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EC number: 947-818-2 | 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- July, 2016
- Deviations:
- no
- Remarks:
- No deviations occurred that negatively impacted the results of the study.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate
- EC Number:
- 947-818-2
- Cas Number:
- 1612783-92-2
- Molecular formula:
- C15H28O2
- IUPAC Name:
- Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 6
- Expiration date of the lot/batch: 04 October, 2019
- Purity test date: 04 October, 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Kept in a controlled temperature area set to maintain 18°C to 24°C
- Stability under test conditions: Stable per analytical verification of test article formulations in corn oil
- Solubility and stability of the test substance in the solvent/vehicle: Soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Non-reactive
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was prepared in corn oil
FORM AS APPLIED IN THE TEST: Prepared in corn oil.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- The Crl:CD(SD) rat is recognized as appropriate for reproduction studies. Charles River Ashland has reproductive historical control data in this species from the same strain and source. This animal model has been proven to be susceptible to the effects of reproductive toxicants.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Raleigh, NC
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 10 weeks
- Weight at study initiation: 203-395 g
- Fasting period before study: None
- Housing: On arrival, animals were group housed (up to 3 animals of the same sex) until cohabitation. During cohabitation, animals were paired for mating in the home cage of the male. Following the breeding period, animals were individually housed. Animals were housed in solid-bottom cages containing appropriate bedding equipped with an automatic watering valve throughout the study.
Animals were separated during designated procedures/activities. Each cage was clearly labeled with a color-coded cage card indicating study, group, animal, cage number(s), dosage level, and sex. Cages were arranged on the racks in group order.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC Certified Rodent LabDiet® 5002 was provided ad libitum throughout the study.
- Water (e.g. ad libitum): Municipal tap water after treatment by reverse osmosis was freely available to each animal via an automatic watering system
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 June, 2018 To: 10 August, 2018
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test article was dissolved in corn oil.
VEHICLE
- Justification for use and choice of vehicle: Test article solubility and test system tolerance.
- Concentration in vehicle: 8, 30, or 140 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg body weight
- Lot/batch no. (if required): 2GK0223
- Purity: No data - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: Until evidence of mating was confirmed via copulatory plug or sperm in a vaginal lavage.
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy
- Further matings after two unsuccessful attempts: No, only one attempt at mating was conducted.
- After successful mating each pregnant female was caged (how): Individually - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Duplicate sets of samples (1.0 mL) for each sampling time point were transferred to the analytical laboratory; the remaining samples were retained at the Testing Facility as backup samples. Concentration results were considered acceptable if mean sample concentration results were within or equal to ± 15% of theoretical concentration. After acceptance of the analytical results, backup samples were discarded.
Duplicate sets of samples (1.0 mL) from the first preparation were transferred to the analytical laboratory; the remaining samples were retained at the Testing Facility as backup samples. Homogeneity results were considered acceptable if the relative standard deviation of the mean value at each sampling location was ≤ 10% and if mean sample concentration results were within or equal to ± 15% of theoretical concentration. After acceptance of the analytical results, backup
samples were discarded. - Duration of treatment / exposure:
- The test substance and vehicle were administered as a single daily oral gavage dose. Males were dosed for 14 days prior to mating and continuing through mating, for a minimum of 28 days, until 1 day prior to euthanasia. Females were dosed for 14 days prior to mating and continuing through Lactation Day 12. All animals were dosed at approximately the same time each day
- Frequency of treatment:
- Daily
- Details on study schedule:
- Males were dosed for 14 days prior to mating and continuing through mating, for a minimum of 28 days, until 1 day prior to euthanasia. Females were dosed for 14 days prior to mating and continuing through lactations Day 12. All animals were dosed at approximately the same time each day. The following parameters and endpoints were evaluated in this study: clinical signs, body weights, food consumption, estrous cycles, reproductive performance, parturition, litter viability and survival, anogenital distance, areolae/nipple anlagen, thyroid hormones, gross necropsy findings, organ weights, and histopathology. At necropsy, the adrenal glands, brain, epididymides, heart, kidneys, liver, ovaries (with oviducts), pituitary gland, prostate gland, seminal vesicle (with coagulating gland and fluid), spleen, testes, thymus gland, and thyroid were weighed. Tissue samples of the brain, coagulating gland, kidneys, liver, mammary glands, ovaries with oviducts, pituitary gland, prostate gland, seminal vesicles (2), testes with epididymides (2), vas deferens, thyroid with parathydroids (2), uterus with cervix and vagina, and gross lesions were collected at necropsy from all animals. Histopathological examination was performed on the tissue samples collected (except the liver, kidney, and thyroid) from animals in the control and high-dose groups and gross lesions were examined from all groups. 1 pup/sex/litter was subjected to a complete necropsy examination, with emphasis on developmental morphology and organs of the reproductive system.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Vehicle Control (Corn Oil)
- Dose / conc.:
- 40 mg/kg bw/day
- Dose / conc.:
- 150 mg/kg bw/day
- Dose / conc.:
- 700 mg/kg bw/day
- No. of animals per sex per dose:
- 10
- Details on study design:
- - Dose selection rationale: The dose levels were selected based on a 28 day study conducted on a structural analog.
- Rationale for animal assignment (if not random): Random - Positive control:
- None
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Throughout the study, animals were observed for general health/mortality and moribundity twice daily, once in the morning and once in the afternoon. Animals were not removed from cage
during observation, unless necessary for identification or confirmation of possible findings.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: The animals were removed from the cage, and a detailed clinical observation was performed once daily throughout the study. During the dosing period, these observations were performed
prior to dosing. On dosing days, clinical observations were also recorded approximately 4 hours postdose.
BODY WEIGHT: Yes
- Time schedule for examinations: Animals were weighed individually bi-weekly throughout the study and prior to the scheduled necropsy. Once evidence of mating was observed, female body weights were recorded on Gestation Days 0, 4, 7, 11, 14, 17, and 20 and on Lactation Days 0 (if possible), 1, 4, 7, 10, and 13. - Oestrous cyclicity (parental animals):
- For all females, vaginal lavages were performed daily for 14 days prior to randomization and continuing until evidence of mating was observed. The slides were microscopically examined to determine the stage of the estrous cycle. The average cycle length was calculated for complete estrous cycles (i.e., the total number of returns to metestrus [M] or diestrus [D] from estrus [E] or proestrus [P] for 14 consecutive days before cohabitation and until the detection of evidence of
mating). Estrous cycle length was determined by counting the number of days from the first M or D in a cycle to the first M or D in a subsequent cycle. The cycle during which evidence of mating was observed for a given animal was not included in the individual mean estrous cycle length calculation. Vaginal lavages were also performed on the day of necropsy to determine the stage of the estrous cycle. - Sperm parameters (parental animals):
- Parameters examined in F0 male parental generations:
testis weight, epididymis weight, seminal vesicles - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: No - screening study
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical abnormalities, anogenital distance (AGD), presence of nipples/areolae in male pups, throid hormone evaluation.
GROSS EXAMINATION OF DEAD PUPS:
Yes, for external and internal abnormalities.
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals were sacrificed on Study Day 30.
- Maternal animals: All surviving animals were sacrificed on Lacatation Day 13.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. Animals were subjected to a complete necropsy examination, which included examination of the external surface, all orifices, the cranial cavity, the external surface of the brain, and the thoracic, abdominal, and pelvic cavities, including viscera. The numbers of former implantation sites were recorded for females that delivered. The number of unaccounted-for sites was calculated for each female by subtracting the number of pups born from the number of former implantation sites observed
HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were weighed at necropsy:
Adrenal glands
Brain
Epididymides
Heart
Kidneys
Liver
Ovaries (with oviducts)
Pituitary gland
Prostate gland
Seminal vesicle (with coagulating gland and fluid)
Spleen
Testes
Thymus gland
Thyroid (with parathyroids)
The following tissues were collected and examined microscopically:
Brain
Coagulating gland
Kidneys
Liver
Mammary glands
Ovaries with oviducts (2)
Pituitary gland
Prostate gland
Seminal vesicles (2)
Testes with epididymides (2) and vas deferens
Thyroid with parathyroids (2)
Uterus with cervix and vagina
Gross lesions - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed at Postnatal Day (PND) 13
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
On PND 13, 1 pup/sex/litter was subjected to a complete necropsy examination, with emphasis on developmental morphology and organs of the reproductive system. All other animals were discarded without examination.
GROSS NECROPSY
On PND 13, 1 pup/sex/litter was subjected to a complete necropsy examination, with emphasis on developmental morphology and organs of the reproductive system. All other animals were discarded without examination.
HISTOPATHOLOGY / ORGAN WEIGTHS
Representative specimens with malformations from offspring found dead or euthanized for humane reasons were preserved in 10% neutral buffered formalin. Thyroid were weighed at necropsy. - Statistics:
- Each mean was presented with the standard deviation (S.D.) and the number of animals or cages (N) used to calculate the mean. Where applicable, the litter was used as the experimental unit. Statistical analyses were not conducted on F0 bi-weekly female body weight data after 1 or more animals had entered the gestation phase. Due to the use of significant figures and the different rounding conventions inherent in the types of software used, the means and standard deviations on the summary and individual tables may differ slightly. Therefore, the use of reported individual values to calculate subsequent parameters or means will, in some instances, yield minor variations from those listed in the report data tables. All statistical tests were performed using WTDMS™ unless otherwise noted. Analyses were conducted using two-tailed tests (except as noted otherwise) for minimum significance levels of 1% and 5%, comparing each test substance-treated group to the control group by sex.
Parental mating, fertility, copulation, and conception indices were analyzed using the Chi-square test with Yates’ correction factor. Parental and offspring body weights and body weight changes, parental food consumption, estrous cycle lengths, precoital intervals, gestation lengths, former implantation sites, unaccounted-for sites, live litter size on PND 0, numbers of pups born, absolute and relative organ weights, thyroid hormone values, anogential distance (absolute and relative to the cube root of body weight), and number of nipples/areolae values were subjected to a parametric one-way ANOVA10 to determine intergroup differences. If the ANOVA revealed significant (p < 0.05) intergroup variance, Dunnett's test was used to compare the test substance-treated groups to the control group. Histopathological findings of each treated group were analyzed using Fisher’s Exact Test. - Reproductive indices:
- For all females, vaginal lavages were performed daily for 14 days prior to randomization and continuing until evidence of mating was observed. The slides were microscopically examined to determine the stage of the estrous cycle. The average cycle length was calculated for complete estrous cycles (i.e., the total number of returns to metestrus [M] or diestrus [D] from estrus [E] or proestrus [P] for 14 consecutive days before cohabitation and until the detection of evidence of
mating). Estrous cycle length was determined by counting the number of days from the first M or D in a cycle to the first M or D in a subsequent cycle. The cycle during which evidence of mating was observed for a given animal was not included in the individual mean estrous cycle length calculation. Vaginal lavages were also performed on the day of necropsy to determine the stage of the estrous cycle.
Parental mating, fertility, copulation, and conception indices, precoital intervals, gestation lengths, former implantation sites and unaccounted-for sites were all calculated or recorded. - Offspring viability indices:
- Live litter size, numbers of pups born, sex percentages at birth, postnatal survival.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No test substance-related clinical findings were noted.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- All F0 animals survived to the scheduled necropsy.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Mean body weights and body weight gains in the 40, 150, and 700 mg/kg/day group animals were unaffected by test substance administration throughout the study. None of the differences from the control group were statistically significant.
- Description (incidence and severity):
- Mean food consumption, evaluated as g/animal/day, in the 40, 150, and 700 mg/kg/day group males and females was similar to that in the control group throughout the study. No statistically significant differences were observed.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- There were no test substance-related histologic changes.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- There were no test substance-related histologic changes.
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- The mean lengths of estrous cycles in these groups were similar to the control group value.
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No test article-related changes were noted in testis weight, epididymis weight, seminal vesicles.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No test substance-related effects on reproductive performance were observed at any dosage level. No statistically significant differences were noted between the control and test substance-treated groups. All males sired a litter and all females were gravid.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 700 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- histopathology: neoplastic
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The general physical condition (defined as the occurrence and severity of clinical observations) of all F1 pups in this study was unaffected by test substance administration.
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- Three (2), 2(2), 10(4), and 5(5) pups (litters) in the control, 40, 150, and 700 mg/kg/day groups, respectively, were found dead or euthanized in extremis. No internal findings that could be attributed to parental test substance administration were noted at the necropsies of pups that were found dead or euthanized in extremis. Aside from the presence or absence of milk in the stomach, the only internal findings were noted for a single pup (No. 5707-01) in the 40 mg/kg/day group. This pup had malformations of cyclopia, vertebral anomaly without associated rib anomaly, and costal cartilage anomaly. In addition, variations of vertebral centra not fully ossified and distended ureters were noted for this pup. However, these findings did not occur in a dose-related manner, and therefore were not considered test substance-related.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Mean male and female pup body weights and body weight changes during PND 1–13 in the 40, 150, and 700 mg/kg/day groups were unaffected by parental administration of the test substance.
No statistically significant differences from the control group were noted. - Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- There were no test substance-related effects on serum levels of T4 (thyroxine), or TSH (thyroid stimulating hormone) in F1 males and females at any dosage level.
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No internal findings were noted at the necropsy of pups euthanized on PND 13.
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Areolae/nipple anlagen in the F1 male pups was unaffected by parental administration of the test substance when evaluated on PND 13. The test substance-treated group values were not statistically different from the control group values.
The anogenital distances (absolute and relative to the cube root of pup body weight) in the 40, 150, and 700 mg/kg/day groups were similar to the control group values. Differences from the control group were slight and not statistically significant.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 700 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- mortality
- body weight and weight gain
- clinical biochemistry
- gross pathology
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, due to the absence of adverse effects at any dosage level, a dosage level of 700 mg/kg/day was considered to be the no-observed-adverse-effect level (NOAEL) for F0 systemic toxicity, F0 reproductive toxicity, and F1 neonatal toxicity of MTDID 44430 when administered orally by oral gavage to rats.
- Executive summary:
The objective of this study was to provide data on the potential effects of MTDID 44430 on reproductive performance, pup development, and general toxicity of rats by oral exposure. The study was conducted according to OECD 421 under OECD GLP conditions. Four groups of rats (n= 10/sex) received 0 (control), 40, 150, and 700 mg/kg MTDID 44430 in corn oil as a single daily oral gavage dose. Males were dosed for 14 days prior to mating and continuing through mating, for a minimum of 28 days, until 1 day prior to euthanasia. Females were dosed for 14 days prior to mating and continuing through lactations Day 12. All animals were dosed at approximately the same time each day. The following parameters and endpoints were evaluated in this study: clinical signs, body weights, food consumption, estrous cycles, reproductive performance, parturition, litter viability and survival, anogenital distance, areolae/nipple anlagen, thyroid hormones, gross necropsy findings, organ weights, and histopathology. At necropsy, the adrenal glands, brain, epididymides, heart, kidneys, liver, ovaries (with oviducts), pituitary gland, prostate gland, seminal vesicle (with coagulating gland and fluid), spleen, testes, thymus gland, and thyroid were weighed. Tissue samples of the brain, coagulating gland, kidneys, liver, mammary glands, ovaries with oviducts, pituitary gland, prostate gland, seminal vesicles (2), testes with epididymides (2), vas deferens, thyroid with parathydroids (2), uterus with cervix and vagina, and gross lesions were collected at necropsy from all animals. Histopathological examination was performed on the tissue samples collected (except the liver, kidney, and thyroid) from animals in the control and high-dose groups and gross lesions were examined from all groups. 1 pup/sex/litter was subjected to a complete necropsy examination, with emphasis on developmental morphology and organs of the reproductive system. RESULTS: All F0 animals survived to the scheduled necropsy. No test substance-related clinical findings were noted. There were no statistically significant changes in mean body weight, mean food consumption, reproductive performance, parturition, thyroid hormones, anogenital distance, areolate/nipple anlagen, litter viability and survival. There were no test substance-related changes in organ weight, gross pathology, and histopathology. No internal findings were noted at the necropsy of euthanized pups. Under the conditions of this study, due to the absence of adverse effects at any dosage level, a dosage level of 700 mg/kg/day was considered to be the no-observed-adverse-effect level (NOAEL) for F0 systemic toxicity, F0 reproductive toxicity, and F1 neonatal toxicity of MTDID 44430 when administered orally by oral gavage to rats.
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