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EC number: 208-060-1 | CAS number: 506-93-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-06-22 to 1988-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Guanidinium nitrate
- EC Number:
- 208-060-1
- EC Name:
- Guanidinium nitrate
- Cas Number:
- 506-93-4
- Molecular formula:
- CH6N4O3
- IUPAC Name:
- amino(imino)methanaminium nitrate
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Ammonium nitrate
- EC Number:
- 229-347-8
- EC Name:
- Ammonium nitrate
- Cas Number:
- 6484-52-2
- Molecular formula:
- H3N.HNO3
- IUPAC Name:
- Ammonium nitrate
- Reference substance name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- EC Number:
- 211-455-1
- EC Name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- Cas Number:
- 645-92-1
- Molecular formula:
- C3H5N5O
- IUPAC Name:
- 4,6-diamino-1,3,5-triazin-2(1H)-one
- Reference substance name:
- (4,6-Diamino-1,3,5-triazine-2-yl)guanidine
- Cas Number:
- 4405-08-7
- Molecular formula:
- C4H8N8
- IUPAC Name:
- (4,6-Diamino-1,3,5-triazine-2-yl)guanidine
- Reference substance name:
- Melamine
- EC Number:
- 203-615-4
- EC Name:
- Melamine
- Cas Number:
- 108-78-1
- Molecular formula:
- C3H6N6
- IUPAC Name:
- 1,3,5-triazine-2,4,6-triamine
- Reference substance name:
- Cyanoguanidine
- EC Number:
- 207-312-8
- EC Name:
- Cyanoguanidine
- Cas Number:
- 461-58-5
- Molecular formula:
- C2H4N4
- IUPAC Name:
- 1-cyanoguanidine
- Test material form:
- solid: crystalline
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands.
- Age at study initiation: 12 weeks
- Weight at study initiation: 2065 - 2390 g
- Housing: individually housed in a plastic cage with a perforated floor
- Diet: 100 g per day (LKK-20, diameter 4 mm) of standard laboratory animal diet obtained from Hope Farms, Woerden, The Netherlands
- Water: ad libitum, tap-water (via automatic nozzles):
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 55-75
- Photoperiod (hrs dark / hrs light): 12/12
One day before treatment, the fur was removed from the dorsal flanks of the animals by clipping, exposing an area of the skin of
approximately 10 cm x 10 cm.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- Milli-RO water (Millipore Corp., Bedford, Mass., USA)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g, moistened with 0.3 mL Milli-RO water
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
The exposed skin areas were examined for signs of erythema and oedema and the responses were scored approximately 60 minutes and 24, 48 and 72 hours after removal of the patches. - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Coverage: Each portion of the prepared test substance was spread on a 6 cm2 patch of Metalline (Lohmann, FRG) and mounted on permeable tape (Micropore, 3M, St.Paul, USA). This was applied to the left flank of each animal, the right flank being covered with the same dressing without test substance.
- Type of wrap used: flexible bandage (Coban, 3M, St. Paul, USA).
REMOVAL OF TEST SUBSTANCE
- Washing: The remaining test substance was removed using a dry tissue and subsequently a tissue moistened with tap-water.
- Time after start of exposure: 4 h
SCORING SYSTEM:
Erythema and eschar formation
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well—defined erythema
3: Moderate to severe erythema
4: Severe erythema (beef redness) to slight eschar formation (injuries in depth)
Oedema formation
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well defined by definite raising)
3: Moderate oedema (raised approximately 1 millimetre)
4: Severe oedema (raised more than 1 millimetre and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- The treated skin of all three animals was scored for erythema and oedema. The test substance caused no adverse effects to the skin, except very
slight erythema and very slight oedema in one animal 60 minutes after removal of the bandage. - Other effects:
- No signs of systemic intoxication were observed in any of the rabbits.
Any other information on results incl. tables
Summary Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Oedema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
0/0/1 |
0/0/1 |
24 h |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
Reversibility |
c/c/c |
c/c/c |
Average time (unit) for reversion |
24 h |
24 h |
Reversibility: c=completely reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility. In this study, the test substance Guanidine Nitrate is considered not to be irritant to the skin according to the criteria of:
- CLP - (EU GHS), Regulation (EC) No. 1272/2008
- OECD GHS (2nd rev. edition, UN, 2007)
- Directive 67/548/EEG . - Executive summary:
In a primary dermal irritation study according to OECD Guideline 404 1981, three White New Zealand rabbits were semi-occlusive dermally exposed to 0.5 g of Guanidine Nitrate for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.
Very slight erythema and oedema was observed in 1/3 animals 60 minutes after patch removal and was fully reversible after 24 hours.
No classification for skin irritation is required for Guanidine Nitrate according to CLP, EU GHS (Regulation (EC) No 1272/2008).
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