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EC number: 268-640-5 | CAS number: 68132-47-8
- 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
Description of key information
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be > 2000 mg/kg bw (OECD 420 and EU Method B.1 bis)..
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 August 2016 to 10 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- delay in 30-minute post dose observation for animal number 2-0 with no impact on integrity or validity of the study (see below)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- yes
- Remarks:
- delay in 30-minute post dose observation for animal number 2-0 with no impact on integrity or validity of the study (see below)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- ANIMAL INFORMATION
- Female Wistar (RccHan:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK.
- On receipt the animals were randomly allocated to cages.
- The female animals were nulliparous and non-pregnant.
- After an acclimatisation period of at least five days, animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on the cage card.
- At the start of the study the animals were 8 to 12 weeks of age.
- Body weight variation did not exceed ± 20 % of the mean body weight at the start of treatment.
ANIMAL CARE AND HUSBANDRY
- Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- With the exception of an overnight fast immediately before dosing, and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study.
- Diet and drinking water were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
- Temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70 % respectively.
- Rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
- Animals were provided with environmental enrichment items that were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- EXPOSURE TO TEST ITEM
- All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe.
- The volume administered to each animal was calculated according to the fasted body weight at the time of dosing.
- Treatment of animals was sequential.
- Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.
- Clinical observations were made 0.5, 1, 2 and 4 hours after dosing and then daily for 14 days.
- Morbidity and mortality checks were made twice daily (early and late during normal working days and once daily at weekends and public holidays).
- Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- At the end of the observation period animals were killed by cervical dislocation.
- All animals were subjected to gross necropsy consisting of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Doses:
- - Sighting test: 300 mg/kg bw and 2000 mg/kg bw
- Main investigation: 2000 mg/kg bw - No. of animals per sex per dose:
- - One animal at 300 mg/kg bw
- Five animals at 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- TEST ITEM PREPARATION AND ANALYSIS
- The test item was freshly prepared, as required, as a solution in dimethyl sulphoxide. This vehicle was chosen because the test item did not dissolve/suspend in distilled water or arachis oil BP.
- The test item was formulated within 2 hours of being applied to the test system and was assumed to be stable for that duration.
- No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This was an exception with regard to GLP and was reflected in the GLP compliance statement.
STUDY DESIGN
- In the absence of data regarding the toxicity of the test item, the starting dose was chosen as 300 mg/kg (see Annex 2 and Annex 3, attached).
- A single female animal was treated at a dose level of 300 mg/kg (concentration 30 mg/mL; dose volume 10 mL/kg).
- In the absence of toxicity at a dose level of 300 mg/kg, an additional female animal was treated at a dose level of 2000 mg/kg (concentration 200 mg/mL; dose volume 10 mL/kg).
- In the absence of toxicity at a dose level of 2000 mg/kg, an additional four female animals were treated at a dose level of 2000 mg/kg (concentration 200 mg/mL; dose volume 10 mL/kg). - Statistics:
- DATA EVALUATION
- The test item was evaluated according to Annex 3 of the OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity – Fixed Dose Method” (adopted 17 December 2001) as shown in the flow chart in Annex 2 (attached).
- Evaluation of data included identification of the number of animals that died during the study (or that were killed for humane reasons) plus determination of the nature, severity, onset and duration of toxic effects. If possible, the signs of evident toxicity were described. Evident toxicity refers to the toxic effects of sufficient severity that administration of the next higher dose level could result in development of severe signs of toxicity and probable mortality. Effects on body weights and abnormalities noted at necropsy were also identified.
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made. - Preliminary study:
- - Individual clinical observations and mortality data for the 300 mg/kg dose level are given in Appendix 1 (attached).
- No mortality was observed.
- No signs of systemic toxicity were noted during the observation period.
- Individual body weight and body weight changes are given in Appendix 2 (attached).
- The animal showed expected gains in body weight over the observation period.
- Individual necropsy findings are given in Appendix 3 (attached).
- No abnormalities were noted at necropsy. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - Individual mortality data for the 2000 mg/kg dose level are given in Appendix 4 (attached).
- No unscheduled animal deaths took place. - Clinical signs:
- other: - Individual clinical observations for the 2000 mg/kg dose level are given in Appendix 4 (attached). - No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- - Individual necropsy findings for the 2000 mg/kg dose level are given in Appendix 6 (attached).
- No abnormalities were noted at necropsy. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be > 2000 mg/kg bw.
- Executive summary:
GUIDELINE
The study was performed to assess acute oral toxicity of the test item in the Wistar strain rat in compliance with the OECD Guideline for Testing of Chemicals No 420 “Acute Oral Toxicity – Fixed Dose Method” (2001) and Method B.1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No 440/2008.
METHODS
Following a sighting test at dose level of 200 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a solution in dimethyl sulphoxide, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
RESULTS
No animal deaths took place during the study and clinical observations resulted in no reports of systemic toxicity. All animals showed expected gains in body weight and no abnormalities were noted at necropsy.
CONCLUSION
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral route
The study was performed to assess acute oral toxicity of the test item in the Wistar strain rat in compliance with the OECD Guideline for Testing of Chemicals No 420 “Acute Oral Toxicity – Fixed Dose Method” (2001) and Method B.1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No 440/2008.
Following a sighting test at dose level of 200 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a solution in dimethyl sulphoxide, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
No animal deaths took place during the study and clinical observations resulted in no reports of systemic toxicity. All animals showed expected gains in body weight and no abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be > 2000 mg/kg bw.
Dermal route
Experimental data shows that the substance is a paste with low oral toxicty under acute conditions (LD50 > 2000 mg/kg) and repeated exposure of the skin is not expected under normal condition of use. In addition, the test material has been determined to have a low vapour pressure (0.475 Pa at 25 °C) and high onset boiling point range (partial boiling over the range 150 to 273 °C (423 to 546 K) with further boiling from approximately 317 °C (590 K) at 101 to 102 KPa). These data indicate that the potential for dermal absorption after exposure to vapour is low. Furthermore, the substance is a UVCB with a relatively high molecular weight, is poorly soluble (< 5.16 x 10E-02 g/L at 20.0 ± 0.5 °C based on a nominal loading rate of 0.1 g/L. at 20 °C) and has a Log10 Kow value range of 5.93 to 7.41. Consequently, and in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance (Version 2.0; November 2014), the substance is considered insufficiently soluble to partition from the stratum corneum into the epidermis and the majority of UVCB constituents are likely to be too large to favour dermal absorption (molecular weight > 100 g/moL and log10 Pow > 4). Investigation of acute toxicity via the dermal route is therefore contraindicated.
Inhalation route
The substance is a paste that partially boils over the range 150 to 273°C (423 to 546 K) with further boiling from approximately 317 °C (590 K) at 101 to 102 KPa and the vapour pressure has been determined to be 0.475 Pa at 25 °C. It is therefore expected that inhalation exposure from identified uses will be low. In addition, the most likely route of exposure for workers and consumers is the dermal route.
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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