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EC number: 257-446-6 | CAS number: 51818-55-4
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No data on toxicity to reproduction were available for the target substance Neodecanoic acid, iron salt. Therefore, data from suitable read-across partners Neodecanoic acid and soluble iron salts (as Iron sulphate heptahydrate and Iron dichloride) were used to assess the reproductive toxicity of Neodecanoic acid, iron salt. For details and justification of read-across please refer to the report attached in section 13 of IUCLID.
In two screening studies for reproductive/developmental toxicity performed with Iron sulphate heptahydrate and Iron dichloride in rats, no adverse effects were seen on any reproductive or developmental toxicity parameters up to the highest doses tested, while signs of maternal toxicity were evident at low to mid dose levels.
In addition, from a three-generation study performed with the read-across partner, Neodecanoic acid, no adverse effects on reproduction were observed.
Based on the results from suitable read-across partners, Neodecanoic acid, iron salt is not considered to exert toxic effects on reproduction.
Link to relevant study records
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the report attached in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One control P1 female was found dead following the second mating period (F1B). The right adrenal was enlarged and dark red in color, and the lungs were dark red in color. The observation was not considered treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Two intermediate dose P1 males were found dead following the first (F2A) mating period. The gastrointestinal tract of both animals was filled with gas, the lungs of one were dark gray in color, and the lungs of the other were distended and dark red with grayish areas. One control P1 female was found dead following weaning of the F2B litter. Necropsy findings included advanced autolysis; pituitary and thymus dark red consolidated and abscessed areas on lungs; liver and kidneys dark red with dark black areas; poor differentiation between cortex and medulla of kidneys; pyloric portion of stomach red; and intestinal tract red and contained blackish red, semithick material. The observations were not considered treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- Mutilation of pups found dead at birth was noted in one control and two high level F1 litters. The observation was not considered treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- no effects observed
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1a
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1b
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- Mutilation of pups found dead at birth or during the nursing period was noted in one control F2 litter and in one low level litter in the F2A and F2B cycles each. The observation was not considered treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2a
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2b
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- In conclusion, no adverse effects on reproduction or development were noted.
- Executive summary:
In a three-generation reproduction study (equivalent to OECD 416), the effects of long-term ingestion of neodecanoic acid on reproduction was evaluated in albino rats. Neodecanoic acid was administered in the diet at levels of 100, 500, and 1500 ppm fed to the rats through two parental and to two-litter filial generations. Following nine weeks of dietary administration to the F2B weanlings designated as the third parental generation, the study was terminated. There was no evidence at any test level of an adverse effect on the survival, appearance, behavior, body weight gain, and food consumption of the parental generations; on the reproductive performance of the parents reflected by the various indices; or on the growth, appearance, and behavior of the offspring. Gross and macroscopic pathological findings revealed no evidence of a compound-related effect at any of the dietary levels. Based on these results, the NOAEL (F0, F1 and F2) is considered to be greater than 1500 ppm.
This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the attached report in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs such as blackish stool and salivation were observed in both the control and the treated groups. In the early stages of administration, cases of decrease in locomotion activity were found in 500 mg/kg bw/day groups of both sexes, but these were recovered to normal states. The female rats were more sensitively affected than the male rats in locomotion activity decrease, paleness, emaciation and soiled perineal region. However, these symptoms were reversible within the test period.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- No death was observed for male animals. Three female rats in 500 mg/kg bw/day treatment group were found dead on the day 38, 46 and 51 of adminstration.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The rate of body weight gain was significantly decreased in 250 and in 500 mg/kg bw/day male groups. For females, there was no significant changes except on the day 7 of pre-mating period and the day 4 of lactation period. Further, no dose-dependent changes were shown.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There was no significant difference between the control and the treated groups, and no dose-related change was observed in both sexes.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- In the 500 mg/kg bw/day treatment group, the amount of water consumption was increased for both male and female animals.
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Statistically significant differences were found in mean cell volume (MCV), eosinophils (EOS), platelet (PLT). But these were within the biologically normal range and no dose-dependent changes were evident.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Significant differences were found in cholinesterase (CS), and triglycerides (TG). But these were within the biologically normal range and no dose-dependent changes were evident.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No adverse effects observed.
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- For 500 mg/kg bw/day groups of both sexes, hemosiderin deposit of hepatocyte and grandular, hyperplasia of zona fasciculate in adrenal cortex, hyperkeratosis of forestomach, hemosiderin deposit of grandular stomach, neutrophil infiltration of submusoca were observed. These conditions were induced by the test substance and were weaker in females. There was no specific findings in the recovery groups. In case of dead rats, due to severe villous atrophy of forestomach, gastric function was abnormal. Therefore, it was concluded that female rats were dead by a physical irritance of test substance.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- maternal
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- water consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- maternal
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- organ weights and organ / body weight ratios
- other: in addtion to the findings as described for the females, males also showed at 250 mg/kg bw/day reduced organ weights.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- System:
- gastrointestinal tract
- Organ:
- stomach
- other: severe villous atrophy of forestomach due to irritant properties of test substance
- Treatment related:
- yes
- Dose response relationship:
- yes
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect on fertility observed
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422), the test item Iron dichloride (99.8% purity) was administered to male and female Sprague Dawley rats/dose by gavage at dose levels of 0, 125, 250 and 500 mg/kg bw/day. Based on the results, the NOAEL for paternal toxicity was determined to be 125 mg/kg bw/day in males and 250 mg/kg bw/day in females. No adverse effects were seen on fertility and reproduction parameters. Thus, the NOAEL for reproductive/developmental toxicity can be considered to be 500 mg/kg bw/day.
- Executive summary:
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422), the test item Iron dichloride (99.8% purity) was administered to male and female Sprague Dawley rats/dose by gavage at dose levels of 0, 125, 250 and 500 mg/kg bw/day. The animals were treated with the test item formulation on 7 days per week for a period of 42 days for males and 40 to 54 days for females.
By the particular test results such as the reduced rate of body weight gain, increased water consumption, increased organ weights, effects seen in gross and histopathology, the NOAEL for parental toxicity was determined to be 125 mg/kg bw/day in males and 250 mg/kg bw/day in females (equivalent to 566 and 1131 mg/kg bw/day Neodecanoic acid, iron salt in males and females referring to the iron content, respectively).
No adverse effects were seen on fertility and reproduction parameters. Thus, the NOAEL for reproductive/developmental toxicity can be considered to be 500 mg/kg bw/day (equivalent to 2248 mg/kg bw/day Neodecanoic acid, iron salt referring to the iron content, respectively).
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the attached report in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Transient salivation was found in the both sexes at 300 and 1000 mg/kg bw/day. Soiled perineal region was observed in males at 1000 mg/kg bw/day.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Death was noted in one male on day 27 of administration and in one female on day 19 of gestation at 1000 mg/kg bw/day, but cause of death was not clarified.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Low body weight was recorded on days 11-49 of administration in males at 1000 mg/kg bw/day, and tendency of low body weight was found on day 21 of gestation in females at 1000 mg/kg bw/day.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Transiently reduced food consumption was observed on day 3 of administration in the both sexes at 1000 mg/kg bw/day.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Males: Decreased red blood cell count and ATPP and increased MCV, MCH and the reticulocyte count were noted at 1000 mg/kg bw/day.
Females: No effects - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - Males: Decreased total protein, albumin and Ca and increased ALT, gamma-GTP and A/G were noted at 1000 mg/kg bw/day.
- Females: Increased levels of gamma-GTP at 1000 mg/kg bw/day, and increased levels of inorganic phosphate at 300 and 1000 mg/kg bw/day were observed. Increased levels of inorganic phosphate were not considered to have toxicological meaning of this chemical because no related changes were found. - Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - Males: An increased urine volume and a decreased specific gravity were noted at 1000 mg/kg bw/day.
- Females: no effect - Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histopathological examinations of the testis, epididymis, prostate, seminal vesicle, ovary, uterus and vagina revealed no significantly toxicological changes.Number of implantations was decreased at 100 and 1000 mg/kg bw/day. These changes were not considered to be due to toxic effects of this chemical, because the values at 100 and 1000 mg/kg bw/day were within the range of historical control data and there were no dose-dependency nor changes in implantation index.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No adverse effects were observed in any reproductive and developmental parameter.
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- maternal
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- haematology
- clinical biochemistry
- histopathology: non-neoplastic
- other: based on effects observed in the repeated dose toxicity part of the study
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect on any reproductive or developmental toxicity parameter
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422), the test item Iron sulphate heptahydrate was administered to male and female CD(SD) rats by gavage at dose levels of 0, 30, 100, 300 and 1000 mg/kg bw/day. Based on the results, the NOAEL for maternal toxicity was determined to be 100 mg/kg bw/day in both sexes. No adverse effects were seen on any reproductive or developmental toxicity parameters. Thus, the NOAEL for reproductive/developmental toxicity can be considered to be 1000 mg/kg bw/day.
- Executive summary:
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422), the test item Iron sulphate heptahydrate was administered to male and female CD(SD) rats by gavage at dose levels of 0, 30, 100, 300 and 1000 mg/kg bw/day. Based on the changes in urinalysis, hematological examinations, organ weight and histopathological findings in males and females, the NOAEL for maternal toxicity was determined to be 100 mg/kg bw/day in both sexes (equivalent to 205 mg/kg bw/day Neodecanoic acid, iron salt in males and females referring to the iron content, respectively. No adverse effects were seen on any reproductive or developmental toxicity parameters. Thus, the NOAEL for reproductive/developmental toxicity can be considered to be 1000 mg/kg bw/day (equivalent to 2049 mg/kg bw/day Neodecanoic acid, iron salt referring to the iron content, respectively).
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Referenceopen allclose all
No effects noted
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
No effects noted
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
No effects noted
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
No effects noted
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
No effects noted
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
No effects noted
ORGAN WEIGHTS (PARENTAL ANIMALS)
No effects noted
GROSS PATHOLOGY (PARENTAL ANIMALS)
No effects noted
HISTOPATHOLOGY (PARENTAL ANIMALS)
No effects noted
OTHER FINDINGS (PARENTAL ANIMALS)
No effects noted
F2A and F2B – The various indices, litter size, pup body weights, appearance, and behavior of the newborn and of the pups during lactation were comparable among the control and test groups for both cycles. At birth, two pups from one high level F2A litter were found cold to the touch. Minor incidental findings were also noted.
Pre-implantation loss rates (%) were 14.4, 9.4, 14.3, and 9.8 at the 0, 125, 250, 500 mg/kg bw/day treatment groups, respectively.
Post-implantation loss rates (%) were 6.0, 6.0, 3.1, and 7.0.
- Estimation of mating data:
Mating rates (%) for the control group, 125, 250, 500 mg/kg bw/day treatment groups were 93.3, 86.7, 100, and 100, respectively.
Fertility rates (%) were 73.3, 80.0, 93.3, and 73.3 for male rats, and 78.6, 92.3 , 93.3, and 73.3 for female rats.
Parturition rates (%) were identical with the fertility rates for female animals.
- Pregnancy:
The period of pregnancy was 22.0, 22.1, 22.2, and 22.1 days for the control group, 125, 250, 500 mg/kg bw/day treatment groups, respectively.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data on toxicity to reproduction were available for the target substance Neodecanoic acid, iron salt. Therefore, data from suitable read-across partners Neodecanoic acid and Iron salts (iron sulphate heptahydrate, Iron dichloride) was used to assess the reproductive toxicity of Neodecanoic acid, iron salt.
In a three-generation reproduction study (equivalent to OECD 416), the effects of long-term ingestion of Neodecanoic acid on reproduction was evaluated in albino rats. Neodecanoic acid was administered in the diet at levels of 100, 500, and 1500 ppm fed to the rats through two parental and to two-litter filial generations. Following nine weeks of dietary administration to the F2B weanlings designated as the third parental generation, the study was terminated. There was no evidence at any test level of an adverse effect on the survival, appearance, behavior, body weight gain, and food consumption of the parental generations; on the reproductive performance of the parents reflected by the various indices; or on the growth, appearance, and behavior of the offspring. Gross and macroscopic pathological findings revealed no evidence of a compound-related effect at any of the dietary levels. Based on these results, the NOAEL (F0, F1 and F2) is considered to be greater than 1500 ppm.
In addition, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422), the test item iron dichloride (99.8% purity) was administered to male and female Sprague Dawley rats/dose by gavage at dose levels of 0, 125, 250 and 500 mg/kg bw/day. The animals were treated with the test item formulation on 7 days per week for a period of 42 days for males and 40 to 54 days for females. By the particular test results such as the reduced rate of body weight gain, increased water consumption, increased organ weights, effects seen in gross and histopathology, the NOAEL for parental toxicity was determined to be 125 mg/kg bw/day in males and 250 mg/kg bw/day in females (equivalent to 566 and 1131 mg/kg bw/day Neodecanoic acid, iron salt in males and females referring to the iron content, respectively). No adverse effects were seen on fertility and reproduction parameters. Thus, the NOAEL for reproductive/developmental toxicity can be considered to be 500 mg/kg bw/day (equivalent to 2248 mg/kg bw/day Neodecanoic acid, iron salt referring to the iron content, respectively).
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422), the test item Iron sulphate heptahydrate was administered to male and female CD(SD) rats by gavage at dose levels of 0, 30, 100, 300 and 1000 mg/kg bw/day. Based on the changes in urinalysis, hematological examinations, organ weight and histopathological findings in males and females, the NOAEL for maternal toxicity was determined to be 100 mg/kg bw/day in both sexes (equivalent to 205 mg/kg bw/day Neodecanoic acid, iron salt in males and females referring to the iron content, respectively). No adverse effects were seen on any reproductive or developmental toxicity parameters. Thus, the NOAEL for reproductive/developmental toxicity can be considered to be 1000 mg/kg bw/day (equivalent to 2049 mg/kg bw/day Neodecanoic acid, iron salt referring to the iron content, respectively).
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the target substance Neodecanoic acid, iron salt, does not warrant classification for reproductive/developmental toxicity.
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