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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1984 - January 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:
- no
- Remarks:
- slit lamp exam. was added; colour photographic docum. was not performed; 8-hour period with altered temperatur and humidity range; diet was fed at 150 g/d and not ad libitum > none of these dev. had a negative impact on study performance and validity
- GLP compliance:
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elkhorn Rabbitry, 5265 Starr Way, Watsonville, CA, U.S.A.)
- Age at study initiation: young adults
- Sex: males
- Weight at study initiation: 2.4-3.5 kg
- Housing: individually in stainless steel, screen-bottomed, battery-type cages with automatically flushing dump tanks
- Diet: approx. 150 g/day of Certified Purina Chow Diet 5322 (Ralston Purina Company)
- Water: continous drip from a central line
- Pretest conditioning: 1. quarantine from 6 Sept- 19 Sept 1984
2. animal eyes were examined 24 hours before dosing using slit lamp, fluorescein dye and ultraviolet light
- Acclimation period: at least five days after quarantine
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14.4-17.8; exception: 8-hour period on 22 Sep 84 when the temperature fluctuated between 12.8 and 26.7 °C
- Humidity (%): 40-70%
- Photoperiod (hrs dark/hrs light): 12/12
IN-LIFE DATES:
Group1 > From: 25 Sep 1984 To: 28 Sep 1984
Group2 > From: 2 Oct 1984 To: 5 Oct 1984
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.025 g (=0.1 ml)
- Administration: the lower lid was pulled away from the conjunctival cul-de-sac to form a cup into which the compound was dropped. Upper and lower lids were then held gently together for one second to prevent loss of material. - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three animals per dose group (two dose groups).
Group one was dosed on 25 Sep 84 and group 2 was dosed on 2 Oct 84. - Details on study design:
- TEST PROCEDURE:
- prior to study initiation animals were examined for any pre-existing abnormalities.
- For each animal, the eye with the nearest normal appearance was designated for treatment; the contralateral eye served as control.
- On the next day, 0.025 g Nitroguanidine was placed in the treated eye of each rabbit in this group (group 1: 25 Sep 1984; group 2: 2 Oct 1984)
SCORING SYSTEM: Draize-type ocular grading
TOOL USED TO ASSESS SCORE:
- slit lamp (24, 48, and 72-hour-observations); additionally any areas appearing grossly abnormal were examined under high magnification
- fluorescein: introduced onto the eye which was then observed under unltraviolet light. Any corneal areas reacting with the dye (a sign of discontinuity of the corneal epithelium) were described with respect to area and intensity of fluorescence
- Examination and grading of ocular reactions were performed in this fashion at 1, 4, 24, 48, and 72 h after dosing.
- Fluorescein staining was omitted from the 1 and 4 hour-observations, as was slit lamp examination.
- Due to an almost lack of reaction during the 72 hours after dosing, the study was terminated, according to protocol, after this observation. Therfore no scoring or observations were performed at 7, 14, or 21 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity 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:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 and 4 h after dosing
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 and 4 h after dosing
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 and 4 h after dosing
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: slight conjunctival injection
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- conjunctival swelling
- 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:
- chemosis score
- Remarks:
- conjunctival swelling
- Basis:
- mean
- Time point:
- other: 1 and 4 h after dosing
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Control Eyes:
- At no time during the study did no contralateral, untreated eyes exhibit any changes from the pre-dosing examination.
- Fine diffuse stippling was present before and after dosing in the control eye of one rabbit.
- All other untreated controls were normal throughout the entire study.
Nitroguanidine produced no positive reactions. Slight conjunctival redness, indicating mild inflammation, was the only response observed. This reaction, although scorable, did not achieve sufficient severity to warrant consideration as a “positive response”. A likely explanation for this slight redness was the observed presence in the lower conjunctival cul-de-sac (the site of gradable redness) of small amounts of the test material. Most of the eyes with gradable redness exhibited undissolved nitroguanidine. Therefore physical irritation, not pharmacological activity, may have been responsible for the slight response observed. Since human exposure would be closely followed with thorough washing, even this slight response may not occur.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study, nitroguanidine produced no response indicative of a potential to cause occular irritation upon direct contact with the eye.
- Executive summary:
In an acute eye irritation study using a modified Draize method (US EPA 560/6-82-001), 0.1 ml (corresponding to 0.025 g) of Nitroguanidine was instilled into the conjunctival sac of the eye of six male albino rabbits (New Zealand White strain). Eyes were not washed afterwards. Animals then were observed for 3 days. Irritation was scored by the method of US EPA 560/6-82-001.
Under the experimental conditions employed, Nitroguanidine produced no positive reactions. Slight conjunctival redness, indicating mild inflammation, was the only response observed. This reaction, although scorable, did not achieve sufficient severity to warrant consideration as a “positive response”. A likely explanation for this slight redness was the observed presence in the lower conjunctival cul-de-sac (the site of gradable redness) of small amounts of the test material. Most of the eyes with gradable redness exhibited undissolved nitro guanidine. Therefore physical irritation, not pharmacological activity, may have been responsible for the slight response observed. Since human exposure would be closely followed with thorough washing, even this slight response may not occur.
In the present study, nitroguanidine produced no response indicative of a potential to cause occular irritation upon direct contact with the eye.
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