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Diss Factsheets
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EC number: 435-780-5 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 April to 27 May 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- - Appearance: amber-coloured, slightly viscous liquid
- Storage conditions: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna (U.K.) Limited, Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: ca. 5 - 8 weeks
- Weight at study initiation: males: 211 - 234 g; females: 161 - 181 g
- Fasting period before study: yes (overnight before dosing and ca. 2 hours after dosing)
- Housing: animals were housed in groups of up to 5 by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum (Rat and Mouse Expanded Diet No. 1, Special Diet Services Ltd)
- Water: ad libitum
- Acclimation period: 5 days (minimum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Humidity (%): 55 - 68 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5.77 mg/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and overt signs of toxicity 1 and 4 hours after dosing and subsequently once daily for 14 days. Bodyweights were recorded on the day of dosing (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- None of the animals died during the preliminary study and subsequently, the top dose of 5000 mg/kg bw was selected for the main study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study period.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study period. All animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the acute oral LD50 of the test material was determined to be in excess of 5000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test material was evaluated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines EU Method B.1 and OECD 401.
During the study, the test material was administered by oral gavage to one group of five male and five female Sprague-Dawley rats at 5000 mg/kg bw. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. All animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on day 15.
None of the animals died during the study and no clinical signs were noted. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Furthermore, no abnormalities were found at macroscopic post mortem
examination of the animals.
Therefore, under the conditions of the study, the oral LD50 value of the test material in male and female Sprague-Dawley rats was in excess of 5000 mg/kg bw, the highest permissible dose level tested.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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