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EC number: 246-107-8 | CAS number: 24245-27-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline for 28-day repeated dose toxicity in mammalian species (Chemical Substances Control Law of Japan)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,3-diphenylguanidine
- EC Number:
- 203-002-1
- EC Name:
- 1,3-diphenylguanidine
- Cas Number:
- 102-06-7
- Molecular formula:
- C13H13N3
- IUPAC Name:
- 1,3-diphenylguanidine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River jpan Co. (Yokohama, Kanagawa Prefecture)
- Age at study initiation: 5 weeks of age
- Weight at study initiation: males=129-139g, females=103-119g
- Fasting period before study: no data
- Housing: individually in cages with aluminium faces
- Diet: NIH open formula rat and mouse ration manufactured by Oriental Yeast Co. Ltd, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13+/-3
- Humidity (%): 55+/-20
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12/12 (lighted at 7 am)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days 4 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 90 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes, 1 and 5 hours after administration, 3 times a daily during the administration period, and 2 times a day during the recovery period (morning and afternoon).
DETAILED CLINICAL OBSERVATIONS: Yes, on all living of the animals scheduled for necropsy at the end of the administration period and at the end of the recovery period.
BODY WEIGHT: Yes, weekly from the beginning of administration to the end of the recovery period.
FOOD CONSUMPTION & FOOD EFFICIENCY: Yes, weekly
WATER CONSUMPTION : No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on all living of the animals scheduled for necropsy at the end of the administration period and at the end of the recovery period.
- Anaesthetic used for blood collection: Yes with ether
- Animals fasted: Yes, 16 hours for blood sampling
- How many animals: 5/sex or all survivors
- Parameters examined : hematocrit, hemoglobin, red blood cells, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobine concentration, platelets, white blood cells, white blood cell percentage + blood coagulation examination
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on all living of the animals scheduled for necropsy at the end of the administration period and at the end of the recovery period.
- Animals fasted: Yes, 16 hours for blood sampling
- How many animals: 5/sex or all survivors
- Parameters examined : total protein, albumin, A/G, glucose, neutral fats, total cholesterol, blood urea nitrogen, creatinine, T.bilirubin, aspartate aminotransferase, alanine transaminase, alkaline phosphatase, calcium, inorganic phosphorus, sodium, potassium, chloride.
URINALYSIS: Yes
- Time schedule for collection of urine: for 3 hr (10am to 1pm) and 24 hr (10 am to 10 am on the following day)
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- How many animals: 5/sex or all survivors
- Parameters examined (3 hr) : pH, accult blood, ketone bodies, glucose, protein, bilirubin, urobilinogen.
- Parameters examined (24 hr) : urine volume, color, urine specifique gravity, urine sediments.
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER: Organ weights - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
ORGAN WEIGHTS: brain, lungs, liver, kidney, adrenals, thymus, heart, spleen, testes, epididymis and ovaries
HISTOPATHOLOGY: Yes
Thymus, heart, lungs (including trachea), larynx, liver, spleen, kidney, adrenals, stomach, testes, epididymis, uterus, ovaries, bone marrow (femur), brain (including the brain stem), spinal cord, sciatic nerve and target organs - Other examinations:
- no
- Statistics:
- The body weights, food consumption, food efficiency, hematological examination values, blood coagulation examination values, blood chemical examination values, urine examination values (urine volume and specific gravity), organ weights and organ weight/body weight ratio were subject to Bartlett’s distribution testing. Equal distribution was determined using the significant differences between the control groups and each of the administration groups according to Dunnett’s multiple comparison test. Inequal distribution was determined using the significant differences between the control groups and each of the administration groups according to Bartlett’s distribution test. For inequal distributions using Bartlett’s distribution test, the significant differences between the control groups and each of the administration groups were determined according to Steel’s test.
The significant standards for the quantitative values were conducted using 5 and 1% single assays.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: significantly high values for platelet counts in females as well as significantly low values for blood glucose in males in the 30 mg/kg group
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1 : Hematology of rats treated orally with 1,3-diphenylguanidine in the twenty-eight-day repeated dose toxicity test
28 -day dosing groups (mg/kg) |
14 -day recovery groups (mg/kg) |
|||||
Item |
0 |
10 |
30 |
90 |
0 |
90 |
MALE |
||||||
No. ofanimals |
5 |
5 |
5 |
5 |
5 |
4 |
HCT(%) |
46.2± 2.6N |
45.4±0.4 |
45.6±0.7 |
46.4±1.7 |
47.0±1.7 |
45.5±2.1 |
HGB(g/dL) |
14.9±0.7 |
14.7±0.3 |
15.1±0.2 |
15.4±0.5 |
15.9±0.4 |
15.4±0.5 |
RBC(X10^6/mm3) |
7.56 ±0.51 |
7.50±0.27 |
7.62±0.24 |
7.91±0.27 |
8.29±0.43 |
7.91±0,32 |
MCV (µm3) |
61,1±1.1 |
60.6±2.1 |
59.9±1.4 |
58.7±1.7* |
56.7±1.7 |
57.4±0.7 |
MCH (pg) |
19,7±0.6 |
19.7±0.7 |
19.8±0.6 |
19.5±0.5 |
19.2±0.7 |
19.5±0.4 |
MCHC(%) |
32.3±0.5 |
32.5±0.6 |
33.1±0.4* |
33.2±0.5* |
33.8±0.4 |
33.9±0.6 |
PLT(x10^3/mm3) |
1188±111 |
1118±78 |
1153±86 |
1118±76 |
1121±59 |
1217±109 |
WBC(x10^3/mm3) |
13.7±1.9 |
11.0±2.5 |
13.2±3.6 |
11.8±2.8 |
13.8±4.3 |
12.4±3.0 |
Differential leukocyte Counts (%) |
||||||
NEUT |
9±4 |
11±3 |
11±4 |
13±5 |
10±3 |
11±2 |
LYMPH |
88±4 |
85±3 |
86±4 |
83±5 |
85±3 |
85±2 |
MONO |
1±1 |
2±1 |
1±1 |
2±1 |
2±0 |
2±1 |
EOSN |
1±1 |
1±0 |
1±1 |
1±0 |
1±0 |
1±1 |
BASO |
0±0 |
0±0 |
0±0 |
0±0 |
0±0 |
0±1 |
LUC |
1±0 |
1±0 |
1±0 |
1±0 |
1±0 |
1±0 |
FT (sec.) |
14.2±0.5 |
14.2±0.6 |
14.7±0.8 |
14.5±0.5 |
14.8±0.8 |
14.1±0.5 |
APTT(sec.) |
25.5±1.6 |
26.4±0.8 |
25.8±16 |
25.0±1.6 |
27.6±1.6 |
25.7±1.9 |
Fibrinogen (mg/dL) |
212±12 |
222±7 |
214±8 |
209±24 |
229±16 |
222±17 |
FEMALE |
||||||
No.ofanimals |
5 |
5 |
5 |
1 |
5 |
2 |
HCT(%) |
44.4±1.4 |
44.0±2.3 |
43.5±1.4 |
49.39 |
43.4±1.6 |
41.9±5.4 |
HGB(g/dL) |
15.0±0.6 |
14.8±0.5 |
14.6±0.4 |
16.7 |
15.4±0.5 |
14.8±1.5 |
RBC(X10^6/mm3) |
7.62±0.20 |
7.59±0.53 |
7.55±0.25 |
8.30 |
7.91±0.22 |
7.51±0.91 |
MCV (µm3) |
58.3±2.1 |
58.1±1.4 |
57.7±2.0 |
59.4 |
54.8±0.9 |
558±0.4 |
MCH (pg) |
19.7±0.8 |
19.6±0.8 |
19.4±0.5 |
20.2 |
19.4±0.5 |
19.7±0.4 |
MCHC(%) |
33.8±0.5 |
33,6±0.7 |
33.6±0.6 |
33.9 |
35.5±0.6 |
35.2±1.0 |
PLT(x10^3/mm3) |
1213±83 |
1308±57 |
1436±117** |
1412 |
1158±122 |
1114±192 |
WBC(x10^3/mm3) |
7.3±2.1 |
7.3±1.0 |
6.1±2.0 |
7.5 |
6.7±1.9 |
5.6±2.2 |
Differential leukocyte Counts (%) |
|
|||||
NEUT |
12±5 |
12±7 |
12±5 |
41 |
10±3 |
14±4 |
LYMPH |
85±5 |
84±6 |
85±5 |
50 |
86±2 |
83±4 |
MONO |
1±1 |
2±1 |
2±1 |
7 |
2±0 |
1±0 |
EOSN |
1±0 |
2±1 |
1±1 |
0 |
1±0 |
1±0 |
BASO |
0±0 |
0±0 |
0±0 |
0 |
0±0 |
0±0 |
LUC |
1±1 |
1±0 |
1±1 |
3 |
1±0 |
1±0 |
FT (sec.) |
14.8±0.6 |
15.0±0.34 |
15.0±0.3 |
13.8 |
14.9±0.4 |
15.1±1.3 |
APTT(sec.) |
23.0±0.8 |
21.8±1.2 |
22.2±0.9 |
25.0 |
22.2±1.5 |
23.5±3.6 |
Fibrinogen (mg/dL) |
194±10 |
191±20 |
183±11 |
285 |
176±15 |
179±18 |
NEUT : Neutrophil, LYMPH : Lymphocyte,MONO:Monocyte,EOSN: Eosinophil, BASO: Basophil,LUC:Large unstained cells. Valuesareexpressedas Mean±S.D. Significantdifferencefrom control group; *p<0.05, ** p<0.01 N:Nonparametric analysis |
Table 2 : Blood chemistry of rats treated orally with 1,3-diphenylguanidine in the twenty-eight-day repeated dose toxicity test
28 -day dosinggroups (mg/kg) |
14-dayrecovery groups (mg/kg) |
|||||
Item |
0 |
10 |
30 |
93 |
0 |
90 |
MALES |
||||||
No.ofanimals |
5 |
5 |
5 |
5 |
5 |
4 |
Glucose (mg/dL) |
157±7 |
156±12 |
136±19* |
119±12** |
152±16 |
135± 5* |
T.cholesterol (mg/dL) |
55±9 |
59 ± 15 |
55±11 |
66±20 |
63±8 |
55± 17 |
Triglycéride(mg/dL) |
38.2±21.1 |
46.4±23.1 |
41.3±14.2 |
21.5± 6.8 |
50.4±6.2N |
37.0± 28.3 |
BUN(mg/dL) |
10.5±1.3 |
10.0±1.3 |
11.2±1.5 |
13.7±1.2** |
13.5±1.1 |
13.5±1.3 |
Creatinine (mg/dL) |
0.21±0.03 |
0.22±0.02 |
0.21±.0.03 |
0.21±0.02 |
0.22±0.02 |
0.23±0.06 |
T.bilirubin(mg/dL) |
0.03±0.01 |
0.03±0.01 |
0.03±0.01 |
0.06±0,01** |
0.04±0.01 |
0.04±0.01 |
T.protein(g/dL) |
5.66±0.21 |
5.75±0.12 |
5.46±0.20 |
5.55±0.20 |
5.82±0.18 |
5.59±0.18* |
Albumin(g/dL) |
3.42±0.15 |
3.38±0.11 |
3.37±0.14 |
3.55±0.11 |
3.36±0.16 |
3.29±0.14 |
A/G |
1.53±0.10 |
1.42±0.08 |
1.61±`0.11 |
1.80±0.21** |
1.36±0.07 |
1.44.±0.08 |
AST(U/L) |
70±7 |
64±6 |
69±10 |
68±8 |
68±5 |
87±10** |
ALT (UIL) |
24±4 |
23±4 |
26±4 |
39± 6** |
27±3 |
29±2 |
ALP(U/LI |
784 ±116 |
781±176 |
929±208 |
1156±308* |
608±97 |
617±140 |
FEMALES |
||||||
No. ofanimals |
5 |
5 |
5 |
1 |
5 |
2 |
Glucose(mg/dL) |
126±15 |
126±9 |
116±11 |
107 |
132±2N |
131±21 |
T.cholesteroi(mg/dL) |
54±10 |
59±15 |
72 ±5* |
73 |
65±9 |
59±4 |
Triglyceride(mg/dL) |
13.1±6.9 |
21.4± 9.5 |
27.6±12.9* |
15.8 |
30.2± 20.4N |
11.4±0.7 |
BUN(mg/dL) |
15.3±3.6 |
14.7±1.8 |
14.2±2.7 |
12.5 |
15.8±2.2 |
16.1±2.9 |
Créatinine (mg/dL) |
028±0.06 |
0.27±0.02 |
0.26±0.03 |
0.21 |
0.31±0.03 |
0.31±0.03 |
T.bilirubin(mg/dL) |
0.03±0.01 |
0.04±0.01 |
0.03±0.01 |
0.01 |
0.06±0.02 |
0.08±0.01 |
T.protein(g/dL) |
5.87±0.12 |
5.67±0.12* |
5.78± 0.15 |
6.70 |
5.85±0.18 |
5.81±0.08 |
Aibumin(g/dL) |
3.62±0.16 |
3.48±0.16 |
3.58± 0.10 |
4.03 |
3.61±0.17N |
3.60 ± 0.01 |
A/G |
1.61±0.14 |
1.59±0.15 |
1.63±0.06 |
1.51 |
1.62 ±0.10 |
1.63±0.05 |
AST(WL) |
70±10 |
70±8 |
80±7 |
80 |
72±10 |
88±8 |
ALT(LT/L) |
19±3 |
21±3 |
24±3* |
28 |
26±3 N |
36±16 |
ALP(U/L) |
466 ±40 |
488±98 |
424±37 |
521 |
328± 58 |
312±78 |
Values are expressed asMean ± S.E. Significantdifferencefrom controlgroup : *p<0.05 ; **p<0.01 N:Non parametric analysis |
Applicant's summary and conclusion
- Conclusions:
- The NOEL for repeat dose toxicity is considered to be 10 mg/kg/day for both sexes.
- Executive summary:
The repeated dose toxicity of DPG in corn oil was evaluated atdaily dose levels of 0, 10, 30 and 90 mg/kg in a 28-day oral repeated dose toxicity study in Crj:CD(SD) rats performed following the OECD guideline 407 and GLP. Five each of males and females were assigned to each group, and recovery groups were formed with five each of males and females, assigned to the control group and the maximum dose group. Clinical signs, body weight, food consumption, hematology, blood coagulation, blood chemistry, urinalysis, organ weights and histological examinations were conducted.
Dead or moribund animals were observed in both sexes in the 90 mg/kg group during the administration period.One male died during week 4, and 7 females died or were moribund during weeks 2~4, so the mortality rate was 10% for males and 70% for females. The results of the pathological examination did not exhibit any changes correlating to the cause of death. During observations on the general conditions, salivation was observed in both sexes in the 30 mg/kg Clinical symptoms including salivation, lying prone on the stomach, lying laterally, staggered gait, reduction in spontaneous motor activity and startle response were observed in both sexes in the 90 mg/kg group. Furthermore, in the dead or moribund females in the 90 mg/kg group, emaciation, fur loss on the rear limbs and dirty fur were observed. The symptoms observed during the administration period were not observed during the recovery period, and indicates reversibility. During the administration period, significantly low values or a tendency of low values was noted for body weight and food consumption in both sexes in the 90 mg/kg group. Also, significantly low values or a tendency of low values was noted for weight gain and total food consumption during the 4thweek of administration. In males, significantly low values were observed for the mean food efficiency at the 4thweek of administration. Reversibility from these changes was noted during the recovery period.The results of the hematological examination revealed no impact of the administration of the test substance on males.In females, significantly high values were noted for platelet counts in the 30 mg/kg group. There was one survivor in the 90 mg/kg group where a trend of high values was noted for hematocrit values, hemoglobin, red blood cell count, platelet count, neutrophil ratio, monocyte ratio and large unstained cell ratio, and a trend of low values was noted for lymphocyte ratio.At the end of the recovery period, neither sex exhibited any significant differences between the control group and the test substance group. The results of the blood coagulation examinations revealed one surviving case where a trend of high values were noted for fibrinogen by the end of administration in females in the 90 mg/kg group, but if this was excluded, differences were not noted between the control group and the test substance group for both sexes. Blood chemistry examination revealed significantly low values in blood glucose in males in the 30 and 90 mg/kg groups, and significantly high values in blood urea nitrogen, total bilirubin, A/G ratio, ALT and alkaline phosphatase in males in the 90 mg/kg group. A tendency for high values in total cholesterol, total protein, albumin, sodium, chloride, calcium, inorganic phosphorus and ALT was noted in one survivor by the end of administration in females in the 90 mg/kg group. At the end of the recovery period, slightly low values were noted in the males in the 90 mg/kg group. Urinalysis revealed an increase in urine volume and a decrease in specific gravity in both sexes in the 90 mg/kg group. Furthermore, there was an increase in ketone bodies and negative protein. At the end of the recovery period, significantly low values were noted in specific gravity in males in the 90 mg/kg group. Results of the organ weight measurements did not indicate differences that suggest a clear impact of administration of the test substance. Histopathological examination results and necropsy findings revealed emaciation in the moribund and dead animals. Additionally, while the toxicological significance is not clear, the liver turned brown in males in the 30 mg/kg group and in both sexes in the 90 mg/kg group, while the eardrums were observed to turn red in both sexes in the 90 mg/kg group. Pathological examinations revealed hydropic changes in renal collecting tubules in both sexes in the 90 mg/kg group. In the dead and moribund animals, there was a higher rate of incomplete uterus findings. However, there were only a few cases but atrophied or nuclear decay of the thymus, hydropic or hemorrhagic lung, liver congestion or necrosis, or dilation of the kidney was also noted. Furthermore, while the toxicological significance is not clear, a reduction in the fatty change in the liver was noted in males in the 30 and 90 mg/kg groups.
From the results given above, since salivation was noted in both sexes and there were significantly high values for platelet counts in females as well as significantly low values for blood glucose in males in the 30 mg/kg group, the NOEL is considered to be 10 mg/kg/day for both sexes.
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