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EC number: 483-980-6 | CAS number: -
- 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:
- End on 11 JULY 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Vegeflux soy
- Substance type: UVCB
- Physical state: viscous liquid
- Stability under test conditions: data not available
- Storage condition of test material: at room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal House, SGS Life Science Services
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 216 to 272 g (day 0)
- Fasting period before study: data not available
- Housing: animals were housed group wise (5 animals/sex/cage) in standard polypropylene cages with stainless steel top grill
- Diet: rat pellet feed (Amrut brand), ad libitum
- Water: potable water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19.9 - 23.1 °C
- Humidity: 59 - 69%
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): data not available
IN-LIFE DATES: from 03 APRIL 2008 to 30 MAY 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% methyl cellulose
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: the test item was prepared afresh daily with 0.5% methyl cellulose
VEHICLE
- Justification for use and choice of vehicle (if other than water): data not available
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): 10 mL/kg body weight - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily, 7 days each week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 150, 450, 1000 mg/kg bw
Basis:
other: nominal
- No. of animals per sex per dose:
- 5 animals/sex/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on a pilot study at 1000 and 1500 mg/kg bw for 7 days
- Rationale for animal assignment: animals were assigned to the different groups using a randomization procedure
- Post-exposure recovery period in satellite groups: 14 days in 2 satellite groups (0 and 1000 mg/kg, 10 animals/group) - Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: animals were observed daily
BODY WEIGHT: Yes
- Time schedule for examinations: body weight was recorded prior to treatment and at weekly interval thereafter
FOOD CONSUMPTION: calculated at weekly interval throughout the study
FOOD EFFICIENCY: not determined
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: prior to the first treatment and prior to sacrifice (using ophtalmoscope)
- Dose groups that were examined: all animals
HAEMATOLOGY: Yes
- Time schedule for collection of blood: blood samples were collected at the end of dosing or post-treatment observation period
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all animals
- Parameters checked in table 1 were examined: haemoglobin, RBC, WBC (total and differential), haematocrit (HCT), platelet count, MCH, MCHC, MCV and clotting time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of dosing and post-treatment observation period
- Animals fasted: Yes
- How many animals: all animals
- Parameters checked in table 1 were examined: glucose (fasted), urea, creatinine, total protein, albumin, total bilirubin, Alanine aminotransferase, Aspartate aminotransferase, sodium, cholesterol and potassium
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: during the 4th week of dosing or during the 2nd week of post-treatment observation period
- Dose groups that were examined:all animals
- Battery of functions tested: sensory reactivity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 2)
HISTOPATHOLOGY: Yes (see table 2) - Statistics:
- the change in body weight, feed consumption, haematology, clinical chemistry, and organ weights of animals belonging to the treatment groups were compared to the control group by statistical analysis using Student's 't'-test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- - CLINICAL SIGNS AND MORTALITY: No mortality occurred in any of the treatment and control group. However loose stools were observed after test item administration in all groups of treated and control animals that persisted up to 5th day of observation period. The sign exhibited by the animals could not be related to test item administration and it may be due to the vehicle used.
BODY WEIGHT AND WEIGHT GAIN: statistically significant changes were observed on second and thirD week of 1000 mg/kg bw/day (G5) and third week of 450 mg/kg bw/day (G4) in the male body weight when compared with control groups of animals.
FOOD CONSUMPTION: No significant changes were observed in feed consumption data of control and treated groups.
HAEMATOLOGY: Significant changes were observed on 29th day in haematological parameters such as clotting time, MCV (G6 high dose reverse males - 1000 mg/kg bw/day) and MCHC (G3 low dose males - 150 mg/kg bw/day) when compared with the control (G1 and G2) groups. However these variations were observed to be within the biological range of these species. No significant changes were observed on the 43th day.
CLINICAL CHEMISTRY: Statistically significant changes were observed on 29th day in biological parameters such as AST (G5-1000 mg/kg bw/ day and G6 high dose reversal - 1000 mg/kg bw/ day), total protein (G6) and cholesterol (G6). However these variations were observed to be within the biological range of this species. No significant changes were observed on the 43th day.
ORGAN WEIGHTS: No significant changes were observed in absolute and relative organ weights of control and treated groups.
GROSS PATHOLOGY AND HISTOPATHOLOGY: No test item related toxicologically significant and histopathological lesions were recorded in any of the treated groups of animals when compared to control groups.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: (no effect observed)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 3: summary of weekly mean body weights (g)
Group |
Sex: male |
||||||
Week |
|||||||
|
0 |
1 |
2 |
3 |
4 |
5 |
6 |
G1 – Control |
223 |
240 |
271 |
291 |
312 |
|
|
G2 –Control Reversal |
221 |
243 |
265 |
286 |
303 |
322 |
336 |
G3 – 150 mg/kg bw |
220 |
244 |
267 |
287 |
307 |
|
|
G4 – 450 mg/kg bw |
219 |
240 |
260 |
280 * |
299 |
|
|
G5 – 1000 mg/kg bw |
217 |
237 |
258 * |
278 * |
303 |
|
|
G6 – 1000 mg/kg bw – Reversal |
216 |
236 |
262 |
282 |
302 |
323 |
338 |
|
Sex: Female |
||||||
G1 – Control |
272 |
284 |
293 |
303 |
312 |
|
|
G2 –Control Reversal |
266 |
279 |
292 |
304 |
316 |
325 |
332 |
G3 – 150 mg/kg bw |
256 |
269 |
280 |
291 |
299 |
|
|
G4 – 450 mg/kg bw |
256 |
267 |
277 |
290 |
300 |
|
|
G5 – 1000 mg/kg bw |
264 |
275 |
288 |
299 |
309 |
|
|
G6 – 1000 mg/kg bw – Reversal |
267 |
279 |
291 |
303 |
314 |
326 |
336 |
*: significant when compared with control group (P<0.05)
Table 4: summary of clinical chemistry parameters Day-29
Group |
Total protein (g/dl) |
Albumin (g/dl) |
Glucose (mg/dl) |
AST (IU/l) |
ALT (IU/l |
Urea (mg/dl) |
Creatinine (mg/dl) |
Cholesterol (mg/dl) |
Total bilirubine (mg/dl) |
Sodium (mEq/L) |
Potassium (mEq/L) |
|
Sex: Male |
||||||||||||
G1 control |
6.62 |
1.22 |
115.60 |
103.4 |
49.00 |
4.33 |
0.38 |
85.40 |
0.14 |
143.00 |
3.53 |
|
G2 control reversal |
6.76 |
1.24 |
105.20 |
136.0 |
50.80 |
6.45 |
0.58 |
74.80 |
0.16 |
143.00 |
3.70 |
|
G3 150 mg/kg |
7.12 |
1.30 |
121.00 |
111.8 |
53.20 |
4.17 |
0.42 |
99.20 |
0.18 |
145.40 |
3.78 |
|
G4 450 mg/kg |
7.36 |
1.30 |
119.40 |
112.6 |
55.20 |
7.00 |
0.52 |
99.40 |
0.16 |
143.20 |
3.71 |
|
G5 1000 mg/kg |
6.94 |
0.98 |
119.60 |
121.6* |
54.20 |
5.62 |
0.40 |
95.00 |
0.14 |
145.80 |
3.66 |
|
G6 1000 mg/kg reversal |
6.62 |
1.28 |
116.00 |
120.0 |
53.00 |
3.82 |
0.48 |
99.40 * |
0.16 |
144.80 |
3.93 |
|
|
Sex: Female |
|||||||||||
G1 control |
6.86 |
1.10 |
115.80 |
119.4 |
47.80 |
8.10 |
0.48 |
98.00 |
0.18 |
142.80 |
3.71 |
|
G2 control reversal |
7.04 |
1.42 |
119.00 |
117.6 |
52.60 |
5.50 |
0.50 |
94.80 |
0.12 |
142.40 |
3.70 |
|
G3 150 mg/kg |
7.04 |
1.24 |
126.40 |
113.4 |
52.40 |
7.37 |
0.46 |
95.40 |
0.14 |
141.80 |
3.61 |
|
G4 450 mg/kg |
6.84 |
1.28 |
111.40 |
130.2 |
45.60 |
8.27 |
0.50 |
100.80 |
0.12 |
144.20 |
3.51 |
|
G5 1000 mg/kg |
6.66 |
1.30 |
114.40 |
127.6 |
48.60 |
7.78 |
0.42 |
106.80 |
0.14 |
143.20 |
3.54 |
|
G6 1000 mg/kg reversal |
6.68 * |
1.36 |
116.80 |
110.4 * |
50.20 |
6.27 |
0.52 |
103.80 |
0.14 |
145.40 |
3.50 |
|
*: significant when compared with control group (P<0.05)
Table5: summary of haematological parameters Day-29
Group |
RBC (106/µl) |
Hb (g/dl) |
HCT (%) |
WBC (106/µl) |
PLT (103/µl) |
CT (Sec) |
L (%) |
M (%) |
G (%) |
MCH (pg) |
MCHC (g/dl) |
MCV (fl) |
|
Sex: Male |
|||||||||||
G1 control |
9.37 |
11.54 |
53.86 |
12.02 |
854.80 |
94.20 |
77.09 |
6.00 |
16.91 |
12.40 |
21.54 |
58.26 |
G2 control reversal |
8.34 |
13.30 |
57.44 |
10.75 |
895.20 |
133.20 |
75.44 |
6.30 |
18.26 |
16.11 |
23.34 |
69.72 |
G3 150 mg/kg |
9.49 |
12.42 |
48.96 |
8.65 |
1033.80 |
103.60 |
74.12 |
7.00 |
18.88 |
13.16 |
25.46 * |
51.79 |
G4 450 mg/kg |
10.02 |
12.72 |
59.24 |
10.53 |
949.80 |
102.00 |
81.06 |
2.98 |
15.96 |
12.76 |
21.50 |
59.35 |
G5 1000 mg/kg |
9.37 |
11.24 |
59.24 |
8.65 |
1033.80 |
96.20 |
78.58 |
4.72 |
16.70 |
12.04 |
19.06 |
63.88 |
G6 1000 mg/kg reversal |
9.75 |
13.26 |
52.78 |
10.06 |
949.80 |
101.00 * |
74.94 |
8.54 |
16.52 |
13.75 |
25.20 |
54.52 |
|
Sex: Female |
|||||||||||
G1 control |
8.52 |
11.62 |
51.56 |
11.71 |
882.60 |
84.60 |
69.62 |
4.62 |
25.76 |
13.79 |
22.68 |
61.46 |
G2 control reversal |
9.06 |
13.08 |
52.86 |
14.88 |
746.40 |
100.60 |
73.08 |
6.36 |
20.56 |
14.48 |
25.02 |
58.39 |
G3 150 mg/kg |
8.81 |
11.40 |
48.96 |
10.68 |
922.40 |
90.80 |
74.27 |
4.68 |
21.05 |
13.15 |
23.38 |
56.56 |
G4 450 mg/kg |
8.73 |
11.44 |
52.60 |
10.01 |
952.40 |
93.20 |
74.69 |
6.66 |
18.65 |
13.11 |
21.91 |
60.46 |
G5 1000 mg/kg |
8.49 |
11.40 |
52.60 |
10.25 |
953.60 |
88.80 |
78.58 |
3.24 |
18.18 |
13.60 |
21.88 |
63.26 |
G6 1000 mg/kg reversal |
8.67 |
12.26 |
50.91 |
11.92 |
1088.60 |
103.20 |
70.80 |
8.54 |
20.66 |
14.24 |
24.29 |
59.04 |
*: significant when compared with control group (P<0.05)
Table 6: summary of relative organ weights (g)
Group |
Adrenal |
Thymus |
Spleen |
Heart |
Brain |
Kidney |
Liver |
Sex: Female |
|||||||
G1 control |
0.011 |
0.130 |
0.290 |
0.270 |
0.573 |
0.516 |
2.763 |
G2 control reversal |
0.013 |
0.127 |
0.273 |
0.260 |
0.552 |
0.542 |
2.801 |
G3 150 mg/kg |
0.012 |
0.124 |
0.311 |
0.285 |
0.611 |
0.577 |
2.766 |
G4 450 mg/kg |
0.013 |
0.136 |
0.316 |
0.290 |
0.603 |
0.540 |
2.954 |
G5 1000 mg/kg |
0.016 |
0.117 |
0.307 |
0.271 |
0.593 |
0.530 |
2.536 |
G6 1000 mg/kg reversal |
0.009 |
0.106 |
0.278 |
0.257 |
0.544 |
0.517 |
2.525 |
Group |
Adrenal |
Epididymes |
Thymus |
Spleen |
Heart |
Brain |
Testes |
Kidney |
Liver |
Sex: Male |
|||||||||
G1 control |
0.012 |
0.306 |
0.116 |
0.366 |
0.313 |
0.596 |
0.965 |
0.603 |
3.118 |
G2 control reversal |
0.011 |
0.277 |
0.110 |
0.348 |
0.285 |
0.572 |
0.861 |
0.564 |
3.006 |
G3 150 mg/kg |
0.011 |
0.296 |
0.131 |
0.440 |
0.319 |
0.630 |
0.978 |
0.601 |
3.153 |
G4 450 mg/kg |
0.015 |
0.315 |
0.126 |
0.424 |
0.313 |
0.628 |
0.974 |
0.623 |
3.244 |
G5 1000 mg/kg |
0.011 |
0.302 |
0.140 |
0.425 |
0.306 |
0.619 |
0.939 |
0.617 |
3.119 |
G6 1000 mg/kg reversal |
0.011 |
0.269 |
0.115 |
0.365 |
0.284 |
0.575 |
0.863 |
0.556 |
2.865 |
Applicant's summary and conclusion
- Conclusions:
- Based on the above observations, the NOEL of Vegeflux Soy for Wistar rats can be considered as greater than 1000 mg/kg bw/day.
- Executive summary:
In a subacute toxicity study (Thanikaivel V, 2008), Vegeflux Soy was administered to 5 Wistar rats/sex/dose by gavage at dose levels of 0, 150, 450 and 1000 mg/kg bw/day for 28 days. The test was performed according to OECD guideline 407 and GLP. This subacute toxicity study in the rat is considered as acceptable.
There were no compound related effects in mortality, clinical signs, body weight, food consumption, haematology, clinical chemistry, organ weights, or gross and histological pathology.
Based on these results, the NOEL of Vegeflux Soy is greater than 1000 mg/kg bw/day.
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