Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-07-03 to 1984-08-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- publication
- Title:
- Ocular and Dermal Toxicity of Guanidine Nitrate
- Author:
- Korte DW et al
- Year:
- 1 993
- Bibliographic source:
- International Journal of Toxicology, Vol. 12, No. 6, 592-593
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Health effects test guidelines, August 1982, EPA 560/6-82-001
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- ; only 10 animals were used instead of 20, but as in all 10 animals clear negative results were obtained, this deviation is not considered relevant
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Study was conducted before the the Guideline for the LLNA-Test (OECD 429 and 442A/B) has been adopted.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA)
- Age at study initiation: 33 days
- Weight at study initiation: 178-225 g at 15 days prior to first induction dose
- Housing: individually in stainless steel, wire mesh cages
- Diet: ad libitum, Certified Purina Guinea Pig Chow Diet 5026 (Ralstone Purina Company, Checkerboard Square, St Louis, MO)
- Water: ad libitum, continuous drip from a central line
- Acclimation period: 15 days before adminisrtation of the first induction dose
ENVIRONMENTAL CONDITIONS
- Temperature: initially 18.9-22.2 °C, increased 22 days after arrival to 20.0-23.3 °C
- Humidity (%): 42-69 % with occasional peaks as high as 88 % during steam line adjustments and room washing
- Air changes (per hr): not specified
- Photoperiod: (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1984-07-03 To: 1984-08-27
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction: 10 % in isotonic saline
Challenge: 10 % in isotonic saline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction: 10 % in isotonic saline
Challenge: 10 % in isotonic saline
- No. of animals per dose:
- 4 - pilot dosing
10 main test treatment
10 main test positive control
10 main test negative control - Details on study design:
- PILOT STUDY FOR DOSE RANGE FINDING
4 animals; 100, 10, 1 and 0.1 % concentrations were used to assess the dermal irritation potential
Main study:
INDUCTION
topical application on the left flank
of 0.5ml of a 10 % solution/suspension in isotonic saline
under a 2.5 cm2 gauze patch for 6h;
three times at intervals of one week;
skin evaluation at 24 and 48h following patch removal
CHALLENGE
treatment and positive control animals: two doses on the left and rigth flank
negative control animals: one dose on the left flank
of 0.5ml of a 10 % solution/suspension in isotonic saline
under a 2.5 cm2 gauze patch for 6h;
one time 2 weeks after the last induction;
skin evaluation at 24 and 48h following patch removal
GRADING SYSTEM
Skin reactions were assigned scores according to the following grading system:
0 no reaction; 1 slight erythema; 2 moderate erythema; 3 marked erythema.
Results are expressed in terms of both incidence (the number of animals showing responses of 1 or greater at either 24 or 48h) and severity (the sum of the test scores divided by the number of animals tested). - Positive control substance(s):
- yes
- Remarks:
- 2,4 Dinitrochlorobenzene
Results and discussion
- Positive control results:
- DNCB produced a marked response after the first induction dose, i.e. after the second and third induction and after challenge. Among the positive control animals, the incidence of skin reactions was 9/9 after 24h and 7/9 after 48h. 1/10 animals was lost due to non-compound-related death. The severity of skin reactions was 1.33 after 24h and 1.11 after 48h. Only one response, a 0.5 borderline score, was observed 24h after challenge in one negative control animal. Conclusion: In this study, 24h after challenge treatment performed with 0.1% DNCB, 100% of the animals of the test group were observed with skin reactions.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 % in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 % in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 % in isotonic saline
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- one non-compound-related death
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 % in isotonic saline. No with. + reactions: 1.0. Total no. in groups: 9.0. Clinical observations: one non-compound-related death .
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 % in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- one non-compound-related death
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one non-compound-related death .
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- Skin reaction
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 7
- Total no. in group:
- 9
- Clinical observations:
- Skin reaction
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
PILOT STUDY AND DOSE RANGE FINDING
Concentration for induction and challenge:10%
SKIN EFFECTS IN INDUCTION
No skin reaction was observed after the first, second and third induction in the control and test animals treated with the test item at 10 % in isotonic saline.
SKIN EFFECTS IN CHALLENGE
A very slight skin reaction was observed in 1/9 negative control animals 24 h after challenge, no skin reaction observed in the test animals: Treatment at challenge was performed with the test item at 10 % in isotonic saline.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study the test substance Guanidine Nitrate is not a dermal sensitiser.
- Executive summary:
In a dermal sensitization study according to the Health effects test guidelines, August 1982, EPA 560/6-82-001 with Guanidine Nitrate (a.i. 99.99%) diluted in isotonic saline, male young adult Hartley guinea pigs (10 per group) were tested using the method of Buehler. The positive control material used in the test was 2,4 -Dinitrochlorobenzene (DNCB).
After dermal induction with 10 % solution of test substance, no skin reaction was observed. Challenge treatment was performed with the same concentration of 10 %. None of the animals of the test group showed any skin effects, whereas one animal of the control group showed a very slight skin reaction.
The sensitization rate at 24 h and at 48 h was 0 %.
The test article is considered to be a non-sensitizer in this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.