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EC number: 221-088-9 | CAS number: 3001-98-7
- 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
Description of key information
NOAEL = 1000 mg/kg/day (OECD 422)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EPA OPPTS 870.3650 (2000)*
- Version / remarks:
- *Note: The study design is similar to OPPTS 870.3650 design, but pups will be kept longer and additional endpoints will
be measured. - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Crl:WI rats
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days a week
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- 20 mg/mL, dose volume 5 mL/kg bw
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- 60 mg/mL, dose volume 5 mL/kg bw
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- 200 mg/mL, dose volume 5 mL/kg bw
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
- Positive control:
- none
- Clinical signs:
- effects observed, non-treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- No endocrine disruptor effect of test item was observed in the study based on the results of thyroid hormone analysis and thyroid gland weights.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- dermal irritation
- food consumption and compound intake
- gross pathology
- haematology
- immunology
- mortality
- neuropathology
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- water consumption and compound intake
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Critical effects observed:
- no
- Conclusions:
- Daily administration of the test item by oral gavage to Wistar rats at dose levels of 100, 300 or 1000 mg/kg bw/day (Low, Mid and High dose levels, respectively) during the treatment period under the conditions of this study did not result in test item related mortality, clinical signs, or effects on body weight or body weight gain, food consumption, haematology, coagulation, clinical chemistry or urinalysis parameters.
No test item related effect was detected during neurotoxicity assessment. In case of decreased motor activity results in High dose females, based on the historical control data, shape of the curve, lack of similar results in High dose males and lack of similar indication in the other tests, the observed data were considered as animal variability and not related to the test item treatment.
No test item-related macroscopic findings were recorded in any of the dose groups at necropsy; no microscopic effects were seen at histopathology. There were no test-item related differences among groups in the weights of organs measured when compared to controls.
No test item effect on oestrus cycle of parental females were was noted.
No test item related changes were noted in the reproductive parameters, gestation, parturition and lactation.
There were no adverse effects on the F1 offspring viability, clinical signs, physical or sexual development. No test item related macroscopic finding were was recorded for F1 pups at necropsy.
No endocrine disruptor effect of test item was observed in the study.
In conclusion, under the conditions of this study, the no observed adverse effect level (NOAEL) for the test substance is considered to be 1000 mg/kg bw/day for the female and male parental/adult generation, and also for the F1/pups generation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Mode of Action Analysis / Human Relevance Framework
No test item related toxicity was detected in a 28day rat study.
Additional information
Justification for classification or non-classification
Bases on the available data, the substance is not classified according to Regulation (EC) No 1272/2008.
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