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EC number: 203-039-3 | CAS number: 102-54-5
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- Body wt.range stated 180-200g. Actual-males(269-309g), females(193-221g). The target range for RH (50 ± 20%), achieved range was 39- 86%. Neither deviation from Study Plan was considered to have had no impact on the scientific integrity of the study
- Principles of method if other than guideline:
- DEVIATIONS FROM STUDY PLAN
The predicted body weight range stated in the Study Plan at the start of treatment was 180-200 g, but this range proved to be too low for the age of animals required. At the start of treatment, males weighed 269 to 309g and females weighed 193 to 221g; all were of the correct age and were considered acceptable for the study. The deviation from Study Plan for the weight ranges for these animals was considered to have had no impact on the scientific integrity of the study.
The Study Plan target range for relative humidity was 50 ± 20% respectively but this was exceeded on a number of occasions during the study (achieved range was 39- 86% RH). While the deviations observed for relative humidity were not ideal, it was considered that they had not impacted on the scientific integrity of the study. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ferrocene
- EC Number:
- 203-039-3
- EC Name:
- Ferrocene
- Cas Number:
- 102-54-5
- Molecular formula:
- C10H10Fe
- IUPAC Name:
- iron(2+) dicyclopenta-2,4-dienide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Description : Orange coloured crystalline
Chemical name : Dicyclopentadienyl Iron
CAS number : 102-54-5
Storage conditions : room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Han™:RccHan™:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Number: 80, (40 males and 40 females)
- Source: Harlan Laboratories U.K. Ltd., Blackthorn, Bicester, Oxon, UK.
- Age at study initiation: (P) 10 wks
- Weight at study initiation: (P) Males: 269-309 g; Females: 193-221 g (see Deviations from Study Plan)
- Housing: Initially, all animals were housed in groups of five in solid floor polypropylene cages with stainless steel mesh lids and softwood flake bedding (Datesand Ltd., Cheshire, UK). During the pairing phase, animals were transferred to polypropylene grid floor cages suspended over trays lined with absorbent paper on a one male: one female basis within each dose group. Following evidence of successful mating, the males were returned to their original cages. Mated females were housed individually during gestation and lactation, in solid floor polypropylene cages with stainless steel mesh lids and softwood flakes.
- Diet: ad libitu, Pelleted, Rodent 2018C Teklad Global Certified Diet, Harlan Laboratories U.K. Ltd., Oxon, UK
- Water: ad libitum, mains drinking water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 2-+3
- Humidity (%): 39-86 - it was considered that this had not impacted on the scientific integrity of the study (see Deviation from Study Plan).
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- i) Groups of ten male and ten female animals were treated daily at the appropriate dose level throughout the study (except for females during parturition where applicable). The first day of dosing was designated as Day 1 of the study.
ii) Prior to the start of treatment and once weekly thereafter, all animals were observed for signs of functional/behavioural toxicity.
iii) On Day 15, animals were paired on a 1 male: 1 female basis within each dose group for a maximum of fourteen days. - Details on mating procedure:
- Animals were paired on a 1 male: 1 female basis within each dose group, for a period of up to fourteen days. Cage tray-liners were checked each morning for the presence of ejected copulation plugs and each female was examined for the presence of a copulation plug in the vagina. A vaginal smear was prepared for each female and the stage of oestrus or the presence of sperm was recorded. The presence of sperm within the vaginal smear and/or vaginal plug in situ was taken as positive evidence of mating (Day 0 of gestation) and the males were subsequently returned to their original holding cages (unless required for additional pairing). Mated females were housed individually during the period of gestation and lactation.
- Duration of treatment / exposure:
- 28days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 10 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 15 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- Several observations were made. Parameters included:
Clinical Observations
Functional Observations-Behavioural Assessments, Functional Performance Tests; Motor Activity.and Forelimb/Hindlimb Grip Strength., Sensory Reactivity
Body Weight
Food Consumption
Water Consumption
Reproduction Screening-Mating, Pregnancy and Parturition, Litter Data, Physical Development
Laboratory Investigations-Haematology, Blood Chemistry
Pathology-Organ Weights, Histopathology - Litter observations:
- The standard unit of assessment was considered to be the litter, therefore values were first calculated for each litter and the group mean was calculated using the individual litter values. Group mean values generally included all litters reared to termination (Day 5 of age), however at 25 mg/kg bw/day group mean values were calculated for all pregnant animals (where appropriate) and also for those females that littered.
- Statistics:
- Where considered appropriate, quantitative data was subjected to statistical analysis to detect the significance of intergroup differences from control; statistical significance was achieved at a level of p<0.05.
- Reproductive indices:
- Mating Performance and Fertility
The following parameters were calculated from the individual data during the mating period of the parental generation:
i) Pre-coital Interval
ii) Fertility Indices
Gestation and Parturition Data
The following parameters were calculated for individual data during the gestation and parturition period of the parental generation.
i) Gestation Length
ii) Parturition Index
Litter Responses
The standard unit of assessment was considered to be the litter, therefore values were first calculated for each litter and the group mean was calculated using the individual litter values. Group mean values generally included all litters reared to termination (Day 5 of age), however at 25 mg/kg bw/day group mean values were calculated for all pregnant animals (where appropriate) and also for those females that littered.
i) Implantation Losses (%)
ii) Live Birth and Viability Indices
iii) Sex Ratio (% males)
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The clinical signs observed on the study were unremarkable and did not indicate any adverse effect of treatment at 5, 10 or 25 mg/kg bw/day.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Both had effects see discussion
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Both had effects see discussion
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Description (incidence and severity):
- There were no clear effects of treatment on fertility at 5,10 mg/kg bw/day. However, at 5, 10 mg/kg bw/day, 1 female had implantations but was not observed to litter; additionally at both dosages, 1 female showed total litter loss post partum
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Mating performance, as assessed by pre-coital interval and the evidence of mating observed (copulation plugs, sperm in the vagina), was unaffected by treatment at 5, 10 and 25 mg/kg bw/day.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 5 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: reproduction and offspring survival, growth and development
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: Reproduction and systemic toxicity
Results: F1 generation
Effect levels (F1)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 10 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: systemic toxicity
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 5 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: offspring survival, growth and development
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Ferrocene was assessed to investigate the systemic toxicity and its potential adverse effects on reproduction (including offspring development). the study was performed according to OECD Guideline 422.
There were clear treatment-related effects on reproduction at 25 mg/kg bw/day. At 5 and 10 mg/kg bw/day, reproduction per se was not affected by treatment but at both dosage two females failed to maintain their litter to Day 4 of age due to either in utero or post partum offspring losses. Very high pre and post natal losses were evident at 25 mg/kg bw/day, therefore the litter deaths at lower dosages become problematic when establishing a NOEL effect level for offspring survival, which may become clearer in a study of larger dimensions. Within the context of this study, there was no evidence of effects of treatment on surviving offspring at 5 mg/kg bw/day, although there was a suggestion of marginally lower weight gain at 10 mg/kg bw/day.
As effects of treatment were apparent at dosages as low as 5 mg/kg bw/day it was not possible to establish a No Observed Effect Level (NOEL) for systemic toxicity. A dosage of 10 mg/kg bw/day was considered to be a No Observed Adverse Effect Level (NOAEL) for systemic toxicity. In view of this the NOEL for reproduction and offspring survival, growth and development was considered to be at 5 mg/kg bw/day.
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