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Diss Factsheets
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EC number: 217-468-9 | CAS number: 1863-63-4
- 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:
- 6. Mar. 2017 - 27. Jun. 2017
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ammonium benzoate
- EC Number:
- 217-468-9
- EC Name:
- Ammonium benzoate
- Cas Number:
- 1863-63-4
- Molecular formula:
- C7H6O2.H3N
- IUPAC Name:
- ammonium benzoate
- Test material form:
- solid: crystalline
- Details on test material:
- - State of aggregation: solid
- Particle size distribution: median particle size D50 = 98 µm
- Mass median aerodynamic diameter (MMAD): not determined
- Geometric standard deviation (GSD): not determined
- Shape of particles: not determined
- Surface area of particles: not determined
- Crystal structure: not determined
- Coating: none
- Surface properties: none known
- Density: 1.26
- Moisture content: ca. 1.5 %
- Residual solvent: none known
- Activation: none
- Stabilisation: none
- Other: none
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 608031
- Expiration date of the lot/batch: 25. Oct. 2018
- Purity test date: not stated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored in the test facility in a closed vessel at room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: assumed soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: assumend none
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none
Test animals / tissue source
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability: test system according international accepted Guideline
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live:
The EpiOcular tissue consists of normal, uman-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells. These cells are not transformed or transfected with genes to induce an extended life span. The EpiOcular tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells. The tissue surface is 0.6 cm2.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50.7 mg and 50.5 mg
- Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used
according to OECD Guideline
- RhCE tissue construct used, including batch number
EpiOcularTM tissue, Batch No.: 23773
- Doses of test chemical and control substances used
ca. 50 mg test substance, 50 µL controls
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable)
exposure: 6 hours
post-exposure: 48 hours
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable)
MTT reduction potential and staining properties tested
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable)
2
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer)
570 nm
- Description of the method used to quantify MTT formazan
isopropanol extract
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
> 60 % viability: Non eye irritant
=< 60 % viability: Eye irritant
- negative and positive control values within range of historical data
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: viability
- Run / experiment:
- Tissue 1
- Value:
- 0.034
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: viability
- Run / experiment:
- Tissue 2
- Value:
- 0.03
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria for negative control: OD between 0.8 and 2.5
- Found value: 1,5
- Acceptance criteria met for positive control: < 50% of negative control
- Found value: 42.1 %
- Range of historical values if different from the ones specified in the test guideline:
For negative control: 1.526 +- 0.249
For positive control: 32.4 % +- 8.3 %
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the test, Ammonium Benzoate is considred as either eye irritant or inducing serious eye damage in the EpiOcular Eye Irritation Test. A differenciation between GHS category 1 or 2 is not possible.
- Executive summary:
One valid experiment was performed.
The test item Ammonium Benzoate was applied to a three-dimensional human cornea tissue
model in duplicate for an exposure time of 6 hours.
The solid test item was applied to each tissue.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of
the tissues was evaluated by addition of MTT, which can be reduced to formazan. The
formazan production was evaluated by measuring the optical density (OD) of the resulting
solution.
Demineralised water was used as negative control and methyl acetate was used as positive
control.
The controls showed the following results: After treatment with the negative control, the
absorbance values were within the required acceptability criterion of mean OD > 0.8 and <
2.5, OD was 1.5. The positive control showed clear eye irritating effects, the relative absorbance
value was reduced to 42.1 % (< 50%).
Variation within tissue replicates was acceptable (< 20%).
After treatment with the test item, the mean value of tissue viability was 2.1 %.
This value is below the threshold for eye irritation potential (≤ 60%).
According to the OECD Guideline 492, the EpiOcularTM Eye Irritation Test does not allow
discrimination between eye irritation/reversible effects on the eye (Category 2) and serious
eye damage/irreversible effects on the eye (Category 1). For these purposes, further testing
with other suitable test methods may be required.
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