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EC number: 293-316-5 | CAS number: 91053-50-8
- 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
Neurotoxicity
Administrative data
Description of key information
Key value for chemical safety assessment
Effect on neurotoxicity: via oral route
Link to relevant study records
- Endpoint:
- neurotoxicity: sub-chronic oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 422
- Deviations:
- yes
- Remarks:
- Study included FOB and motor activity endpoints
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.3650 (2000)
- Deviations:
- yes
- Remarks:
- Study included FOB and motor activity endpoints
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- All animals were dosed once daily by gavage for approximately 14 days prior to cohabitation and during the cohabitation period (up to 2 weeks). Male and female rats showing no evidence of copulation continued to be dosed after the end of the cohabitation period until sacrifice. Females showing evidence of copulation were dosed throughout gestation. Pregnant females in the process of delivery or showing signs of delivery were not dosed. Females were dosed after delivering litters, until day 3 postpartum. Females that did not deliver a litter continued to be dosed until the day before sacrifice.
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg
Basis:
actual ingested - No. of animals per sex per dose:
- 12 animals/sex/dose
- Control animals:
- yes, concurrent vehicle
- Neurobehavioural examinations performed and frequency:
- NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Pretest and near the end of the premating period
- Dose groups that were examined: All animals prior to dosing and at the end of the premating period
- Battery of functions tested: abbreviated functional observational battery (FOB) assessments and motor activity (MA). The FOB assessment included assessments of approach and touch, sharp auditory stimulus (e.g., clicker), tail pinch, forelimb grip strength, hindlimb grip strength, papillary constriction, polyuria, and diarrhoea. The motor activity monitors enabled the measurement of 2 dependent variables, duration or movement and number of movements. - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Remarks on result:
- other: no effects at highest dose tested
- Conclusions:
- NOAEL = 1000 mg/kg
- Executive summary:
The objective of this study was to evaluate the potential subchronic and reproductive/developmental toxicity of the test substance when administered by oral gavage to male and female rats during premating, cohabitation, gestation, until postnatal day (PND) 3. Four groups of parental (P0) male and female Crl:CD(SD) rats (12/sex/group) were administered formulations of the test substance via once daily oral gavage for 14 consecutive days prior to mating, throughout mating, and then continuing through one day prior to the day of euthanasia. The dose levels administered were 0, 100, 300, or 1000 mg/kg/day. Samples of the dose formulations were analyzed and confirmed that the formulations were at targeted concentrations, homogeneous, and stable under the conditions of use. During the in-life phase of the study, all animals were observed twice daily for appearance and behaviour. Clinical observations, body weights, and food consumption were recorded at appropriate intervals for P0 males throughout the study and for P0 females prior to mating and during gestation and lactation. Neurobehavioral examinations consisting of an abbreviated functional observational battery (FOB) and motor activity (MA) were performed for all P0 animals once prior to dosing to provide baseline data and once more near the end of the premating period. In addition, clinical pathology data consisting of haematology, coagulation, and clinical chemistry data were collected prior to the end of the premating period. All P0 females were allowed to deliver and rear their pups until weaning on PND 4. Each P0 parental animal received a complete detailed gross necropsy and selected organs were weighed and/or retained for histopathologic examination.
There was no evidence of test substance-related toxicity at any dose level tested. The in-life data, including body weight and food consumption parameters, clinical observations, neurobehavioural endpoints (FOB and MA), clinical pathology, as well as reproductive performance data including mating and fertility indices, gestation length, offspring viability, litter sizes, litter sex ratio, and pup weights, were comparable across all groups throughout the study. In addition, there were no test substance-related effects on either gross or microscopic histopathology or on organ weights.
Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for neurotoxicity was 1000 mg/kg/day. This conclusion is based on the lack of any evidence of any adverse and/or test substance-related effects at any dose level tested.
Reference
Refer to Section 7.5.1 Repeated dose toxicity: oral: DI.K1.28Day.Gav.Screen.RD/REPRO/DEV.R.D-18511-1422.KD for additional details of repeated dose systemic toxicity findings. Refer to Section 7.8.1 Toxicity to reproduction: DI.K1.DEV.Screen.RD/REPRO/DEV.R.D-18511-1422.KD for reproductive toxicity findings. Refer to Section 7.8.2 Developmental toxicity/teratogenicity: DI.K1.DEV.Screen.RD/REPRO/DEV.R.D-18511-1422.KD for developmental toxicity findings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
No effects on neurotoxicity (functional observational battery and motor activity) were observed in a repeated dose/one generation reproduction study (OECD 422), nor were any clinical signs suggestive of neurotoxicity observed in any other studies following acute exposure by oral, dermal, or inhalation routes of exposure.
Justification for classification or non-classification
Based on the lack of adverse effects on neurotoxicity at the highest dose tested (1000 mg/kg/day) in a repeated-dose toxicity study and the lack of evidence of neurotoxicity in acute toxicity studies, the test substance does not need to be classified for neurotoxicity or specific toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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