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EC number: 241-659-6 | CAS number: 17675-60-4
- 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:
- 20-03-2017 to 16-05-2017
- 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals, number 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” (adopted: 26 July 2013)
- Deviations:
- yes
- Remarks:
- minor deviations that did not influence the quality or integrity of the present study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amidinourea phosphate
- EC Number:
- 241-659-6
- EC Name:
- Amidinourea phosphate
- Cas Number:
- 17675-60-4
- Molecular formula:
- C2H6N4O.xH3O4P
- IUPAC Name:
- diaminomethylideneurea;phosphoric acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 16VL8189
Expiry Date: 03 August 2017
Storage Conditions: room temperature, protected from light
Test animals / tissue source
- Species:
- other: Bovine eyes were collected from a slaughterhouse.The eyes were examined for defects, defective eyes were discarded. The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera.
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS. Before the corneas were mounted in corneal holders (Duratec GmbH) with the endothelial side against the O-ring of the posterior chamber, they had been visually examined for defects and any defective cornea had been discarded. The anterior chamber was then positioned on top of the cornea and tightened with screws. The chambers of the corneal holder were then filled with RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber was always filled first. The corneas were incubated for one hour at 32 1 °C.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL of the test item applied (The test item was suspended with physiological saline 0.9% NaCl to give a 20% concentration.
- Duration of treatment / exposure:
- 4 hours ± 5 minutes
- Observation period (in vivo):
- Not applicable
- Duration of post- treatment incubation (in vitro):
- 90 minutes
- Number of animals or in vitro replicates:
- 3 per group
- Details on study design:
- See any other information on materials and methods
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 3.58
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No prediction can be made regarding the classification of the test substance GUP according to the evaluation criteria.
Any other information on results incl. tables
In vitro irritation score
Cornea | Test Item | Corrected | Corrected OD490 Value | IVIS |
No. | Opacity | |||
1 | Negative control | 0.43 | 0.004 | |
2 | 2.21 | 0.014 | ||
3 | 1.32 | 0.016 | ||
MV | 1.32 | 0.011 | 1.49 | |
4 | Positive control | 133.12 | 0.861 | |
5 | 122.92 | 2.069 | ||
6 | 129.61 | 1.078 | ||
MV | 128.55 | 1.336 | 148.59 | |
7 | Test Item | 1.96 | 0.008 | |
8 | 3.17 | 0.011 | ||
9 | 4.45 | 0.058 | ||
MV | 3.2 | 0.025 | 3.58 |
MV = mean value
IVIS = in vitro irritation score
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No prediction can be made regarding the classification of the test substance GUP according to the evaluation criteria.
- Executive summary:
The eye irritancy potential of GUP was investigated in the bovine corneal opacity and permeability assay. The test item was suspended with physiological saline 0.9% NaCl (see 10.2) to give a
20% concentration. All 3 corneas treated with GUP showed slight opacity of the tissue. The following mean in vitro irritation score was calculated: 3.58.
No prediction can be made regarding the classification of the test substance GUP according to the evaluation criteria.
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses should result in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
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