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EC number: 241-659-6 | CAS number: 17675-60-4
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute Oral Toxicity
A single oral dose of the test item to female rats at a dose of 2000 mg/kg bw associated with signs of toxicity and mortality. The signs of toxicity recovered within up to 1-day post-dose. After this time point no signs of toxicity were visible. Rats dosed at 300 mg/kg bw showed signs of toxicity but no mortality. The signs of toxicity recovered within up to 240 minutes post-dose.The median lethal dose observed over a period of 14 days is: LD50 cut-off (rat): 2000 mg/ kg bw According to Annex I of Regulation (EC) 1272/2008 guanylurea phosphate is proposed to be classified into Category 4.
Acute Dermal Toxicity
Under the conditions of the present study, a single dermal application of the test item to rats at a dose of 2000 mg/kg bw was associated with no mortality and no signs of toxicity or of irritation were evident. The dermal LD50 was determined to be > 2000 mg / kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-03-2017 to 24-08-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Section 4, No. 423, “Acute Oral Toxicity – Acute Toxic
Class Method” adopted 17 December 2001 - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Batch No.: 16VL8189
Expiry Date: 03 August 2017
Storage Conditions: room temperature, protected from light - Species:
- rat
- Strain:
- Wistar
- Remarks:
- WISTAR rats Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Prior to the administration a detailed clinical observation was made of all animals. Only healthy animals were used, and food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
Housing and Feeding Conditions:
Full barrier in an air-conditioned room
Temperature: 22 3 °C
Relative humidity: 55 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice
Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals).
The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw
fibre bedding - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Single oral dose at a dose volume of 10 mL/kg body weight.
- Doses:
- 2000 mg/kg body weight and 300 mg/kg body weight
- No. of animals per sex per dose:
- 3 per step, see results
- Control animals:
- no
- Details on study design:
- The starting dose was selected to be 2000 mg/kg body weight. Compound-related mortality was recorded for one animal of step 1. Based on these results and according to the acute toxic class method regime, a second step was performed at a dose of 2000 mg/kg body weight. Compoundrelated mortality was recorded for any animal of step 2. Based on these results and according to the acute toxic class method regime, a third step was performed at a dose of 300 mg/kg body weight. No compound-related mortality was recorded for any animal of step 3. Based on these results and according to the acute toxic class method regime, a fourth step was performed at a dose of 300 mg/kg body weight. No compound-related mortality was recorded for any animal of step 4. Based on these results and according to the acute toxic class method regime, no further testing was required.
The surviving animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
The animals which died spontaneously during the observation period were necropsied directly after onset of death. At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy. All gross pathological changes were recorded but not preserved for possible histopathological evaluation. - Statistics:
- Results were interpreted according to OECD Guideline 423, Annex 2
- Preliminary study:
- See any other information on results
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- LD50 cut-off (rat): 2000 mg/ kg bw
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item showed mortality and other acute oral toxicity characteristics after a single dose administration of 2000 mg/kg body weight. The test item showed no mortality but other acute oral
toxicity characteristics after a single dose administration of 300 mg/kg body weight. - Clinical signs:
- other: See any other information on results
- Gross pathology:
- See any other information on results
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 cut-off (rat): 2000 mg/ kg bw
- Executive summary:
A single oral application of the test item guanylurea phosphate to female rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity and mortality. The signs of toxicity recovered within up to 1-day post-dose. After this time point no signs of toxicity were visible. A single oral application of the test item guanylurea phosphate to female rats at a dose of 300 mg/kg body weight was associated with signs of toxicity but no mortality. The signs of toxicity recovered within up to 240 minutes post-dose. After this time point no signs of toxicity were visible.
The median lethal dose observed over a period of 14 days is: LD50 cut-off (rat): 2000 mg/ kg bw. According to Annex I of Regulation (EC) 1272/2008 guanylurea phosphate is proposed to be classified into Category 4.
Reference
Clinical Signs - Individual Data | ||||
Step | Female No. | Dose (mg/kg bw) | Timepoint | Observations |
1 | 1 | 2000 | 0-60 min | nsf |
60 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure, slight salivation | |||
240 -15 d | nsf | |||
2 | 2000 | 0 -120 min | nsf | |
120 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure, slight salivation | |||
240 - 300 min | Died spontaneously | |||
3 | 2000 | 0 -120 min | nsf | |
120 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure, slight salivation | |||
240 min -15 d | nsf | |||
2 | 4 | 2000 | 0-30 min | Moving the bedding, moderate salivation |
30 - 60 min | Moderately reduced spontaneous activity, moving the bedding, hunched posture, slow movements, slight piloerection, half eyelid closure, slight salivation | |||
60 -120 min | Moderately increased spontaneous activity, hunched posture, slight piloerection, half eyelid closure, slow movements | |||
120 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure | |||
240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, eyes closed, slow movements. Died spontaneously |
|||
5 | 2000 | 0-30 min | Moving the bedding, moderate salivation | |
30 - 60 min | Moving the bedding, moderately reduced spontaneous activity, hunched posture, slow movements, slight piloerection, half eyelid closure, slight salivation | |||
60 -120 min | Moderately reduced spontaneous activity, hunched posture, slow movements, slight piloerection, half eyelid closure | |||
120 -180 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure | |||
180 min | Died spontaneously | |||
6 | 2000 | 0-30 min | Moving the bedding, moderate salivation | |
30 - 60 min | Moving the bedding, moderately reduced spontaneous activity, hunched posture, slow movements, slight piloerection, half eyelid closure, slight salivation | |||
60 -120 min | Moderately reduced spontaneous activity, hunched posture, slow movements, slight piloerection, half eyelid closure | |||
120 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure | |||
240 min | Moderately reduced spontaneous activity, hunched posture, slow movements, moderate piloerection, eyes closed. Died spontaneously |
|||
3 | 7 | 300 | 0-30 min | nsf |
30 - 60 min | Moderately reduced spontaneous activity, prone position, half eyelid closure | |||
60 -120 min | Slightly reduced spontaneous activity, half eyelid closure, slight salivation | |||
120 -180 min | Slightly reduced spontaneous activity, half eyelid closure, moderate piloerection | |||
180 - 240 min | Slightly reduced spontaneous activity, | |||
240 min - 15d | nsf | |||
8 | 300 | 0-30 min | nsf | |
30 - 60 min | Moderately reduced spontaneous activity, prone position, half eyelid closure | |||
60 -120 min | Slightly reduced spontaneous activity, half eyelid closure | |||
120 -180 min | Slightly reduced spontaneous activity, half eyelid closure, moderate piloerection | |||
180 - 240 min | Slightly reduced spontaneous activity | |||
240 min- 15d | nsf | |||
9 | 300 | 0-30 min | nsf | |
30 - 60 min | Moderately reduced spontaneous activity, prone position, half eyelid closure | |||
60 -120 min | Slightly reduced spontaneous activity, half eyelid closure | |||
120 -180 min | Slightly reduced spontaneous activity, half eyelid closure, moderate piloerection | |||
180 - 240 min | Slightly reduced spontaneous activity | |||
240 min-15 d | nsf | |||
4 | 10 | 300 | 0 min - 15 d | nsf |
11 | 300 | 0 min - 15 d | nsf | |
12 | 300 | 0 min - 15 d | nsf | |
d = day; min = minute(s); nsf = no specific findings |
Body Weights (g) & Body Weight Gain % | ||||||
Step | Female No. | Dose (mg/kg bw) | BW (g) | Body weight in comparison to day 1 (%) | ||
Day 1 | Day 8 | Day 15 | 15 | |||
1 | 1 | 2000 | 146 | 166 | 175 | 20 |
2 | 2000 | 146 | Died spontaneously | |||
3 | 2000 | 150 | 165 | 174 | 16 | |
2 | 4 | 2000 | 159 | Died spontaneously | ||
5 | 2000 | 162 | ||||
6 | 2000 | 158 | ||||
3 | 7 | 300 | 140 | 172 | 184 | 31 |
8 | 300 | 140 | 170 | 199 | 42 | |
9 | 300 | 130 | 162 | 182 | 40 | |
4 | 10 | 300 | 142 | 173 | 191 | 35 |
11 | 300 | 140 | 170 | 183 | 31 | |
12 | 300 | 149 | 176 | 174 | 17 | |
Day 1 = day of administration; bw = body weight |
Findings at Necropsy - Individual Data | ||||
Step | Female No. | Starting Dose (mg/kg bw) | Organ | Macroscopic Findings |
1 | 1 | 2000 | - | nsf |
2 | stomach | Test item residues | ||
3 | - | nsf | ||
2 | 4 | stomach | Test item residues | |
5 | ||||
6 | ||||
3 | 7 | 300 | - | nsf |
8 | - | nsf | ||
9 | - | nsf | ||
4 | 10 | - | nsf | |
11 | - | nsf | ||
12 | - | nsf | ||
bw = body weight; nsf = no specific findings |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliability 1
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20-03-2017 to 29-06-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Section 4, No. 402, “Acute Dermal Toxicity” adopted 24 Feb, 1987
- Deviations:
- yes
- Remarks:
- For technical reasons all raw data were recorded on paper.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- Batch No.: 16VL8189
Expiry Date: 03 August 2017
Storage Conditions: room temperature, protected from light - Species:
- rat
- Strain:
- Wistar
- Remarks:
- WISTAR Crl: WI(Han) rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age at the beginning of the study: males: 9-10 weeks old; females: 9-10 weeks old
Body weight on the day of administration: males: 265 – 289 g females: 200 – 215 g
Housing and Feeding Conditions:
Full barrier in an air-conditioned room
Temperature: 22 3 °C
Relative humidity: 55 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice
Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water,
municipal residue control, microbiological controls at regular intervals)
The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw
fibre bedding
Adequate acclimatisation period (at least five days) under laboratory conditions
Preparation of the Animals:
The animals were marked for individual identification by tail painting.
Approximately 25 (for males) and 24 (for females) hours before the test, the fur was removed from
the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and
only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application.
Prior to the application a detailed clinical observation was made of all animals. Only healthy animals
were used. - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- Approximately 25 (for males) and 24 (for females) hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application.
Prior to the application a detailed clinical observation was made of all animals. Only healthy animals were used. - Duration of exposure:
- 24 hours
- Doses:
- Single dose of 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- OECD 402: All animals were observed for 14 days after dosing.
- Statistics:
- Signs of erythema and oedema were assessed using the scoring system (Table 2) laid down in OECD Guideline 404
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No test substance related deaths
- Clinical signs:
- other: No signs of toxicity for both sexes. No skin irritation for both sexes.
- Gross pathology:
- No significant findings.
- Conclusions:
- The dermal LD50was determined to be > 2000 mg GUANYLUREA PHOSPHATE / kg body weight.
- Executive summary:
Under the conditions of the present study, single dermal application of the test item GUANYLUREA PHOSPHATE to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation. The dermal LD50 was determined to be > 2000 mg GUANYLUREA PHOSPHATE / kg body weight.
Reference
Absolute Body Weights in g and Body Weight Change in %
Dose: 2000 mg/kg body weight |
||||
Animal No. / Sex |
g Day 1 |
g Day 8 |
g Day 15 |
% Day 1-15 |
21 / male |
265 |
281 |
304 |
15 |
22 / male |
273 |
291 |
317 |
16 |
23 / male |
273 |
299 |
326 |
19 |
24 / male |
289 |
307 |
350 |
21 |
25 / male |
271 |
289 |
322 |
19 |
26 / female |
206 |
211 |
217 |
5 |
27 / female |
201 |
205 |
210 |
4 |
28 / female |
205 |
203 |
224 |
9 |
29 / female |
215 |
219 |
233 |
8 |
30 / female |
200 |
210 |
214 |
7 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliability 1
Additional information
Justification for classification or non-classification
Acute Oral Toxicity
According to Annex I of Regulation (EC) 1272/2008 guanylurea phosphate is proposed to be classified into Category 4.
Acute Dermal Toxicity
According to Annex I of Regulation (EC) 1272/2008 guanylurea phosphate no classification is proposed.
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.
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