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Diss Factsheets
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EC number: 244-311-1 | CAS number: 21282-97-3
- 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:
- December 1984 - January 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with international guidelines.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Test material form:
- other: yellowish-white liquid
- Details on test material:
- Label: P5306
Storage: In a cool place at less than 30°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Ten male and 10 female Wistar-derived rats of the Cr1:(WI)BR strain obtained from Charles River (UK) Ltd., Margate, were used for the study.
On the day before treatment the weight of the males was between 210 and 224 g, those of the females between 195 and 206 g. The animals were
acclimatised to the laboratory environment for at least 3 days. Before starting the study all animals were examined for signs of ill health or injury.
All animals appeared healthy and no animals were discarded. The animals were housed in a single air conditioned room maintained at a temperature
and relative humidity of 19 to 25°C and 40 to 70% respectively. Fluorescent lighting was automatically controlled to give a cycle of 12 hours light
and 12 hours darkness. Environmental conditions were recorded twice daily on week-days and once daily at week-ends.
Animals were housed in groups of 5 by sex in grid floor stainless steel cages. Water bottles were cleaned at intervals during the study.
With the exception of an overnight fast prior to dosing the animals were allowed free access to food (SQC Rat and Mouse Maintenance Diet No.1,
Expanded; Special Diets Services Ltd., Witham). Mains water was provided at all times and dispensed from glass water bottles. The diet and drinking
water were considered not to contain any contaminant at a level that might have affected the objectives or integrity of the study.
The food was re-introduced immediately after treatment.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- Screening study:
---------------
50, 250, 1000, 2000 and 5000 mg/kg
Single dose level study:
---------------------
5000 mg/kg - No. of animals per sex per dose:
- Screening study:
---------------
50, 250, 1000, 2000 and 5000 mg/kg (five groups), each of 2 rats (1 male, 1 female)
Single dose level study:
---------------------
One group of 10 rats (5 males, 5 females) - Control animals:
- no
- Details on study design:
- The test article preparations were administered once only by oral gavage using a metal stomach tube (14 gauge x 8 cm long,
Stand Medicals Ltd., Manchester) attached to a disposable plastic syringe. Fresh formulations of the test article were made for each
study.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred in the screening study. In the single dose level Study all animals survived the study period.
- Clinical signs:
- other: All animals appeared normal throughout the study period.
- Gross pathology:
- All animals were subjected to necropsy. No abnormalities were noted.
- Other findings:
- No other findings were observed.
Any other information on results incl. tables
Single dose level study:
Appearance, behaviour and general observations:
All animals were observed for overt signs of toxicity or behavioural changes at 1/4, 1, 2 and 4 hours after treatment and subsequently once daily for 14 days. All observations were recorded.
Body weight:
Individual body weights were recorded on the day before treatment (day-1), on the day of treatment, and on days 7 and 14. Necropsy:
All animals were subjected to a gross necropsy examination. No tissues were retained. The animals were killed by exposure to high levels of carbon dioxide.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of P5306 in the Wistar-derived rat was estimated to be greater than 5000 mg/kg bodyweight.
- Executive summary:
The acute oral toxicity study was performed from Dezember 1984 - January 1985 according to OECD Guideline 401 and GLP.
No mortalities occurred throughout the study period. No clinical signs were observed. All animals were subjected to necropsy. No abnormalities were noted. The acute oral median lethal dose (LD50) of P5306 in the Wistar-derived rat was estimated to be greater than 5000 mg/kg bodyweight.
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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