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EC number: 953-917-1 | CAS number: -
- 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
From the findings of an OECD 422 study conducted on the source substance, the parental NOAEL
for the test animals was considered to be 100 mg/kg/day; however, findings at 500 and 1000 mg/kg/day
were confined to salivation, and kidney findings which may be reversible and not relevant in man. The neonatal NOEL
was considered to be 500 mg/kg/day. As the parental findings in this study are thought not to be relevant in man,
the parental NOAEL for man could be considered to be 1000 mg/kg/day.
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
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 500 and 1000 mg/kg/day, there was a dose related increase in number of animals with salivation (12/20 animals at 500 mg/kg/day and 21/30 animals at 1000 mg/kg/day). Salivation was generally evident immediately after dosing and up to ca 2 hrs post dose. There were a total of 2 premature decedent females on the study: Animal 64 (500 mg/kg/day) and Animal 71 (1000 mg/kg/day). These deaths were considered incidental for Animal 64 and not positively attributed to treatment for Animal 71.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 500 and 1000 mg/kg/day, there was a dose related increase in number of animals with salivation (12/20 animals at 500 mg/kg/day and 21/30 animals at 1000 mg/kg/day). Salivation was generally evident immediately after dosing and up to ca 2 hrs post dose. There were a total of 2 premature decedent females on the study: Animal 64 (500 mg/kg/day) and Animal 71 (1000 mg/kg/day). These deaths were considered incidental for Animal 64 and not positively attributed to treatment for Animal 71.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- At 500 and 1000 mg/kg/day, occasional salivation noted in some males and females.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Kidney weights statistically higher than Controls in main study males receiving 500 or 1000 mg/kg/day when adjusted for body wt.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- At 500 and 1000 mg/kg/day, microscopic findings were noted in the kidneys (basophilic tubules and hyaline droplets) of the main study males, considered to be treatment related.
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
- Conclusions:
- At 1000 mg/kg/day, there was an increase in the number of animals giving birth to dead pups and also in the number losing more than 3 pups over Days 0-4 of lactation, compared with Controls. Therefore, for the neonatal toxicity, the Lowest Observed Adverse Effect Level (LOAEL) was 1000 mg/kg/day and the No Observed Effect Level (NOEL) was considered to be 500 mg/kg/day.
From the findings on this study, the parental NOAEL was considered to be 100 mg/kg/day, however, findings at 500 and 1000 mg/kg/day were confined to salivation, and kidney findings which may be reversible and not relevant in man. The neonatal NOEL was considered to be 500 mg/kg/day.
As findings in this study were considered not to be relevant in man, the parental NOAEL for man could be 1000 mg/kg/day. - Executive summary:
The objective of this study was to assess the toxicity of the source substance in the rat after oral administration. The study was designed to assess possible effects on reproduction and/or development. The males were treated for 2 weeks prior to mating, through to necropsy (ca 4 weeks of treatment). Females were treated for 2 weeks prior to mating, then through mating, gestation and until at least Day 4 of lactation (ca 6 weeks of treatment). Recovery males and females had a 14 day recovery period prior to termination. The recovery animals were necropsied and the organ weight and histopathology data were compared to those of the main study animals.
The animals were monitored daily for any signs of ill health or reaction to treatment. Detailed functional observations were performed weekly, with additional functional observations performed on 5 males and 5 females per group on one occasion; week 4 for males and during early lactation for females.
Blood samples were also taken from 5 males and 5 females per group for laboratory investigations. Males were sampled during week 4 and females were sampled during lactation. In addition, histopathology was conducted on tissues from 5 males and 5 females
from Control and High dose groups.
Treatment with HF-1000 was associated with salivation in animals treated at 500 and 1000 mg/kg/day. The salivation was generally evident immediately after dosing and was evident up to ca 2 hours post dose and may have been due to an unpleasant taste associated with the test item.
The type and distribution of neurotoxicity observations, the haematology parameters and the coagulation and clinical chemistry parameters did not indicate any association with treatment.
At 500 and 1000 mg/kg/day, there was a statistically significant increase in the kidney weights of the main study males, however the kidney weights of the recovery males (1000 mg/kg/day) were similar to those of Controls.
Histopathology findings in the male kidneys (basophilic tubules and hyaline droplets) were noted in main study males treated at 500 and 1000 mg/kg/day. There were associations between increased hyaline droplets in the proximal renal tubules, increased basophilic tubules and the increased kidney weights at these levels. The findings in recovery males were confined to 2/10 with basophilic tubules compared to 1 in Controls.
The hyaline droplets that form in the male rat renal tubules following the administration of materials such as HF-1000 (volatile hydrocarbon) contain alpha-2microglobulin, and are unlikely to occur with hydrocarbon administration in man, as little or none of this protein is present in man, Greaves (2007).
Mating performance and pregnancy performance were similar across the groups.
At 1000 mg/kg/day, there was an increase in the number of animals giving birth to dead pups and also in the number losing more than 3 pups over Days 0-4 of lactation, compared with Controls. Therefore, for the neonatal toxicity, the Lowest Observed Adverse Effect Level (LOAEL) was 1000 mg/kg/day and the No Observed Effect Level (NOEL) was considered to be 500 mg/kg/day.
From the findings on this study, the parental NOAEL was considered to be 100 mg/kg/day, however, findings at 500 and 1000 mg/kg/day were confined to salivation, and kidney findings which may be reversible and not relevant in man. The neonatal NOEL was considered to be 500 mg/kg/day.
As the parental findings in this study are thought not to be relevant in man, the parental NOAEL for man could be considered to be1000 mg/kg/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of repeated dose toxicity via oral route
- systemic effects endpoint:
Well-conducted study according to established protocol
Justification for classification or non-classification
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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