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EC number: 603-894-6 | CAS number: 135108-88-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: At this moment lead registrant did not receive the final report from the laboratory. Report will be available on beginning of June and endpoint summary will be updated immediately with the data from the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine
- EC Number:
- 603-894-6
- Cas Number:
- 135108-88-2
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- 2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine
- Test material form:
- liquid: viscous
- Details on test material:
- Mixed polycycloaliphatic amines
Best to be used by Jan 31st 2018
Batch 1485489
Constituent 1
- Specific details on test material used for the study:
- Copolymer of benzenamine and formaldehyde, hydrogenated, other names : Mixed Polycycloaliphatic Amines; MPCA ; Commercial name Ancamine 2168Batch number 1485489MANUFACTURE DATE 31.1. 2013EXPIRY DATE 31.1. 2018
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- SourceAnimal BreedingRCC Laboratories India Private LimitedGenome Valley, TurkapallyShameerpet (Mandal)Ranga Reddy DistrictHyderabad - 500 078IndiaRegistration Number1010/RO/bc/06/CPCSEABody weight when treatedFemale: 235.6 – 279.6 gWeight variation within groups did not exceeded ± 20% of mean body weightIdentificationBy unique cage number and individual animal numbers marked with an indelible marker pen on the tail. The animals were marked with permanent animal numbers towards the base of tail before the start of test item administration and refreshed weekly thereafter. The animals were marked with the temporary animal numbers on the tip of the tail at start of acclimatization. Foetuses were identified with tag.RandomizationAnimals were selected and grouped based on stratified randomization of body weights using Excel based computerized program.AcclimatizationUnder laboratory conditions for 12 days post veterinary examination. Only animals without any visible signs of illness were used for the study. Standard Laboratory ConditionsThe animal room was air-conditioned with adequate (above 10) air changes per hour (about 10 air changes). The experimental room was continuously monitored for temperature and relative humidity. The ranges for room tem¬pera¬ture and relative humidity were 20.2°C to 22.9°C and 50 to 64%, respectively. The animals were provided with a light cycle of 12 hours light and 12 hours dark.AccommodationDuring acclimatization and randomization period all animals were housed in groups of two in polycarbonate cages (approximate internal dimensions of 365 mm x 202 mm x 180 mm height) with corn cob bedding. After randomization, males and females were housed individually. During the mating phase, animals were housedon one male: one female basis within each dose group. After successful mating, the females were returned to their original cage and housed individually during gestation. Results of analyses for contaminants of corn cob will be archived at RCC Laboratories India Private Limited DietTeklad Certified Global 14% Protein Rodent Maintenance Diet (Lot Number: 2014C-012415MA) from Harlan Laboratories and Teklad Certified Global 14% Protein Rodent Maintenance Diet (Lot Number: 2014C-111215MA) from ENVIGO was provided ad libitum. Results of analyses for contaminants will be archived at RCC Laboratories India Private Limited.WaterAquaguard filtered tap water was provided ad libitum. Results of bacteriological, chemical and contaminant analyses will be archived at RCC Laboratories India Private Limited
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- Animals were exposed to following test levels0 mg/kg b.w.70 mg/kg b.w.140 mg/kg b.w.280 mg/kg b.w.Test material was administered at the volume of 10 ml/kg b.w.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of the dose formulations from one set per dose group was taken immediately after preparation once before commencement of dosing (i.e. on day 5 of gestation on day 11 of gestation and on day 19 of gestation (days were considered from first dosing of the group) for homogeneity (mean of homogeneity given as dose concentration). Analyses were performed by Analytical Chemistry Department, RCC Laboratories India Private Limited according to an analytical method provided by the sponsor.
- Details on mating procedure:
- Animals were paired on a one male: one female basis within each dose group, for a maximum period of fourteen days. Each female was examined for vaginal smear or the presence of a copulation plug in the vagina. The presence of sperm in the vaginal smear and/or vaginal plug was taken as positive evidence of mating (Day 0 of gestation).
- Duration of treatment / exposure:
- Dosing from Day 5 to day 19 of the gestation
- Frequency of treatment:
- Once a day
- Duration of test:
- 20 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 70 mg/kg bw/day (nominal)
- Dose / conc.:
- 140 mg/kg bw/day (nominal)
- Dose / conc.:
- 280 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 24 females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- PRETESTPretest was performed using 3 females. The three females were treated with the highest dose of 280 mg/kg/body weight for seven consecutive days to confirm the doses.MATINGAnimals were paired on a one male: one female basis within each dose group, for a maximum period of fourteen days. Each female was examined for vaginal smear or the presence of a copulation plug in the vagina. The presence of sperm in the vaginal smear and/or vaginal plug was taken as positive evidence of mating (Day 0 of gestation).
Examinations
- Maternal examinations:
- OBSERVATIONSClinical sign observations were recorded approximately at the same time(s) each day taking into consideration the peak period of anticipated effects post test item administration. The condition of the animals were recorded including mortality, pertinent behavioural changes, and all signs of overt toxicity.Mortality/ Viability: Twice dailyClinical Signs:Daily cage-side clinical observations-Acclimatization Period:Once daily- Treatment Period:Twice daily on initial 3 days after treatment; once daily thereafterBody Weights-Acclimatization Period:Once weekly- Premating:On first day of pairing and weekly thereafter - Gestation:On gestation day 0, 3, 5, 8, 11, 14, 17 and 20 Feed Consumption- Gestation:On gestation day 3, 5, 8, 11, 14, 17 and 20
- Ovaries and uterine content:
- On observation of vaginal smear, all female rats were confirmed to have mated and assumed to be pregnant. At necropsy 4 females each of control, low and high and 3 female rats of intermediate dose group were found to be non-pregnant. For consistency 20 pregnant females of each group were taken for evaluation/analysis. Gravid uteri including the cervix were weighed. The uteri of females were examined for the presence and number of implantation sites and the number of corpora lutea in the ovaries were determined for pregnant animals. The uterine content was examined for number of resorption, live and/or dead foetuses. The degree of resorption was described in order to estimate the relative time of death of the conceptus.
- Fetal examinations:
- EXTERNAL EXAMINATIONThe foetuses were removed, identified, weighed, sexed and evaluated for external malformation/variation. Foetuses were sacrificed by intraperitoneal injection of Thiopental sodium at approximately 200 mg/kg body weight. Each fetus was subject to external examination, which included all visible structures, surfaces and orifices (including the oral cavity). One-half of the fetuses (alternating foetuses within the litter) independent of sex were processed for skeletal alterations and remaining half of each litter were examined for visceral (soft tissue) alterations.VISCERAL (SOFT TISSUE) EXAMINATIONAll the foetuses selected for visceral examination were observed by Staple’s dissection technique for visceral malformations/alterations and discarded. All the organs and structures of the head, neck, thorax and abdomen were observed.SKELETAL EXAMINATIONAll the foetuses selected for skeletal examination were eviscerated, processed, stained with Alizarin red S (single staining) and examined for skeletal malformations/alterations by using stereomicroscope. All the bone structures of the head, spine, rib cage, pelvis and limbs were observed.
- Statistics:
- The following statistical methods were used to analyze the body weight, body weight change, feed consumption, reproduction and external, visceral and skeletal alterations/variations:Data was summarized in tabular form. Statistical analysis was performed using Statplus program. All the data was checked for Normality with Shapiro-Wilk W test and for Homogeneity with Bartlett Chi-Square test. Each group of animals was subjected to Analysis of Variance (ANOVA) among the groups, and Bonferroni Test for unequal replications. For discontinuous data, nonparametric test (Mann-Whitney U-Test) was used. Values are given as mean ± standard deviation (SD). P ≤ 0.05 (5% level of significance) was considered to represent significance in the respective parameters, P > 0.05 was considered not Significant.
- Indices:
- INDICES CALCULATIONSThe following formulae were used for calculating the indices: Pre–implantation loss (%)(Number of Corpora Lutea - number of implantation sites)/ Number of Corpora Lutea x100Post–implantation loss (%)(Number of implantation sites - Total number of live foetuses)/ Number of implantation sites x 100Sex Ratio (% males) Number of male foetuses (Day 0) / Total number of foetuses (Day 0) x 100Variation Incidence (%)Number of foetuses with variation/ Total Number of foetuses examined x100
- Historical control data:
- Will be provided when final report is available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- All the treated animals appeared normal and no systemic or local signs of toxicity were observed from day 0 and continued to be normal till the last day of observation, on day 20th of gestation. No clinical signs were observed in any of the female rats from control (0 mg/kg bw), low (70 mg/kg bw), intermediate (140 mg/kg bw) and high dose (280 mg/kg bw) groups.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was observed in any of the treated animals. All the female rats survived through out the scheduled treatment period.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant difference in the body weight and body weight gain (%) was observed in any of the pregnant female rats of low, intermediate and high dose groups when compared with control group animal.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Feed consumption of pregnant female animals of low, intermediate and high dose groups was not significantly different when compared with that of control group except between day 3 - 5 of gestation revealed significantly decreased feed consumption in low and high dose as compare to control group and between day 8 - 11 and 14 - 17 of gestation revealed significantly decreased feed consumption in low dose as compare to control group. These cannot be changes attributed to toxicity to the test item exposure.
- 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):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No abnormality was observed in any of the pregnant female animals from control, low, intermediate and high dose groups.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- The number of corpora lutea on the ovaries and implantation sites in uterus, and therefore the extent of pre-implantation loss and post-implantation loss in all treated groups were comparable with control group. There was no significant difference observed in early and late resorption and number of live foetuses in all tretment groups when compared with control group.
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- The number of corpora lutea on the ovaries and implantation sites in uterus, and therefore the extent of pre-implantation loss and post-implantation loss in all treated groups were comparable with control group. There was no significant difference observed in early and late resorption and number of live foetuses in all tretment groups when compared with control
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- ParameterGroupG1G2G3G4Dose (mg/kg bw)070140280No. of Dams20202020Gravid Uterine WeightMean55.0849.7053.9355.43SD17.5311.6615.6820.68Total Foetuses Number193189216211Mean4.033.443.583.51SD0.130.120.100.12No. of CLMean14.3813.6713.8315.13SD2.342.782.823.31No. of Implantation Mean9.138.889.759.38SD5.744.835.146.08Early Resorption Mean0.420.420.290.58SD0.650.780.460.83Late Resorption Mean0.040.080.000.00SD0.200.280.000.00Pre implantation loss mean5.254.714.085.75SD5.104.595.017.16%38.335.829.635.7Post implantation lossMean1.041.000.750.6SD1.201.530.901.6%10.710.67.810.3Dam with resorption/sNumber12111212
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- GroupG1G2G3G4Dose (mg/kg bw)070140280FEMALE ANIMALS MATED24242424PREGNANT FEMALE ANIMALS 20202120
- Other effects:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 280 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- changes in number of pregnant
- changes in pregnancy duration
- clinical signs
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- gross pathology
- maternal abnormalities
- mortality
- number of abortions
- organ weights and organ / body weight ratios
- pre and post implantation loss
- total litter losses by resorption
Maternal abnormalities
- Abnormalities:
- no effects observed
- Localisation:
- cervix
- uterus
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Group →G1G2G3G4Dose (mg/kg bw) 070140280No. of Dams →20202020Total No. of Foetuses 193189216211Mean Litter Size 8.047.889.399.17Live FoetusesNumber193189216211Mean8.047.889.008.79SD5.254.284.905.48
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): GroupFoetus Weight(G)Group 1Mean4.03SD0.13N193Group 2Mean3.44SD0.12N189Group 3Mean3.58SD0.10N216Group 4Mean3.51SD0.12N211 - Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- Group →G1G2G3G4Dose (mg/kg bw) 070140280No. of Dams →20202020Total No. of Foetuses 193189216211Mean Litter Size 8.047.889.399.17Live FoetusesNumber193189216211Mean8.047.889.008.79SD5.254.284.905.48
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- Group/DoseMale%Female%Group 139.9660.04Group 247.0352.97Group 354.0945.91Group 451.5948.41
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- Six small sized foetuses were observed in control, four in low, three in intermediate and one in high dose group.
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- External examination of foetuses revealed dome shaped head in one foetus each of control and low dose group. Short snout was observed in one foetus of low dose group. In intermediate dose group reddish discolouration of body was observed in one foetus. While pale body was observed in one foetus in high dose group.No significant difference was observed in external findings in all treatment groups when compared with control group.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- Skeletal examination of high dose group foetuses revealed incompletely ossified interperital, sacral, sternal centers (1 and 2), manubrium and/or Xyphiod; not ossified sternal centers (1 and 2), manubrium and/or Xyphiod; small sized pubis, scapula, humerus, radius, ulna, ilium, ischium, femur, tibia and/or fibula; Dumbbell shaped thoracic and lumbar vertebrae and thin ribs and clavicles. Intermediate dose group revealed incompletely ossified nasal (left and right), premaxilla, frontal, parietal, maxilla, mandible, zygomatic, sphenoid ala, hyoid, sphenoid body, pterygoid process, cervical, thoracic, lumbar vertebrae, sternal centers (1 and 2 manubrium, Xyphiod, clavicle, scapula, humerus, radius, ulna, ilium, femur, tibia and/or fibula; not ossified bascioccipita, interperital, supraoccipital, hyoid, sternal centers (1), manubrium, Xyphiod, ischium and/or pubis; Dumbbell shaped thoracic and lumbar vertebrae; hemivertebrae in lumbar; waviness of ribs; short tail and small sized eye socket, brain case, nasal, premaxilla, frontal, parietal, maxilla, mandible, tympanic ring, lumbar, clavicle, scapula, forelimb, humerus, radius, ulna, ilium, hind limb, femur, tibia and/or fibula.Low dose group revealed incompletely ossified interperital, sternal centers (1 and 2), manubrium, Xyphiod and/or pubis; not ossified sternal centers (1), manubrium, Xyphiod and/or pubis; Dumbbell shaped thoracic and/or sternal centers (1) and small sized scapula.Control group revealed incompletely ossified sternal centers (1 and 2), manubrium, Xyphiod; not ossified sternal centers (1) and/or Xyphiod; Dumbbell shaped thoracic vertebrae; fused sternal centers (1) and manubrium and short ischium.These variations observed in high, intermediate and low dose groups were isolated and when expressed on a fetus/litter basis, it was found to be not statistically significant when compared with incidence in control group. Type and distribution of variations noted during skeletal examination at the dose levels of 70, 140 and 280 mg/kg body weight did not indicate any test item-related effects.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- Visceral examination of foetuses revealed convoluted ureter in four foetuses of control group and three foetuses each in intermediate and high dose groups. Small sized spleen was observed in one foetus each of control, intermediate and high dose group and two foetuses in low dose group. Dilated ventricles of brain was observed in two foetuses in control and one foetus each of low and high dose groups. Pale spleen was observed in 1 foetus each of control, low and intermediate and 2 foetuses of high dose group.No significant difference was observed in visceral findings in all treatment groups when compared with control group.
- Other effects:
- not examined
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 280 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- external malformations
- skeletal malformations
- visceral malformations
Fetal abnormalities
open allclose all
- Abnormalities:
- not specified
- Abnormalities:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were observed in reproduction parameters such as litter weight, foetus weight, corpora lutea count, early and late resorption and number of live and dead foetuses, pre-implantation loss, post-implantation loss as well as sex ratio at any dose level in the female animals treated with 70, 140 and 280 mg/kg body weight/day. The external and visceral variations observed in foetus were randomly distributed across the groups. Therefore these findings were considered as incidental findings and not test item-related.
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the OECD 414 study findings it is concluded that the test item is non teratogenic in rats and the NOAEL for teratogenicity of the test item can be fixed as 280 mg/kg bw/day, under the present experimental conditions. The NOAEL for maternal toxicity was determined to be 280 mg/kg bw/day.
- Executive summary:
The test item, copolymer of benzenamine and formaldehyde, hydrogenated refined groundnut oil (Arachis oil) was administered once daily by oral gavage to three treatment groups of twenty four pregnant female Wistar rats each from day 5 to day 19 of gestation at dose levels of 70, 140 and 280 mg/kg body weight/day. A control group of twenty four females were administered with vehicle (refined groundnut oil) alone.The treatment with test item resulted in no mortalities. All the dams survived till the scheduled sacrifice.No test item related clinical signs were observed in any of the pregnant female animals of low, intermediate and high dose groups as well as in control group. The body weight, body weight gain (%) and feed consumption during gestation period in all treatment groups were comparable with control group.No treatment-related effects were observed in reproduction parameters such as litter weight, foetus weight, corpora lutea count, early and late resorption and number of live and dead foetuses, pre-implantation loss, post-implantation loss as well as sex ratio at any dose level in the female animals treated with 70, 140 and 280 mg/kg body weight/day. The external and visceral variations observed in foetus were randomly distributed across the groups. Therefore these findings were considered as incidental findings and not test item-related.Type and distribution of variations noted during skeletal examination at the dose levels of 70, 140 and 280 mg/kg body weight/day did not indicate any test item-related effects. Based on the above findings, it is considered that the test item is non teratogenic in rats and the NOAEL for teratogenicity of the test item can be fixed as 280 mg/kg bw/day, under the present experimental conditions. The NOAEL for maternal toxicity was considered as 280 mg/kg bw/day.
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