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Diss Factsheets
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EC number: 455-600-9 | CAS number: 790240-84-5
- 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
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: Milli-Q-Water
- Details on mating procedure:
- the females were housed individually when daily vaginal smear was sperm positive or a copulation plug was observed;
- Details on analytical verification of doses or concentrations:
- the dose formulations were prepared weekly;
- Duration of treatment / exposure:
- males treated for 28 days; dams and pups on day 4 post partum; if birth did not occur the dam was sacrified on day 25 post coitum;
- Frequency of treatment:
- once daily
- Remarks:
- Doses / Concentrations:
10 ml/kg b.w.
Basis:
actual ingested - No. of animals per sex per dose:
- 40 males, 10 per group;
40 females, 10 per group - Parental animals: Observations and examinations:
- Viability/ Mortality: twice daily; clinical signs; food consumption; body weights;
- Litter observations:
- litter size, live birth, still birth and gross anomalies; sex ratio; body weights;
- Postmortem examinations (parental animals):
- males were sacrified after 28 days treatment: damps and pups were sacrified on day 4 post partum; all parent animals and pups were examined macroscopically; for the parent animals, special attention was directed at the organs of the reproductive system.
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Other effects:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on the discoloration of feces;
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- during the first 4 days post partum
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- during the first 4 days post partum
- Reproductive effects observed:
- not specified
- Conclusions:
- A valid screening study for reprotoxicity (OECD 421) with the stubstance registered is avaliable. All animals survived the scheduled study period. No indices of a general toxicity were observed during the entire study at any dose level. The reproduction and developmental parameters investigated within this study did not give any indication of any test item-related effect. Thus, the NOAEL for general toxicity was determined to be 1000 mg/kg/day , also is the NOAEL for developmental toxicity considered to be 1000mg/kg/day.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Study reliability of 1.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A valid screening study for toxicity to reproduction (OECD 421) with the substance registered is available. The substance registered proved to be not toxic to reproduction up to a dose level of 1000 mg/kg/day.
All animals survived the scheduled study period. No test item-related effects on the relevant reproductive data (mating performance, fertility, corpora lutea count, implantation rate and post-implantation loss, duration of gestation, litter size at first litter check or postnatal loss) were observed at any dose level.Short description of key information:
Substance registered is not reproduction toxic up to a dose level of 1000 mg/kg/day when applied orally.
Justification for selection of Effect on fertility via oral route:
The selected study was performed under GLP and in accordance with OECD TG 421. No other studies are available.
Effects on developmental toxicity
Description of key information
Substance registered is not reproduction toxic up to a dose level of 1000 mg/kg/day when applied orally.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP guideline study, Klimisch1
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
A valid screening study for toxicity to reproduction (OECD 421) performed with the substance registered, is available. The substance registered proved to be not toxic to reproduction up to a dose level of 1000 mg/kg/day when applied orally. No findings were noted in pups at first litter check or during the first 4 days post partum. Pups sex ratio was not affected by the treatment with the test item at any dose level. No effects were observed on pup body weights and body weight gain during the first four days post partum at any dose level. No findings were noted during macroscopic examination of pups at any dose level.
Justification for selection of Effect on developmental toxicity: via oral route:
The selected study was performed under GLP and in accordance with OECD TG 421. No other studies are available.
Justification for classification or non-classification
The registered substance proved to be not toxic to reproduction up to a dose level of 1000 mg/kg bw/d when orally applied, thus no classification of the test item is required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.