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EC number: 233-215-5 | CAS number: 10081-67-1
- 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
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Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 December 2008 to 13 July 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD test guideline in compliance with GLP and reported with a valid GLP certificate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline
- EC Number:
- 233-215-5
- EC Name:
- 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline
- Cas Number:
- 10081-67-1
- Molecular formula:
- C30H31N
- IUPAC Name:
- 4-(2-phenylpropan-2-yl)-N-[4-(2-phenylpropan-2-yl)phenyl]aniline
- Test material form:
- not specified
- Details on test material:
- Identification: DUSANTOX 86lot number: 005/07Purity: Quality of the test article was declared with Certificate of Analysis No 040707/A9Storage conditions: Long term storage: at room temperature, protected against sunlight Stable: at room temperature for 24 months.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test Animals: 48 adult males and 48 females of Wistar rats from Velaz Praha, Czech Republic were used. The animals were acclimatised for 20 days before the study in the condition identical to the condition during the experiment. The acclimatisation was made according to SOPB-00188-AH, Animals quarantine. The mean bodyweight of animals at the start of experiment was in males 269.8g, in females 185g. Twelve males and twelve females were used in the control and in all dose groups. Husbandry: All animals were kept in cages with bedding in the experimental animal house with standard conditions. The sanitation was made according to standard operation procedure. The temperature was 22± 2°C, relative humidity 45 to 65%. They were followed by a room thermometer and hydrometer placed in the room. The room is equipped with central air-conditioner. The light regime was artificial 12-hour light / 12-hour dark cycle. The keeping of animals was organised to timetable:1. 4 animals in the cage (males and female separately)2. 1 male and 1 female in the cage (mating)3. 1 pregnant female individually4. 1 female and offspring individuallyFood and water: For feeding conventional laboratory diet (Top Dovo, PD Horné Dubové – Naháč) was used with an unlimited supply of drinking water.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- Control article/VehicleIdentification: Olive oil (Olivae oleum raffinatum), product by G. HeessLot number: L 809182Purity: Quality of control article was declared with Certificate.Storage condition: The control article was stored under laboratory conditions in dark container. Justification for choice of vehicle: Dusantox 86 is not soluble in water, but olive oil was used as vehicle. Method of application: The test article was administered per os with the metal stomachic tube everyday at 8 a.m. Doses were calculated on the current bodyweight. The animals were weighed weekly. The fixed application volume of 0.5mL/100g bodyweight was used. Dusantox 86 is not soluble in water; the olive oil was used as a vehicle. The test substance was soluble in olive oil as vehicle every day. The vehicle was applied to control animals in volume 0.5mL/100g bodyweight.
- Details on mating procedure:
- Normally, 1:1 (1 male to 1 female) mating was used in this study. The female was place with the same male until pregnancy occurs or 14 days have elapsed. Every morning during the mating period the females were examined for the presence if sperm or vaginal plugs. Day 0 of pregnancy was defined as the day a vaginal plug or sperm are found. The pregnant female was kept individually up to 4th day post-partum.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not specified.
- Duration of treatment / exposure:
- Males - 28 daysFemales - up to four days after birth (54 days)
- Frequency of treatment:
- Daily
- Details on study schedule:
- Daily dosing of both sexes began 14 days before mating. Dosing was continued in both sexes during mating period (max. 14 days – 2 complete oestrus cycles). Males were dosed after the mating period at least until the minimum total dosing period of 28 days. They were sacrificed by the overdose of anaesthetic (dietylether). Daily dosing of females were continued throughout pregnancy and up to the 4th day after birth. Female showing no evidence of copulation were dosed 29 days after the last day of mating period. They were sacrificed by overdose of anaesthetic. Females with offpring were sacrificed on day 4 post-partum.
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 5, 25 & 50 mg/kg bw/dayBasis:actual ingested
- No. of animals per sex per dose:
- 12 animals per sex, per dose. (Total of 48 rats)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Groups Designation and Dose Levels: Three test groups and control group (vehicle) were used. Twelve animals of both sexes were used in every level group and in the control group.The animals were marked by serial number 1 – 48. All cages were marked with the number of the group, the dose and the serial number of the animals. The animals in the cage were marked by line I – IIII on the tail. Males were coloured with black and females with red. Selection of doses was estimated from available information about the test article. The low dose was estimated for 5mg.kg-1. The high dose level – 50mg.kg-1 represents 10-fold of the low dose level, medium dose level – 25mg.kg-1 represents 5-fold of the low dose level. Males (black)Females (red)ControlOlive oil(12) 1 -12(12) 1 – 12Low dose group5mg.kg-1(12) 13 – 24(12) 13 – 24Medium dose group25mg.kg-1(12) 25 – 36(12) 25 – 36High dose group50mg.kg-1(12) 37 – 48(12) 37 – 48
- Positive control:
- Not utilised in this study.
Examinations
- Parental animals: Observations and examinations:
- General clinical observations were made once a day 1 hour after the test application. The health condition of the animals, reaction of the animals to the applied substance, their condition were monitored every day and recorded. The number of pregnant females was recorded.Bodyweight and Food Consumption: Individual weighing of the adult animals was performed once a week. The bodyweights of animals were recorded.
- Oestrous cyclicity (parental animals):
- Not measured
- Sperm parameters (parental animals):
- Not measured
- Litter observations:
- The number of live pups, weight of litters and sex of pups were observed.
- Postmortem examinations (parental animals):
- The animals were anesthetized with diethylether and necropsied. Males: at the end of the mating period (after 28 days of treatment period) and pregnant females after 4 days post-partum and non-pregnant females 28 days after mating period. Kidneys, testes, epididymides, uterus and ovaries were weighed during the necropsy. The samples from these organs with prostate and glands vesicles were processed for microscopic examination. Those tissue samples were fixed in bouin solution and prepared in the paraffin technical. The tissue segments were sectioned at 10μm by a Leica micrptome and stained with hematoxylin and eosin. The histological section was examined under a light microscope. Macroscopic Evaluation: At the time of death the animals were examined macroscopically for any abnormalities or pathological changes. Special attention was given to the organs of the reproductive system and the kidneys as target organ. The number of corpora lutea and count of implantation sites was monitored. Histopathological Examination: Histopathological evaluations have a prominent role in reproductive toxicity assessment. Detailed histological examination was performed on the uterus, ovaries, testes, epididydimes and kidneys (the target organ) of the animals of control and highest (50mg.kg-1) dose groups. The histopathological examination was made by standard operation procedures.
- Postmortem examinations (offspring):
- Postmorten exmainations not performed on offspring.
- Statistics:
- The results obtained during the study were statistically evaluated by statistical programme Statgraphics. Statistical evaluated was made separately for males, females and litters. For identification homogeneity groups were used the Bartllet’s test. In the case of homogeneity One-Way Analysis of variance with consecutive Multiple Rangers tests was accomplished. In case non homogeneity Kruskal-Wallis One Way Analysis by Ranks was applied.
- Reproductive indices:
- After sacrificed of all females were calculated reproduction indices Number of females with implantsFertility Index = -------------------------------- x 100 Number of females mating Number of females delivering live youngGestation (Pregnancy) Index = --------------------------------------------- x 100 Number of females with evidence of pregnancy Number of live offspringLive Birth Index = --------------------------------- x 100 Number of offspring delivered
- Offspring viability indices:
- Number of live offspring at lactation day 4Viability (Survival) Index = --------------------------------------------- x 100Number of live offspring delivered
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOEC
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical observation, bodyweight of animals, food consumption, length of pregnancy, number of pups and weight of litter, number of corpora lutea and implantation sites, relative weight of organs or macroscopical and histological changes.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOEC
- Generation:
- F1
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical observation, bodyweight of animals, food consumption, length of pregnancy, number of pups and weight of litter, number of corpora lutea and implantation sites, relative weight of organs or macroscopical and histological changes.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Bodyweight, Males
Dose level | N | Bodyweight (g) / Day | ||||
1 | 7 | 14 | 21 | 28 | ||
Control
| 12/12 | 272.50± 12.88 | 286.17± 15.05 | 301.67± 20.38 | 321.67± 21.67 | 330.00± 26.63 |
Low 5mg.kg-1 | 12/12 | 265.83± 16.21 | 280.83± 16.21 | 295.00± 15.08 | 319.17± 18.32 | 325.83± 18.81 |
Medium 25mg.kg-1 | 12/12 | 270.00± 19.54 | 287.50± 23.79 | 299.17± 25.75 | 326.67± 29.65 | 331.67± 30.40 |
High 50mg.kg-1 | 12/12 | 270.83± 15.64 | 281.67± 19.92 | 299.17± 27.12 | 322.50± 31.66 | 329.17± 31.18 |
Table 2. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Bodyweight, Pre-Mating Period, Females
Dose level | N | Bodyweight (g) / Day | ||
1 | 7 | 14 | ||
Control | 12/12 | 185.83± 9.96 | 186.67± 10.73 | 190.83± 9.00 |
Low 5mg.kg-1 | 12/12 | 186.67± 9.85 | 185.83± 10.84 | 190.00± 11.28 |
Medium 25mg.kg-1 | 12/12 | 183.33± 11.55 | 185.00± 7.98 | 188.33± 10.30 |
High 50mg.kg-1 | 12/12 | 184.17± 7.93 | 186.67± 12.31 | 188.33± 10.30 |
Table 3. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Bodyweight, Mating Period, Females
Dose level | N | Bodyweight (g) / Day | ||
1 | 7 | 14 | ||
Control | 12/12 | 198.33± 9.37 | 215.83± 12.40 | 235.00± 11.68 |
Low 5mg.kg-1 | 12/12 | 199.17± 10.84 | 216.67± 16.14 | 232.50± 23.79 |
Medium 25mg.kg-1 | 12/12 | 198.33± 11.93 | 209.17± 13.11 | 230.83± 14.43 |
High 50mg.kg-1 | 12/12 | 200.83± 11.65 | 210.83± 12.40 | 230.83± 11.65 |
Table 4. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Bodyweight, Pregnancy, Females
Dose level | N | Bodyweight (g) / Day | ||
1 | 14 | 21 | ||
Control | 12/12 | 200.00± 9.54 | 235.00± 11.68 | 281.67± 27.1 |
Low 5mg.kg-1 | 12/12 | 202.22± 9.72 | 240.00± 18.71 | 288.89± 28.92 |
Medium 25mg.kg-1 | 12/12 | 208.18± 13.28 | 232.73± 14.89 | 280.00± 24.08 |
High 50mg.kg-1 | 12/12 | 210.83± 12.40 | 232.50± 14.22 | 283.33± 25.70 |
N-Number of animals, the results are presented as mean± SD
Table 5. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Bodyweight, F1 generation (Offspring)
Dose level | Bodyweight (g) / Day | |||
N | 1 | N | 4 | |
Control | 102 | 53.33± 30.25 | 101 | 70.83± 38.49 |
Low 5mg.kg-1 | 78 | 51.67± 23.98 | 78 | 75.56± 34.68 |
Medium 25mg.kg-1 | 79 | 43.64± 23.99 | 77 | 61.36± 35.08 |
High 50mg.kg-1 | 112 | 58.75± 17.34 | 110 | 77.92± 25.89 |
N-Number of pups, the results are presented as mean± SD
Table 6. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Mean Number of Corpora Lutea and Implantation Sites
Dose level | N | Corpora Lutea | Implantation Sites |
Control | 12/12 | 13.00± 2.13 | 11.08± 3.50 |
Low 5mg.kg-1 | 12/9 | 10.67± 1.41 | 10.33± 1.00 |
Medium 25mg.kg-1 | 12/11 | 11.73± 1.56 | 11.36± 1.21 |
High 50mg.kg-1 | 12/12 | 12.58± 2.39 | 11.83± 1.95 |
N-Number of females, the results are presented as mean± SD
Table 11. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Relative Weight of Organs, Males
Dose level | N | Kidneys (g) | Testis (g) | Epididymis (g) | |||
Right | Left | Right | Left | Right | Left | ||
Control | 12/12 | 0.36± 0.03 | 0.36± 0.02 | 0.46± 0.05 | 0.48± 0.07 | 0.089± 0.013 | 0.090± 0.010 |
Low 5mg.kg-1 | 12/12 | 0.36± 0.03 | 0.35± 0.03 | 0.48± 0.04 | 0.47± 0.04 | 0.086± 0.011 | 0.089± 0.012 |
Medium 25mg.kg-1 | 12/12 | 0.36± 0.03 | 0.35± 0.03 | 0.46± 0.06 | 0.47± 0.06 | 0.088± 0.011 | 0.085± 0.010 |
High 50mg.kg-1 | 12/12 | 0.38± 0.04 | 0.37± 0.04 | 0.49± 0.05 | 0.51± 0.07 | 0.094± 0.011 | 0.097± 0.011 |
Table 12. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Relative Weight of Organs, Females
Dose level | N | Kidneys (g) | Ovaries (g) | Uterus (g) | ||
Right | Left | Right | Left | |||
Control | 12/12 | 0.037± 0.03 | 0.37± 0.02 | 0.38± 0.06 | 0.36± 0.07 | 0.29± 0.09 |
Low 5mg.kg-1 | 12/12 | 0.37± 0.04 | 0.35± 0.04 | 0.40± 0.08 | 0.41± 0.10 | 0.27± 0.04 |
Medium 25mg.kg-1 | 12/12 | 0.37± 0.03 | 0.36± 0.03 | 0.38± 0.11 | 0.38± 0.09 | 0.29± 0.07 |
High 50mg.kg-1 | 12/12 | 0.38± 0.04 | 0.36± 0.04 | 0.34± 0.03 | 0.37± 0.05 | 0.27± 0.05 |
N-Number of animals, the results are presented as mean± SD
Table 13. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Percentage Evaluation of Results in Females
Dose level | N | Sperm-positive (%) | Pregnant (%) | With Live Pups (%) |
Control | 12/12 | 100 | 100 | 83.33 |
Low 5 mg.kg-1 | 12/9 | 75 | 75 | 66.67 |
Medium 25mg.kg-1 | 12/11 | 91.67 | 91.67 | 83.33 |
High 50mg.kg-1 | 12/12 | 100 | 100 | 100 |
N-Number of females
Table 14. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – F1 Generation (Offspring)
Dose level | Number of Pups | Live Pups (%) | Death Pups (%) | |||
Total | Mean/1 Female | Live | Death | |||
Control | 109 | 9 | 102 | 7 | 93.58 | 6.42 |
Low 5mg.kg-1 | 82 | 9 | 78 | 4 | 95.12 | 4.88 |
Medium 25mg.kg-1 | 90 | 8 | 79 | 11 | 87.78 | 12.22 |
High 50mg.kg-1 | 113 | 9 | 112 | 1 | 99.12 | 0.89 |
Table 15. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Indices of Reproductive Parameters (%)
Dose level | Fertility | Gestation | Live Birth | Viability |
Control | 100 | 83.33 | 93.58 | 98.80 |
Low 5mg.kg-1 | 75 | 88.89 | 95.12 | 100 |
Medium 25mg.kg-1 | 91.67 | 90.91 | 87.78 | 97.47 |
High 50mg.kg-1 | 100 | 100 | 99.12 | 98.21 |
Table 16. Dusantox 86. Reproduction/Developmental Toxicity Screening Test (OECD 421) – Sex Distribution of Pups
Dose level | Total Number | Males | % | Females | % |
Control | 100 | 53 | 53.00 | 47 | 47.00 |
Low 5mg.kg-1 | 78 | 37 | 47.44 | 41 | 52.56 |
Medium 25mg.kg-1 | 77 | 36 | 46.75 | 41 | 53.25 |
High 50 mg.kg-1 | 110 | 49 | 49.00 | 61 | 61.00 |
Sex distribution – 4thday post-partum
Applicant's summary and conclusion
- Conclusions:
- The results of this study indicated that per os application of the test article Dusnatox 86 didn’t show any significant changes in all used doses in comparison with the control animals:in clinical observation, bodyweight of animals, food consumption, length of pregnancy, number of pups and weight of litter, number of corpora lutea and implantation sites, relative weight of organs or macroscopical and histological changes.
- Executive summary:
This study was used to provide initial information on possible effects on reproduction and/or development, which may be evoked by Dusantox 86. The Wistar rats, 48 adult males and 48 adult females were divided into four groups. Three groups received the test article Dusantox 86 in graduated doses. The control group received the vehicle. Dusantox 86 is not soluble in water; olive oil was used as a vehicle. The dose of 5mg.kg-1was estimated as the low dose, the dose of 25mg.kg-1as the medium dose level and as the high dose level was selected 50mg.kg-1. Doses were calculated on the current bodyweight. The test article and vehicle were administered per os by metal stomachic tube every day. The males were applied 28 days – 14 days per-mating, 14 days mating. This dosing period (28 days) is considered sufficient to enable detection of the majority of effects on male fertility and spermatogenesis. The females were applicated 54 days – 14 days pre-mating, 14 days mating (with the objective of covering at least two complete oestrus cycles), 22 days gestation, and 4 days lactation. The application volume 0.5mL/100g weight was administered. All animals were monitored for signs of toxicity during application of the test article. All animals were weighed weekly. The bodyweight, food consumption and clinical observation were observed during the study. After finishing the test all animals were sacrificed by overdosing of anaesthetic and moved to macroscopical and histological evaluation. The organs of the reproductive system (the uterus, ovaries, testes, epididydimes, and accessory sex organs) and the kidneys as target organ were monitored. The number of implantation sites and corpora lutea was recorded. The results were elaborated in for of tables. The statistical programme Statgraphics was used for statistically evaluation of the results.
There were no test article-related deaths of animal during the study. There were not any visible signs of intoxication in all animals during clinical observation. The incidence of smooth stool in one animal of dose group 50mg.kg-1males and diarrhoea in one male of dose group 25mg.kg-1were observed. The incidence of alopecia in one female dose group of 50mg.kg-1was observed. These incidences were temporary and may not be indicate relation to the test application. The bodyweight of all animals moderately increased during the study. There were no significant differences between all dose groups and the control groups.
The food consumption was adequate. In control (olive oil) and highest (50mg.kg-1) dose groups 12 females were pregnant. In dose group 5mg.kg-19 females were pregnant and in dose group 25mg.kg-111 females were pregnant. In female dose group 5mg.kg-1three animals and in dose group 25 mg.kg-1one animal were not pregnant. The number of alive pups in all females of the control and all dose groups was stable. The relative weight of kidneys and reproduction organs in both sexes were without statistical differences. Number of corpora lutea and count of implantation sites in females of all dose groups and in the control group were without statistical differences. Detailed histological examination was performed on reproduction organs and kidneys (target organs) of the males and female of the control and the highest dose group. Macroscopical and histopathological findings showed that Dusantox 86 did not cause pathological lesions in organs of treated animals. The sporadic presence of lesions in the animals of the high dose groups was similar to control groups.
CONCLUSION
The results of this study indicated that per os application of the test article Dusnatox 86 didn’t show any significant changes in all used doses in comparison with the control animals:
in clinical observation, bodyweight of animals, food consumption, length of pregnancy, number of pups and weight of litter, number of corpora lutea and implantation sites, relative weight of organs or macroscopical and histological changes.
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