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Diss Factsheets
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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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 Sep - 10 Oct 1984
- 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:
- other: EPA Office of Pesticides and Toxic Substances (Ts-792); Acute exposure, dermal toxicity. In: Health Effects test guidelines. Washington DC; 1982; EPA 560/6-82-001
- Deviations:
- yes
- Remarks:
- The animals were not submitted to necropsy until 15 days after dosing. Animals were observed on the 15th day before being submitted for necropsy. The food for the animals was removed early on the 14th day and was returned later that morning after the next
- Principles of method if other than guideline:
- according to: Acute dermal toxicity study. LAIR Standard Operation Procedure OP-STX-30, Letterman Army Institute of REsearch, Presidio of San Francisco. 1984
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP study number 84025
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elkhorn Rabbitry, Watsonville, CA 95076
- Age at study initiation: young
- Weight at study initiation: 2539 - 3900 g
- Housing: individually in stainless steel, wire mosh bottom, battery-type cages with automatic flushing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 19 days (quarantained)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20 C°
- Humidity (%): 50-70 % (spikes up to 85% during room cleaning)
- Photoperiod (hrs dark/hrs light): 12 h/12h
IN-LIFE DATES: From: 25. Sept 84 To: 10. Oct 84
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 300 cm^2
- Type of wrap if used: gauze + hypoallergic tape (Durapore Surgical tape, 3M Corp) + Vetrap bandaging tape (Animal Care products, 3M Corp)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with gauze moistured with water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg
- Concentration (if solution): 0.25 g per ml salino
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 4 h after dosing and daily for the remainder of the study. A second "walk adjathrough" was performed daily with only significant observations recorded. Dermal observations also were recorded daily according to severity, area, and location.
- Necropsy of survivors performed: yes - Statistics:
- not applicable
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- Female:
84F584 - "[..] lymph nodes were greatly enlarged (up to 9 cm diameter), white and lobular. The nodes contained [..] white creamy material."
84F585 - no lesions recognized.
84F586 - no lesions recognized.
84F587 - no lesions recognized.
84F588 - The skin had a small (2 x 8 cm) area of slight erythema in the midlumber area.
Male:
84F591 - The skin had a small (2 x 3 cm) area of slight erythema in the midlumber area.
84F592 - There was a purulent, bilateral otitis media.
84F593 - The skin had a small (5 x 7 cm) area of slight erythema in the midline, dorsal thoracic area. The kidneys had bilateral tan mottled areas over the entire cortex.
84F594 - no lesions recognized.
84F595 - There was a purulent, bilateral otitis media.
Any other information on results incl. tables
- Both dosed and control skin section contain minimal, small aggregates of macrophages, heterophils and lymphocytes in the superficial dermis and adjacent to hair follicles. Dosed and control skin sections have a few follicles with individual or small groups (3 -6 cells) of necrotic cells in the external root sheath. There was no difference in severity of skin lesions between dosed and control skin sections.
- No compound related lesions and/or deaths were seen. Otitis media was considered an incidential finding.
- Tan, mottled, bilateral areas over the cortex of the kidney may have been caused by Encephalitozoon cuniculi, a commonprotozoen parasite of rabbit kidney.
- The erythema observed grossly in rabbits 84F588, 84F591 and 84F593 could not be directed microscopically and most likely was discoloration on the skin surface rather than erythema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A limit dose of 2 g/kg of nitroguanidine was not lethal following dermal exposure for 24 hours, and produced no compound-related clinical signs or dermal irritation during the 15 day observation period. Nitroguanidine possesses a minimal potential for acute dermal toxicity.
- Executive summary:
In an acute dermal toxicity study according to GLP, groups of New Zealand White Rabbits (5/male, 5/female) were dermally exposed to nitroguanidine (99.4 %) in physiol. saline for 24 h to approximately 300 cm2 at a LIMIT dose of 2 mg/kg bw. Animals then were observed for 15 days.
There were no treatment related deaths, clinical signs or necropsy findings. Nitroguanidine possesses a minimal potential for acute dermal toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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