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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06. Dec 2019 - 03. Apr 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- Deviations:
- yes
- Remarks:
- The observed differences in the environmental parameters were considered not to adversely affect the results or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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.: 18VL8610
Expiry Date: 06 October 2020
Storage Conditions: room temperature, protected from light
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Age of animals at starting: 9 weeks old
Body weight range at starting: 19.1 – 20.8 grams
Acclimatization time: 13 days
Animal health: Only healthy animals were used for the study. Health status was certified by the veterinarian.
The minimum /maximum values of temperature and relative humidity were recorded twice every day during the acclimatization and experimental phases.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 25% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- For the main assay, concentrations of 10% (w/v), 5% (w/v) and 2% (w/v) in DMSO were considered to be acceptable based on preliminary study results.
All mice were observed daily (until day 6) for any clinical signs of systemic toxicity or local irritation at the application site. Both ears of each mouse were observed for erythema and scored. Ear thickness was also measured using a thickness gauge on Day 1 (pre-dose), Day 3 (approximately 48 hours after the first dose) and Day 6. Additional quantification of the ear thickness was performed by ear punch weight determination after the euthanasia of the experimental animals. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Results were interpreted according to OECD Guideline 429
Results and discussion
- Positive control results:
- Valid: positive control substance produces a significant lymphoproliferative response increases (SI>3)
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 2.8
- Test group / Remarks:
- 10% (w/v) in DMS
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 5% (w/v) in DMS
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 2% (w/v) in DMS
- Cellular proliferation data / Observations:
- No mortality or systemic toxicity was observed during the main study. No test item residue was observed on the ears of the animals. There were no indications of any irritancy at the site of application.
No evidence of test item related effects were observed on the mean body weight changes in the main study
Any other information on results incl. tables
DPM. DPN and Stimulation Index Values for all Groups
Test Group Name |
Animal Number |
Measured DPM |
Total DPM |
No. of Nodes |
DPN |
Mean DPN |
Stimulation Index Values |
Background |
- |
36 |
- |
- |
- |
- |
- |
(5 (w/v) % TCA) |
|||||||
Negative control (DMSO) |
9372 |
482 |
446.0 |
2 |
223.0 |
391.0 |
1.0 |
9378 |
558 |
522.0 |
2 |
261.0 |
|||
9373 |
1541 |
1505.0 |
2 |
752.5 |
|||
9381 |
691 |
655.0 |
2 |
327.5 |
|||
GUP - Guanylurea Phosphate |
9377 |
1995 |
1959.0 |
2 |
979.5 |
1109.0 |
2.8 |
9386 |
2807 |
2771.0 |
2 |
1385.5 |
|||
9383 |
1597 |
1561.0 |
2 |
780.5 |
|||
9376 |
2617 |
2581.0 |
2 |
1290.5 |
|||
GUP - Guanylurea Phosphate |
9390 |
1117 |
1081.0 |
2 |
540.5 |
481.4 |
1.2 |
9385 |
1133 |
1097.0 |
2 |
548.5 |
|||
9384 |
1022 |
986.0 |
2 |
493.0 |
|||
9389 |
723 |
687.0 |
2 |
343.5 |
|||
GUP - Guanylurea Phosphate |
9374 |
965 |
929.0 |
2 |
464.5 |
510.0 |
1.3 |
9388 |
1372 |
1336.0 |
2 |
668.0 |
|||
9379 |
1509 |
1473.0 |
2 |
736.5 |
|||
9387 |
378 |
342.0 |
2 |
171.0 |
|||
Positive control |
9380 |
5377 |
5341.0 |
2 |
2670.5 |
3201.3 |
8.2 |
9382 |
6174 |
6138.0 |
2 |
3069.0 |
|||
9391 |
9959 |
9923.0 |
2 |
4961.5 |
|||
9375 |
4244 |
4208.0 |
2 |
2104.0 |
Notes:
1. Total DPM = Measured DPM – Background DPM value of TCA
2. DPN = (Measured DPM – Background DPM value of TCA) / Number of nodes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- GUP - Guanylurea Phosphate, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
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