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EC number: 231-595-7 | CAS number: 7647-01-0
- 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
- Remarks:
- other: ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed on 14 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection : 10 July 2012 Date of Signature : 19 July 2013
Test material
- Reference substance name:
- Hydrochloric acid
- IUPAC Name:
- Hydrochloric acid
- Test material form:
- other: Liquid
- Details on test material:
- Sponsor's identification : Hydrochloric Acid
Description : clear colourless liquid
Lot number : SZBC1030V
Purity : 37.5%
Date received : 08 October 2012
Expiry date : 24 September 2015
Storage conditions : room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: Excised Bovine Cornea
- Strain:
- other: Strain: not applicable
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- other: Deionised Water
- Controls:
- no
- Amount / concentration applied:
- TEST ITEM
Concentrations prepared:
1%, 5% and 10% w/w in deionised water.
Amounts(s) applied (volume or weight with unit):
0.75 mL of the test item was applied to triplicate corneas.
VEHICLE
Deionised Water. - Duration of treatment / exposure:
- The test item dilutions were applied for 10 minutes followed by an incubation period of 120 minutes.
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
- Details on study design:
- TEST SITE
Area of exposure:
0.75 mL of each test item concentration was applied to each cornea.
PERCENTAGE COVERAGE:
The test item was topically applied to the cornea. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea.
EXPOSURE:
The test item dilutions were applied for 10 minutes followed by an incubation period of 120 minutes.
REMOVAL OF TEST ITEM
-Washing (if done):
At the end of the exposure period the test item concentrations 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.
EVALUATION OF RESULTS:
Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an In Vitro Irritancy Score.
Opacity Measurement:
The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting from each the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
Permeability Measurement:
The corrected OD492 was calculated by subtracting the mean OD492 of the negative control corneas from the OD492 value of each treated cornea. The OD492 value of each treatment group was calculated by averaging the corrected OD492 values of the treated corneas for the treatment group.
In Vitro Irritancy Score:
The following formula was used to determine the in vitro 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.
Visual Observation:
The condition of the cornea was visually assessed immediately after rinsing and at the final opacity measurement.
DATA INTERPRETATION:
An in vitro irritancy score greater than or equal to 55.1 is defined as an ocular corrosive or severe irritant.
Results and discussion
In vivo
Results
- Irritation parameter:
- cornea opacity score
- Basis:
- other: Mean Score of Opacity & Permeability
- Time point:
- other: 120 Minutes Post Rinsing
- Max. score:
- 1
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: See In Vitro Irritancy Scores below:
- Irritant / corrosive response data:
- Treatment In Vitro Irritancy Score
1% w/w Test Item 2.4
5% w/w Test Item 100.0
10% w/w Test Item 158.1
Negative Control 3.5
Positive Control 35.9
Vehicle Control 0.0 - Other effects:
- The corneas treated with 1% w/w test item were clear post treatment and post incubation. The corneas treated with 5% w/w and 10% w/w test item were cloudy post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation. The corneas treated with the vehicle control item were clear post treatment and post incubation.
Any other information on results incl. tables
RESULTS
Corneal Opacity and Permeability Measurement
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in Tables 1 and 2.Corneal Epithelium Condition
The condition of each cornea post treatment and post incubation is given in Tables 3 and 4. The corneas treated with 1% w/w test item were clear post treatment and post incubation. The corneas treated with 5% w/w and 10% w/w test item were cloudy post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation. The corneas treated with the vehicle control item were clear post treatment and post incubation.
In Vitro Irritancy Score
The results are summarised as follows:
Treatment |
In VitroIrritancy Score |
1% w/w Test Item |
2.4 |
5% w/w Test Item |
100.0 |
10% w/w Test Item |
158.1 |
Negative Control |
3.5 |
Positive Control |
35.9 |
Vehicle Control |
0.0 |
Criterion for an Acceptable Test
The positive control In Vitro Irritancy Score was within the range of 30.9 to 67.7. The positive control acceptance criterion was therefore satisfied.
Table 1 Individual and Mean Corneal Opacity and Permeability Measurements, Control Items
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In vitroIrritancy Score |
|||||
Pre-Treatment |
Post-Treatment |
Post-Incubation |
Post-Incubation-Pre‑Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
1 |
2 |
4 |
6 |
4 |
|
0.032 |
|
|
2 |
2 |
2 |
5 |
3 |
|
0.030 |
|
|
|
3 |
2 |
2 |
4 |
2 |
|
0.030 |
|
|
|
|
|
|
|
3.0* |
|
0.031 + |
|
3.5 |
|
Positive Control |
4 |
2 |
21 |
26 |
24 |
21.0 |
1.145 |
1.114 |
|
5 |
2 |
20 |
25 |
23 |
20.0 |
0.892 |
0.861 |
|
|
6 |
3 |
23 |
28 |
25 |
22.0 |
1.034 |
1.003 |
|
|
|
|
|
|
|
21.0· |
|
0.993· |
35.9 |
|
Vehicle Control |
7 |
2 |
3 |
5 |
3 |
0.0 |
0.039 |
0.008 |
|
8 |
3 |
4 |
5 |
2 |
0.0 |
0.018 |
0.000 |
|
|
9 |
1 |
2 |
2 |
1 |
0.0 |
0.018 |
0.000 |
|
|
|
|
|
|
|
0.0· |
|
0.003· |
0.0 |
OD= Optical density * = Mean of the post incubation - pre‑treatment values + = Mean permeability · = Mean corrected value
Table 2 Individual and Mean Corneal Opacity and Permeability Measurements, Test Item Dilutions
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In vitroIrritancy Score |
|||||
Pre-Treatment |
Post-Treatment |
Post-Incubation |
Post-Incubation-Pre‑Treatment |
Corrected Value |
|
Corrected Value |
|||
1%w/wTest Item |
10 |
3 |
9 |
9 |
6 |
3.0 |
0.028 |
0.000 |
|
11 |
3 |
6 |
7 |
4 |
1.0 |
0.030 |
0.000 |
|
|
12 |
2 |
6 |
8 |
6 |
3.0 |
0.049 |
0.018 |
|
|
|
|
|
|
2.3· |
0.006· |
2.4 |
|||
5%w/wTest Item |
13 |
1 |
40 |
96 |
95 |
92.0 |
0.025 |
0.000 |
|
14 |
2 |
43 |
98 |
96 |
93.0 |
0.083 |
0.052 |
|
|
15 |
3 |
55 |
120 |
117 |
114.0 |
0.043 |
0.012 |
|
|
|
|
|
|
|
99.7· |
|
0.022· |
100.0 |
|
10%w/wTest Item |
16 |
2 |
117 |
162 |
160 |
157.0 |
0.045 |
0.014 |
|
17 |
4 |
109 |
160 |
156 |
153.0 |
0.111 |
0.080 |
|
|
18 |
2 |
94 |
165 |
163 |
160.0 |
0.232 |
0.201 |
|
|
|
|
|
|
|
156.7· |
|
0.099· |
158.1 |
OD= Optical density ·= Mean corrected value
Table 3 Corneal Epithelium Condition Post Treatment and Post Incubation, Control Items
Treatment |
Cornea Number |
Observation |
|
Post Treatment |
Post Incubation |
||
Negative Control |
1 |
clear |
clear |
2 |
clear |
clear |
|
3 |
clear |
clear |
|
Positive Control |
4 |
cloudy |
cloudy |
5 |
cloudy |
cloudy |
|
6 |
cloudy |
cloudy |
|
Vehicle Control |
7 |
clear |
clear |
8 |
clear |
clear |
|
9 |
clear |
clear |
Table 4 Corneal Epithelium Condition Post Treatment and Post Incubation, Test Item Dilutions
Treatment |
Cornea Number |
Observation |
|
Post Treatment |
Post Incubation |
||
1% w/w Test Item |
10 |
clear |
clear |
11 |
clear |
clear |
|
12 |
clear |
clear |
|
5% w/w Test Item |
13 |
cloudy |
cloudy |
14 |
cloudy |
cloudy |
|
15 |
cloudy |
cloudy |
|
10% w/w Test Item |
16 |
cloudy |
cloudy |
17 |
cloudy |
cloudy |
|
18 |
cloudy |
cloudy |
Applicant's summary and conclusion
- Interpretation of results:
- other: Various Concentrations, see below:
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item was considered not to be an ocular corrosive or severe irritant at 1% w/w in deionised water and therefore did not require labelling as severe ocular irritant.
The test item was considered to be an ocular corrosive or severe irritant at 5% and 10% w/w in deionised water and therefore required to be classified as EU DSD Symbol “Xi” Risk Phrase R41, EU CLP and UN GHS H318 Category 1. - Executive summary:
- Introduction. A
study was performed to assess the ocular irritancy potential of various
concentrations of the test item, Hydrochloric acid, to the isolated bovine
cornea. The method was designed to be compatible with
the following:
OECD Guidelines for the Testing of Chemicals No. 437 (2009) “Bovine Corneal Opacity and Permeability Assay”
Preparation of Test Item: The sponsor was consulted prior to determination of the concentrations to be tested.
Concentrations prepared:
1%, 5% and 10% w/w in deionised water.Method. The test item dilutions were applied for 10 minutes followed by an incubation period of 120 minutes. Negative, positive and vehicle control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
Results. The in vitro Irritancy scores are summarised as follows:
Treatment
In Vitro Irritancy Score
1% w/w Test Item
2.4
5% w/w Test Item
100.0
10% w/w Test Item
158.1
Negative Control
3.5
Positive Control
35.9
Vehicle Control
0.0
Conclusion. The test item was considered not to be an ocular corrosive or severe irritant at 1% w/w in deionised water and therefore did not require labelling as severe ocular irritant.
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