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Diss Factsheets
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EC number: 233-117-2 | CAS number: 10039-33-5
- 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
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Endpoint summary
Administrative data
Description of key information
NOAEL (oral)= 5 mg/kg diet (based on the effects noted in the thymus) in the rat, equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 0.525 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- System:
- endocrine system
- Organ:
- thymus
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
For the evaluation of the toxicity of the substance after repeated dose, data on Similar Substance 01 is used. Justification for Read Across is given in Section 13 of IUCLID.
The repeated dose toxicity of the analogue substance was assessed in a repeated dose toxicity and reproductive and developmental screening study in rats. The study was performed in accordance with GLP and to the standardised guideline OECD 422. Four groups of 12 male and 12 female rats were exposed to 0 (control), 5, 25 and 250 mg/kg diet daily for 28 days. All animals were observed for mortality, clinical signs, body weight and were subjected to clinical chemistry haematology analysis and neurobehavioural examination. Microscopic examination was performed on the collected organs of all rats in the control and high-dose group. The reproductive organs of males that failed to sire (mated female which was not pregnant) and females that were non-mated or non-pregnant of the mid and low dose groups were microscopically examined. The liver and ovaries of females and the thymus of the male and female rats in the low and mid-dose groups were also evaluated.
Only one death was noted during the study, and this was not attributed to toxicity of the test material. The absolute thymus weight in the males of the 250 and 25 mg/kg groups and the relative thymus weight in the high dose male rats were found to be significantly decreased. In the mid-dose group the relative thymus weight was also statistically significantly decreased. Microscopic evaluation of the thymus revealed moderate to very severe lymphoid depletion in all animals (both sexes) of the 250 mg/kg group and in all females of the 25 mg/kg group. The macroscopically observed thymi in 5 control and 7 low dose females exhibited no microscopic abnormalities.
Based on the effects noted in the thymus in both male and female rats in the 25 mg/kg diet groups, the NOAEL (oral) was concluded to be the lowest group tested, 5 mg/kg diet which was equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals.
For the chemical safety assessement, the NOAEL of 0.3 mg/kg bw/day is used which corresponds to Similar Substance 01 doses. Readjusting to Target substance doses, considering the molecular weights of both substances, a 0.525 mg/kg bw/day is calculated.
Justification for classification or non-classification
The classification or non-classification of the substance as specific target organ toxicant following repeated exposure was assessed by taking into consideration the results of the Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test. During the short-term oral repeated toxicity study, decreased thymus weight and microscopic and macroscopic changes in the thymus were observed at the 25/mg kg/diet group. Based on these effects a NOAEL (oral) equal to 5 mg/kg diet equivalent to 0.3-0.4 mg/kg bw/day for male rats and 0.3-0.5 mg/kg bw/day for female rats was determined.
Significant toxic effects observed in the 28-day repeated-dose study conducted in rats are seen to occur below the guidance values (C) proposed in the CLP Regulation. In accordance with the CLP Regulation (EC) No. 1272/2008, the substance is classified as STOT Rep. Exp. 1: H372: Causes damage to organs (thymus) through prolonged or repeated exposure.
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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