Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 269-348-0 | CAS number: 68227-33-8
- 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:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC
- Remarks:
- Doses / Concentrations:
50 mg/kg/day
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
100 mg/kg/day
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
200 mg/kg/day
Basis:
nominal in diet - No. of animals per sex per dose:
- 10 animals per sex and dose
- Control animals:
- yes, plain diet
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The clinical observations detected during this study were not considered to be related to systemic toxicity.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No adverse effect on bodyweight development or bodyweight gain was detected.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No adverse effect on bodyweight development or bodyweight gain was detected.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histopathogical examinations revealed the following treatment-related effect:
- Other effects:
- no effects observed
- Description (incidence and severity):
- Test substance intake: No adverse effect on bodyweight development or bodyweight gain was detected.
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were detected in the length of gestation.
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were detected in mating performance or fertility.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were detected in mating performance or fertility.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No significant differences were detected in litter sizes, sex ratio and viability for treated groups when compared to controls.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
- Sexual maturation:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- sexual maturation
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- gross pathology
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Conclusions:
- No treatment-related effects were detected in the reproductive parameters measured, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 125 mg/kg/day.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 125 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Study according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods. Klimisch rating = 1
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
Description of key information
No treatment-related effects were detected in the reproductive parameters measured,
therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 125 mg/kg/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
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
According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.7 this substance is not causing concern to be toxic to reproduction.
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.