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EC number: 231-679-3 | CAS number: 7681-82-5
- 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
Reproductive Toxicity Study:
A study was conducted with rats to determine the effects of intake of the test chemical. A total of 27 animals were used in this study. Females were bred to normal males, wherein the test chemical was added to the diet during the latter portion of gestation and the females were permitted to litter normally. The effect of the treatment on gestation period, lactation and survival of the young was observed.It was observed that, gestation time for rats was not affected ; however, prolonged parturition was observed in rats. In fetal parameters, average mortality was slightly greater of young from those fed with the test chemical, while the weaning weight was significantly less than that of controls.In other experiment, the female rats were re-bred after removal of dietary intake of the test chemical. It was observed that the females gave birth and nursed litters normally. Thus, from all the oabove observations,LOAEL was found to be 150 mg/kg bw andit is likely to be regarded that there is no reproductive toxicity at concentrations lower than 150 mg/kg bwwhen administered orally.
Link to relevant study records
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from a publication.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 414: Pre-Natal Developmental toxicity screening test.
- Principles of method if other than guideline:
- The above experiment was performed to assess and evaluate the effects of the test chemical on Long-Evans rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No Data Available
- Specific details on test material used for the study:
- - Molecular weight (if other than submission substance): 149.89427 g/mol
- Substance type: Inorganic
- Physical state: Solid
- Impurities (identity and concentrations): N/A - Species:
- rat
- Strain:
- Long-Evans
- Details on species / strain selection:
- No Data Available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Housing: Animals were housed individually in wire cages. Prior to littering, rats were transferred to 3 X 3 mesh wire cages.
- Diet (e.g. ad libitum): Purina Laboratory Chow were provided ad libitum
- Water (e.g. ad libitum): Tap water was supplied ad libitum - Route of administration:
- oral: feed
- Vehicle:
- other: Diet as Purina Laboratory Chow
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: The test chemical was administered through diet.
DIET PREPARATION
- Rate of preparation of diet (frequency): Daily
- Mixing appropriate amounts with (Type of food): No Data Available
- Storage temperature of food: No Data Available
VEHICLE
- Justification for use and choice of vehicle (if other than water): The test chemical was best miscible in corn oil.
- Concentration in vehicle: 0, 2500 ppm (150 mg/kg bw)
- Amount of vehicle (if gavage): No Data Available
- Lot/batch no. (if required): No Data Available
- Purity: No Data Available - Details on mating procedure:
- - The sexually mature females were bred to normal males of the breed or strain. Monogamous pairs of rats were mated. When breeding occurred, the time of first copulation was recorded and gestation subsequently calculated from this time to birth of the first young of the litter. Fourteen female rats which had been fed the test chemical and had produced but lost all young in one or more litters were subsequently re-bred after removal from dietary iodine.
- After successful mating each pregnant female was caged (how): Individually - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Duration of treatment / exposure:
- 12 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- No Data Available
- Remarks:
- Doses / Concentrations:
0 and 150 mg/kg bw (2500 ppm)
Basis:
Nominal in diet - No. of animals per sex per dose:
- 27 female rats were used
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - F1 parental animals not mated until weeks after selected from the F1 litters: No Data Available
- Selection of parents from F1 generation when pups were [...] days of age: No Data Available
- Age at mating of the mated animals in the study: No Data Available - Positive control:
- No Data Available
- Parental animals: Observations and examinations:
- Observations were made for length of parturition time and number of young born dead and those born live. Periodic observations were made through the lactation period for mothering instinct, evidence of lactation .
- Oestrous cyclicity (parental animals):
- No Data Available
- Sperm parameters (parental animals):
- No Data Available
- Litter observations:
- Survival of young animals was observed.
- Postmortem examinations (parental animals):
- No Data Available
- Postmortem examinations (offspring):
- No Data Available
- Statistics:
- The data was subjected to statistical analysis. The analytical methods included Analysis of Variance (ANOVA).
- Reproductive indices:
- No Data Available
- Offspring viability indices:
- Pups Viability Index.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Voluntary feed intake of rats fed with the test chemical was about 6 to 7% less than that of control rats and this reduced feed intake
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- REPRODUCTIVE PERFORMANCE: Gestation time for rats was not affected by the test chemical; however, prolonged parturition was observed in rats.No signs of the beginning of lactation were observed.
- Dose descriptor:
- LOAEL
- Effect level:
- 150 other: mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Effects observed on the following parameters : Gestation time, Parturition and No signs of the beginning of lactation were observed.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Average mortality was slightly greater of young from those fed with the test chemical.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Weaning weight was significantly less than that of controls.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 150 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- Remarks on result:
- other: Not Specified
- Critical effects observed:
- not specified
- System:
- other: Not Specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- The LOAEL value of orally administered test chemical in Long-Evans rats was determined to be 150mg/kg bw.
- Executive summary:
A study was conducted with rats to determine the effects of intake of the test chemical. A total of 27 animals were used in this study. Females were bred to normal males, wherein the test chemical was added to the diet during the latter portion of gestation and the females were permitted to litter normally. The effect of the treatment on gestation period, lactation and survival of the young was observed. It was observed that, gestation time for rats was not affected ; however, prolonged parturition was observed in rats. In fetal parameters, average mortality was slightly greater of young from those fed with the test chemical, while the weaning weight was significantly less than that of controls. In other experiment, the female rats were re-bred after removal of dietary intake of the test chemical. It was observed that the females gave birth and nursed litters normally. Thus, from all the oabove observations, LOAEL was found to be 150 mg/kg bw and it is likely to be regarded that there is no reproductive toxicity at concentrations lower than 150 mg/kg bw when administered orally.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The data is from a Klimisch 2 database.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity study:
Data available from different studies were reviewed to determine the reproductive toxicity of testchemical.The studies are as mentioned below:
Reproductive Toxicity Study 1:
A study was conducted with rats to determine the effects of intake of the test chemical. A total of 27 animals were used in this study. Females were bred to normal males, wherein the test chemical was added to the diet during the latter portion of gestation and the females were permitted to litter normally. The effect of the treatment on gestation period, lactation and survival of the young was observed.It was observed that, gestation time for rats was not affected ; however, prolonged parturition was observed in rats. In fetal parameters, average mortality was slightly greater of young from those fed with the test chemical, while the weaning weight was
significantly less than that of controls.In other experiment, the female rats were re-bred after removal of dietary intake of the test chemical. It was observed that the females gave birth and nursed litters normally. Thus, from all the oabove observations,LOAEL was found to be150 mg/kg bw andit is likely to be regarded that there is no reproductive toxicity at concentrations lower than150 mg/kg bw when administered orally.
Reproductive Toxicity Study 2:
The effect of the test chemical on the reproductive performance of female minks was investigated.Female minks were administered with 0, 10, 100, or 1000 ppm of the test chemical, in diet for 18 days, from breeding through lactation. A total of 60 animals were used in the study. The animals were grouped in to 4 test groups 10 animals per group. The test animals were observed for , In litter observations, the kits were counted, weighed and sexed. From all the observations, it was found that, the gestation periods of the test chemical-treated mink were shorter than the controls. Kit birth weights were not significantly different from the controls. The average number of kits whelped per female mated in the control group was 5.0. Only 2.1 kits per female mated were whelped by the mink fed 100 ppm supplemental test chemical and none of the females that received the 1000 ppm supplemental test chemical diet whelped. Body weights of kits whelped and nursed by the females that received the 100 ppm supplemental test chemical diet were significantly lighter at 4 weeks of age.No detrimental effects were observed on litter size or kit survival in the group fed 10 ppm supplemental test chemical, and hence the NOAEL for reproductive toxicity in female minks is determined to be 10 ppm of the test chemical in the diet.
Reproductive Toxicity Study 3:
The above experiment was performed to study the effect of ingestion of the test chemical by parental examinations on the behavioural competence of developing animals is studied.The test chemicalwas administered in diet to male and female Sprague-Dawley rats before and during breeding, to females only during gestation and lactation, at levels of 0, about 23,45 and 90 mg/kg bw [0, 0.025, 0.05 or 0.1% (w/w)]. Dams in a positive control group were given 4 mg/kg ip of the anti-mitotic/cytotoxic drug 5-azacytidine on day 17 of gestation.The LOAEL value for the test chemical in rats is found to be about 90 mg/kg/day (0.1%). At this dose level, the test chemical did not produce any significant reduction in parental body weight or food consumption, though it significantly reduced litter size and increased offspring mortality.The LOAEL value for the test chemical is found to be about 45 mg/kg/day (0.05%) for the F1 generation based on the effect of decreased pre-weaning body weights in the offspring, delay in auditory startle and delayed olfactory orientation from the home-cage scent.Overall, the data in this experiment support the view that the test chemical at doses of up to 0.1% in the diet of growing rats produces evidence of developmental toxicity.
Reproductive Toxicity Study 4:
In a one-generation (experiment I) and fertility (experiment II) reproductive study, pregnant female Wistar rats were given fluid orally on a regular basis at dose levels of 0.1% (w/v) or 1% (w/v) of the test chemical.Treatment with 1% (w/v) solution led to reduced body weight and fluid intake, their adrenal glands were enlarged and the level of implementation was prevented. No change in food or fluid intake was seen for rats treated with 0.1% (w/v) solution. In addition, the 0.1% (w/v) of the test chemical solution-treated rats showed a high rate of implantation.Since 0.1% (w/v) of the test chemical is regarded as a high value intake and it is concluded that the test chemical has no effect on reproductive toxicity when orally administered. Neither has it provided any further information about the possible functional significance of the test chemical endometrial concentration in female rats during early pregnancy.
Effects on developmental toxicity
Description of key information
Developmental toxicity study:
A study was conducted with rats to determine the effects of intake of the test chemical. A total of 27 animals were used in this study. Females were bred to normal males, wherein the test chemical was added to the diet during the latter portion of gestation and the females were permitted to litter normally. The effect of the treatment on gestation period, lactation and survival of the young was observed.It was observed that, gestation time for rats was not affected ; however, prolonged parturition was observed in rats. In fetal parameters, average mortality was slightly greater of young from those fed with the test chemical, while the weaning weight was significantly less than that of controls.In other experiment, the female rats were re-bred after removal of dietary intake of the test chemical. It was observed that the females gave birth and nursed litters normally. Thus, from all the oabove observations, LOAEL was found to be150 mg/kg bw and it is likely to be regarded that there is no reproductive and developmental toxicity at concentrations lower than150 mg/kg bwwhen administered orally.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from a publication.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- The above experiment was conducted to evaluate and assess the effects of the test chemical on the developmental parameters of the Long-Evans Rats.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Molecular weight (if other than submission substance):149.89427
- Substance type:Inorganic
- Physical state:Solid - Species:
- rat
- Strain:
- Long-Evans
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Housing:Animals were housed individually in wire cages. Prior to littering, rats were transferred to 3 X 3 mesh wire cages.
- Diet (e.g. ad libitum):Purina Laboratory Chow were provided ad libitum
- Water (e.g. ad libitum):Tap water was supplied ad libitum - Route of administration:
- oral: feed
- Vehicle:
- other: Diet as Purina Laboratory Chow
- Details on exposure:
- No Data Available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Details on mating procedure:
- - The sexually mature females were bred to normal males of the breed or strain.
- Monogamous pairs of rats were mated. When breeding occurred, the time of first copulation was recorded and gestation subsequently calculated from this time to birth of the first young of the litter. Fourteen female rats which had been fed with the test chemical and had produced but lost all young in one or more litters were subsequently re-bred after removal of the test chemical
- After successful mating each pregnant female was caged (how): Individually - Duration of treatment / exposure:
- 12 days
- Frequency of treatment:
- Daily
- Duration of test:
- From breeding to day 21 of suckling
- Remarks:
- Doses / Concentrations:
0,150 mg/kg bw (2500 ppm)
Basis: - No. of animals per sex per dose:
- 27 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No Data Available
- Maternal examinations:
- Observations were made for length of parturition time and number of young born dead and those born live. Periodic observations were made through the lactation period for mothering instinct, evidence of lactation and survival of young.
- Ovaries and uterine content:
- No Data Available
- Fetal examinations:
- All surviving young from each female in the control and experimental groups were permitted to nurse through the normal suckling period.
- Statistics:
- The statistical data was analyzed by using Analysis of Variance (ANOVA).
- Indices:
- Pups Viability Index.
- Historical control data:
- No Data Available
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Voluntary feed intake of rats fed with the test chemical was about 6 to 7% less than that of control rats and this reduced feed intake
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- effects observed, treatment-related
- Description (incidence and severity):
- An increased incidence of death in the neonates, with <10% of the young surviving for 3 days.
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Gestation time for rats was not affected by the test chemical.
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.DescriptionIncidenceAndSeverityEffectsOnPregnancyDuration): Gestation time for rats was not affected by the test chemical. - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Prolonged parturition was observed in rats.No signs of the beginning of lactation were observed.
- Dose descriptor:
- LOAEL
- Effect level:
- 150 other: mg/kg bw
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Abnormalities:
- not specified
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Weaning weight was significantly less than that of controls.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Survival of the young and body weights at weaning were equal to those of controls. - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- LOAEL
- Effect level:
- 150 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Based on all the observations, it was concluded that the LOAEL for the test chemical was found to be 150 mg/kg bw after analyzing the effects on developmental parameters of the Long-Evans Rats.
- Executive summary:
A study was conducted with rats to determine the effects of intake of the test chemical. A total of 27 animals were used in this study. Females were bred to normal males, wherein the test chemical was added to the diet during the latter portion of gestation and the females were permitted to litter normally. The effect of the treatment on gestation period, lactation and survival of the young was observed.It was observed that, gestation time for rats was not affected ; however, prolonged parturition was observed in rats. In fetal parameters, average mortality was slightly greater of young from those fed with the test chemical, while the weaning weight was significantly less than that of controls.In other experiment, the female rats were re-bred after removal of dietary intake of the test chemical. It was observed that the females gave birth and nursed litters normally. Thus, from all the above observations,LOAEL was found to be150 mg/kg bw and it is likely to be regarded that there is no reproductive and developmental toxicity at concentrations lower than150 mg/kg bw when administered orally.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LOAEL
- 150 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Developmental toxicity study:
Data available from different studies were reviewed to determine the developmental toxicity of test chemical.The studies are as mentioned below:
Developmental Toxicity Study 1:
A study was conducted with rats to determine the effects of intake of the test chemical. A total of 27 animals were used in this study. Females were bred to normal males, wherein the test chemical was added to the diet during the latter portion of gestation and the females were permitted to litter normally. The effect of the treatment on gestation period, lactation and survival of the young was observed.It was observed that, gestation time for rats was not affected ; however, prolonged parturition was observed in rats. In fetal parameters, average mortality was slightly greater of young from those fed with the test chemical, while the weaning weight was significantly less than that of controls.In other experiment, the female rats were re-bred after removal of dietary intake of the test chemical. It was observed that the females gave birth and nursed litters normally. Thus, from all the above observations,LOAEL was found to be150 mg/kg bw andit is likely to be regarded that there is no reproductive and developmental toxicity at concentrations lower than150 mg/kg bwwhen administered orally.
Developmental Toxicity Study 2:
The above experiment was performed to study the effect of ingestion of the test chemical by parental examinations on the behavioural competence of developing animals is studied.The test chemicalwas administered in diet to male and female Sprague-Dawley rats before and during breeding, to females only during gestation and lactation, at levels of 0, about 23,45 and 90 mg/kg bw [0, 0.025, 0.05 or 0.1% (w/w)]. Dams in a positive control group were given 4 mg/kg ip of the anti-mitotic/cytotoxic drug 5-azacytidine on day 17 of gestation.The LOAEL value for the test chemical in rats is found to be about 90 mg/kg/day (0.1%). At this dose level, the test chemical did not produce any significant reduction in parental body weight or food consumption, though it significantly reduced litter size and increased offspring mortality.The LOAEL value for the test chemical is found to be about 45 mg/kg/day (0.05%) for the F1 generation based on the effect of decreased pre-weaning body weights in the offspring, delay in auditory startle and delayed olfactory orientation from the home-cage scent.Overall, the data in this experiment support the view that the test chemical at doses of up to 0.1% in the diet of growing rats produces evidence of developmental toxicity.
Developmental Toxicity Study 3:
A one-generation study was conducted on Syrian hamsters to determine the effects of excess of the test chemical intake.Females were bred with normal males while the test chemical (2500 ppm per day or 160 mg/kg bw) was added to their diet during the latter portion of gestation and the females were permitted to litter normally. The effect of the treatment on gestation period, lactation and survival of the young was observed. After all the observations were performed, it was found that, in maternal animals, the mortality among nursing hamsters from females fed with the test chemical was high. Also, voluntary feed intake of the diets containing added test chemical by the pregnant and lactating hamsters was approximately 10% less than that of the controls. However, these cases were considered as sporadic. In fetal parameters, mortality of the young was high but approximately equal in both the experimental and control groups, however, the cause of high mortality is not known. In some cases, some cases of “wet tail” and evidence of dehydration were observed in both control and treated animals.Since there was an absence of specific effects upon reproduction and lactation in pregnant female hamsters, or no increased levels of mortality of the young compared to control, NOAEL of both the parental generation and the F1 generation was considered to be 2500 ppm per day of the test chemical.
Justification for classification or non-classification
From data of all the above studies, the test chemical does not exhibit toxicity to the reproductive system as well as developmental toxicity within the doses mentioned in the various end points.
Additional information
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