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EC number: 209-143-5 | CAS number: 556-88-7
- 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:
- September 1984 - April 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 560/6-82-001
- Deviations:
- yes
- Remarks:
- (The rabbits were weighed on 3 October instead of 2 October. This had no effect on the results of the study. )
- GLP compliance:
- yes
- Remarks:
- GLP Study Report
Test material
- Reference substance name:
- 1-nitroguanidine
- EC Number:
- 209-143-5
- EC Name:
- 1-nitroguanidine
- Cas Number:
- 556-88-7
- Molecular formula:
- CH4N4O2
- IUPAC Name:
- N-nitroguanidine
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- Na2O4S
- IUPAC Name:
- disodium sulfate
- Reference substance name:
- Sodium nitrate
- EC Number:
- 231-554-3
- EC Name:
- Sodium nitrate
- Cas Number:
- 7631-99-4
- Molecular formula:
- HNO3.Na
- IUPAC Name:
- sodium 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:
- 6-amino-1,3,5-triazine-2,4(1H,3H)-dione
- EC Number:
- 211-456-7
- EC Name:
- 6-amino-1,3,5-triazine-2,4(1H,3H)-dione
- Cas Number:
- 645-93-2
- Molecular formula:
- C3H4N4O2
- IUPAC Name:
- 6-amino-1,3,5-triazine-2,4(1H,3H)-dione
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
- Specific details on test material used for the study:
- Test substance supplier Sunflower AAP
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elkhorn Rabbitry, Watsonville, CA; U.S.A.
- Age at study initiation: young adults
- Weight at study initiation: 3.2-3.6 kilograms
- Housing: individually in stainless steel, screenbottomed, battery-type cages with automatically flushing dump tanks
- Diet: 150 g/d Certified Purina Chow Diet 5322 (Ralsotn Purina Company, St.Loius, MO)
- Water (e.g. ad libitum): tap water
- Acclimation period: for 5 days prior to testing following a 14 day quarantine, during this period they were observed daily for signs of illness
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-20.0 °C
- Humidity (%): 40-70%
- Air changes (per h): no data
- Photoperiod (hrs dark/hrs light): 12/12
IN-LIFE DATES: From: 06/09/1984 To: 09/10/1984
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: close-clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: enough to moisten 0.5 g of Nitroguanidine and form a thick paste
- Concentration of saline solution: 0.9%
- Lot/batch no.: 8C865AY - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour and 24, 48 and 72 h after treatment
- Number of animals:
- eight (four male and four female rabbits)
- Details on study design:
- TEST SITE
- Preparation of test site: backs were pre-clipped 4 days before dosing and then close-clipped 24 hours before actual dosing
- Area of exposure: back; the clipped area was devided into 4 qaudrants designated I, II, III, and IV
- Site I: vehicle control site
- Sites II and III: test compound sites
- Site IV: sham patch site
- % coverage:
- Type of wrap if used: gauze patch which was taped (semi-impervious hypo-allergenic surgical tape) to the appropriate site; Vet Wrap was then wrapped securely around the animal
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
- test substance was removed, the skin was wiped if the material adhered
SCORING SYSTEM: see table 1
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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30-60 min
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30-60 min after treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - no irritation/corrosion occured (see table 2)
- Other effects:
- Rabbit number 570 had multiple small (1 mm) pustules ventral to the patch area at 48 and 72 h after dosing. These lesions were positive for Staphylococcus aureus on bacteriological culture. The test area was not involved.
Any other information on results incl. tables
Table 2: Summary of Primary Irritation Test Data
|
30-60 min |
24 h |
48 h |
76 h |
||||||||
Animal No. |
Test |
Sham |
Vehicle |
Test |
Sham |
Vehicle |
Test |
Sham |
Vehicle |
Test |
Sham |
Vehicle |
570 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
571 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
572 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
573 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
574 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
575 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
577 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
578 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean* |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Net Mean Score t |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Nitroguanidine is not irritating under the conditions of this assay.
- Executive summary:
This study has been performed in compliance with Good Laboratory Practice (GLP). The study has been conducted according to US EPA Guideline 560/6-82-001, adopted August 1982.
A gauze patch with 0.5 g of test material (Nitroguanidine), moistened with 0.9% (w/v) physiol. saline, was placed on the clipped skin of four male and female New Zealand White rabbits and closely covered withgauze patch which was taped (semi-impervious hypo-allergenic surgical tape) to the appropriate site. Then Vet Wrap was wrapped securely around the animals. Total exposure duration was four hours. The control site was treated with physiol. saline only and covered analogically.
The animals were checked daily for mortality and systemic symptoms. Body weights were recorded four days prior to testing, at study initiation, and five and eight days after treatment. Skin reactions were evaluated 1, 24, 48, and 72 h after removing the patches according to the scoring system in table 1.
The test-compound was non-irritating. Neither erythema, edema, nor any other recognisable skin reactions were detected at 1, 24, 48 or 72 h after dosing or during the remaining period before terminal sacrifice 14 days after dosing.
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