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EC number: 218-746-2 | CAS number: 2224-15-9
- 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
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- Adopted: 22 March 1996
- GLP compliance:
- yes
- Remarks:
- Japan Existing Chemical Data Base: All the tests reported were performed in accordance with the chemicals GLP under the Law concerning Examination and Regulation of Manufacture, etc. of Chemical Substances and also meet the requirements of the OECD GLP.
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- water for injection
- Frequency of treatment:
- 1x / day
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 12.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Control animals:
- yes, concurrent vehicle
- Mortality:
- no mortality observed
- Ophthalmological findings:
- not examined
- Immunological findings:
- not examined
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- 200 mg/kg: no pregnant females
50 mg/kg:
- fertility index ((number of pregnant females/number of pairs with succesful copulation) x 100) = 58.3%
- corpora lutea decrease
- implantation index (number of implantation scars / number of corpora lutea) = 28.5% - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 12.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- 50 mg/kg: viability index (number of live pups on day 4 of lactation / number of live pups born) = 68.8% => only 12 pups, relevance 3 mortalities is unclear
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 50 mg/kg: body weight pups increased but normal since only limited number of pups per dam at this dose
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- - No external abnormalities
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 12.5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- mortality
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects occurring together with other toxic effects, but not as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- yes
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 12.5 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- 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
Justification for classification or non-classification
No pregnant females were observed at 200 mg/kg in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening study. The fertility index (number of pregnant females/number of pairs with successful copulation), number of corpora lutea, implantation scars and implantation index were all significantly lower at 50 mg/kg. The observed pre-implantation loss could result from an adverse effect on gamete transport or function, resulting in failed fertilisation, or it can be a consequence of direct effects on the preimplantation embryo or indirect effects on the uterus or endocrine status of the dam.
At the dose level of 50 mg/kg only slight systemic toxicity is observed in the male and female parent animals. Therefore the substance is classified Repr. 1B.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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