemented with Penicillin and Streptomycin, and transported to the laboratory on ice packs. The corneas were refrigerated on arrival and used within 24 hours of receipt.
- Age at study initiation: The eyes were taken from adult cattle
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32±1
Test system
- Vehicle:
- physiological saline
- Controls:
- other: 3 replicates were used in the positive control and also in the negative control
- Amount / concentration applied:
- TEST MATERIAL & VEHICLE
- Amount(s) applied: 0.75 mL of the test item preparation or control items were applied to the appropriate corneas
- Concentration: For the purpose of this study the test item was prepared as a 20 % w/v solution in 0.9 % w/v sodium chloride solution.
VEHICLE
- Lot/batch no: 300999 104
- Purity: 0.9 % - Duration of treatment / exposure:
- 240 min
- Observation period (in vivo):
- The results were recorded immediately after exposure as the In Vitro system cannot recover.
- Number of animals or in vitro replicates:
- 3 replicates were used in the treatment group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period the test item preparation and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM. The anterior and posterior chambers were refilled with fresh complete MEM. RThen a post treatment opacity reading was taken.
- Time after start of exposure: 240 min
SCORING SYSTEM:
The following formula was used to determine the In Vitro Irritancy Score:
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
Additionally, the opacity and permeability values were evaluated independently to determine whether the test item induced a response through only one of the two endpoints.
TOOL USED TO ASSESS SCORE
- Opacity Measurement: Opacity reading was taken for each cornea using a calibrated opacitometer.
- Permeability Measurement: Optical density at 492 nm (OD492) was measured using the Anthos 2001 microplate reader.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In Vitro Irritancy Score
- Basis:
- mean
- Remarks:
- of 3 replicates
- Time point:
- other: 240 minutes
- Score:
- 10.6
- Max. score:
- 14.25
- Reversibility:
- other: not applicable
- Remarks on result:
- other: In Vitro Irritancy Score = mean opacity value + (15 · mean OD492 value)
- Irritant / corrosive response data:
- - Corneal Opacity and Permeability Measurement: Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in Table 1.
- Corneal Epithelium Condition: The condition of each cornea post treatment and at the final opacity measurement is given in Table 2. The corneas treated with the test item were slightly cloudy post treatment. The corneas treated with the negative control item were clear post treatment. The corneas treated with the positive control item were cloudy post treatment.
- In Vitro Irritancy Score of the controls: Negative Control 2.6; Positive Control 90.6
Any other information on results incl. tables
Table 1: Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea number |
Opacity |
Permeability (OD) |
In Vitro Irritancy Score |
||||
Pre-Treatment |
Post-Treatment |
Score Post-Treatment - Pre-Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
17 |
2 |
4 |
2 |
|
0.036 |
|
|
18 |
2 |
4 |
2 |
|
0.050 |
|
|
|
19 |
2 |
4 |
2 |
|
0.034 |
|
|
|
|
|
|
2.0* |
|
0.040# |
|
2.6 |
|
Positive Control |
14 |
2 |
79 |
77 |
75.0 |
1.180 |
1.140 |
|
15 |
2 |
66 |
64 |
62.0 |
1.944 |
1.904 |
|
|
16 |
4 |
79 |
75 |
73.0 |
1.111 |
1.071 |
|
|
|
|
|
|
70.0§ |
|
1.372§ |
90.6 |
|
Test Item |
11 |
3 |
17 |
14 |
12.0 |
0.190 |
0.150 |
|
12 |
3 |
12 |
9 |
7.0 |
0.147 |
0.107 |
|
|
13 |
3 |
14 |
11 |
9.0 |
0.024 |
0.000 |
|
|
|
|
|
|
9.3§ |
|
0.086§ |
10.6 |
OD = Optical density
* = Mean of the post-treatment - pre-treatment values ¨
# = Mean permeability
§ = Mean corrected value
Table 2: Corneal Epithelium Condition Post Treatment
Treatment |
Cornea Number |
Observation |
Post Treatment |
||
Negative Control |
17 |
clear |
18 |
clear |
|
19 |
clear |
|
Positive Control |
14 |
cloudy |
15 |
cloudy |
|
16 |
cloudy |
|
Test Item |
11 |
slightly cloudy |
12 |
slightly cloudy |
|
13 |
slightly cloudy |
Applicant's summary and conclusion
- Interpretation of results:
- other: The test item was considered not to be an ocular corrosive or severe, but this does not permit conclusion that the test item does not require classification for eye irritation.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The result of this study has identified the test item as not causing serious eye damage, but poentially being an eye irritant.
- Executive summary:
The in vitro eye irritation potential of the test item Hydronium Jarosite to the isolated bovine cornea was investigated in a GLP-compliant study according to the OECD TG 437 (2009) protocol. The experiment can be considered valid, relevant and adequate for final conclusion on the presence or absence of corrosive (UN-GHS category 1) and/or irritant (UN-GHS category 2) properties. Therefore it can be deemed conclusive for presence of absence of non-irritancy and was rated „reliable without restrictions“, i.e. “Klimisch 1” according to the scale of Klimisch et al. (1997).
The test system consisted of eyes taken from adult cattle. Three replicates each were exposed during 240 min at 32±1 °C to 0.75 mL of the test item preparation or control items. The test item was prepared as a 20 % w/v solution in 0.9 % w/v sodium chloride solution, which served without test item as negative control (physiological saline). The positive control item, Imidazole, was used as a 20 % w/v solution in 0.9 % w/v sodium chloride solution. A test item that induces an In Vitro Irritancy Score ≥ 55.1 is defined as an ocular corrosive or severe irritant and will be labelled EU DSD (67/548/EEC) R41 and EU CLP/UN GHS Category 1. In absence of effects a substance can be considered no classifiable.
The In Vitro Irritancy Score of the negative control was 2.6, while the positive control attained 90.6. Therefore the usability of the test system was confirmed. The mean score of the test item was 10.6 (max. 14.25). The corneas treated with the test item were slightly cloudy post treatment. The corneas treated with the negative control item were clear post treatment. The corneas treated with the positive control item were cloudy post treatment.
In conclusion, based on this study alone, the test item was considered not to be an ocular corrosive or severe, but this does not permit conclusion that the test item does not require classification for eye irritation.
- Klimisch HJ, Andreae M, Tillmann U (1997). A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data. DOI 10.1006/rtph.1996.1076 PMID 9056496 Regul Toxicol Pharmacol 25:1-5.
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