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EC number: 226-798-2 | CAS number: 5470-11-1
- 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:
- weight of evidence
- Study period:
- 27 Nov 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- / no raw (uncorrected) and no mean values for opacity and permeability
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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:
- 26 July 2013
- Deviations:
- yes
- Remarks:
- / no raw (uncorrected) and no mean values for opacity and permeability
- 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:
- 08 Dec 2010
- Deviations:
- yes
- Remarks:
- / no raw (uncorrected) and no mean values for opacity and permeability
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- Hydroxylammonium chloride
- EC Number:
- 226-798-2
- EC Name:
- Hydroxylammonium chloride
- Cas Number:
- 5470-11-1
- Molecular formula:
- ClH.H3NO
- IUPAC Name:
- hydroxyammonium chloride
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: tightly closed, in the dark, at room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid: 20% (w/v) in a 0.9% sodium chloride solution
FORM AS APPLIED IN THE TEST (if different from that of starting material)
liquid
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Odenwaldschlachthof Brensbach, Brensbach, Germany
- Characteristics of donor animals (e.g. age, sex, weight): 17 - 43 months
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The isolated eyes were transported in HBSS (with streptomycin/ penicillin (0.01%)), ice cooled.
- Time interval prior to initiating testing: The comeas were prepared immediately upon arrival.
- indication of any existing defects or lesions in ocular tissue samples: no
- Indication of any antibiotics used: streptomycin/ penicillin
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL (= 150 mg)
- Concentration (if solution): 20% w/v in vehicle
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 μL
- Concentration (if solution): 0.9% w/v
- Lot/batch no. (if required): 144440 16
- Purity: 0.9% - Duration of treatment / exposure:
- 4 h at 32 ± 1 °C
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- Number of eyes for the test item/ negative control/ positive control: 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: A careful macroscopic examination was performed on all eyes to detect the presence of any defects. Only corneas free of damage were used. The cornea was removed from the eye leaving a rim of about 2 to 3 mm of sclera. The isolated corneas were immersed in pre-warmed HBSS (32 ± 1°C) until they were mounted in BCOP holders. A pre-treatment opacity reading was taken for each cornea.
QUALITY CHECK OF THE ISOLATED CORNEAS: Yes, the eyes were free of defects.
NUMBER OF REPLICATES: 3
SOLVENT CONTROL USED: Yes, sodium chloride (0.9% w/v)
POSITIVE CONTROL USED: Yes, imidazole (20% in sodium chloride (0.9% w/v))
APPLICATION DOSE AND EXPOSURE TIME: 750 μl test item (20%), 4 h
TREATMENT METHOD: closed chamber: The test item solution, negative control and positive control were introduced into the anterior chamber through the dosing holes of the chamber. Afterwards, the corneas were incubated for 4 h in an incubator in a horizontal position.
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: The cornea was rinsed three times with EMEM containing phenol red and one time with EMEM without phenol red.
- POST-EXPOSURE INCUBATION: no
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: A baseline opacity was determined as well as the post-exposure opacity.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microplate reader (ELx800, BioTek Instruments GmbH, Bad Friedrichshall, Germany) at 490 nm
- Others (e.g, pertinent visual observations, histopathology): In addition each cornea was visually observed.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The decision criteria as indicated in the TG (OECD 437) and in "Any other information on materials and methods incl. tables" was used.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- negative control - cornea 1
- Value:
- -0.062
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- negative control - cornea 2
- Value:
- 1.816
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- negative control - cornea 3
- Value:
- 0.706
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- positive control - cornea 1
- Value:
- 70.793
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- positive control - cornea 2
- Value:
- 71.315
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- positive control - cornea 3
- Value:
- 79.27
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test item - cornea 1
- Value:
- 57.755
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test item - cornea 2
- Value:
- 47.875
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test item - cornea 3
- Value:
- 25.708
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- negative control - mean out of all 3 eyes
- Value:
- -0.001
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- positive control - cornea 1
- Value:
- 2.142
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- positive control - cornea 2
- Value:
- 2.303
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: value is corrected
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- positive control - cornea 3
- Value:
- 2.119
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- test item - mean out of all 3 eyes
- Value:
- -0.002
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- negative control - mean out of all 3 eyes
- Value:
- 0.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- positive control - mean out of all 3 eyes
- Value:
- 106.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- test item - mean out of all 3 eyes
- Value:
- 43.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY: yes, using Phenylbutazone (not classified) and Dibenzoyl-L- tartaric acid (Cat. 1)
ACCEPTANCE OF RESULTS:
The test is acceptable if the positive control produces an IVIS which falls within two standard deviations of the current historical mean (for this testing facility: 75.5 - 137.3).
The negative control responses should result in an IVIS that falls within three standard deviations of the current historical mean (for this testing facility: -1.4 - 3.5).
A single test run with three corneas should be suffcient for a test item when the resulting classification is unequivocal.
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Table 1: Results of BCOP test
Parameter |
Opacity |
Permeability [OD490] |
IVIS |
||
per cornea |
per group (mean) |
SD |
|||
Negative control |
-0.062 |
-0.001 |
-0.082 |
0.8 |
0.9 |
1.816 |
-0.001 |
1.801 |
|||
0.706 |
-0.001 |
0.696 |
|||
Positive control |
70.793 |
2.142 |
102.928 |
106.6 |
4.1 |
71.315 |
2.303 |
105.860 |
|||
79.270 |
2.119 |
111.060 |
|||
Test item |
57.755 |
-0.002 |
57.725 |
43.7 |
16.4 |
47.875 |
-0.002 |
47.850 |
|||
25.708 |
-0.002 |
25.673 |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive (Eye Irrit. 2 or not classified according to Regulation (EC) No 1272/2008)
- Conclusions:
- Under the conditions of the test, the test substance was shown to have no corrosive potential in the Bovine corneal opacity and permeability (BCOP) test prediction model. The result does not allow for the non-classification or classification as irritant of the test substance and therefore further evaluation and/or data generation is required.
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