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Diss Factsheets
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EC number: 931-384-6 | 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:
- 21 March 1990 - 20 April 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study protocol was not in accordance with modern guidelines, which for example would have required fewer animals, but the scientific basis of the method followed is nevertheless robust
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (animals were not observed 30 minutes after dosing)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report):
- Substance type: Complex reaction product
- Physical state: Liquid
- Analytical purity: Assumed to be 100% pure for the purposes of dosing
- Impurities (identity and concentrations): NA
- Composition of test material, percentage of components: The study report does not contain information on test material characterisation or analysis; it confirms this information is held by the study sponsor Paramins Technology (now Infineum)
- Isomers composition: NA
- Purity test date: NDA.
- Lot/batch No.: I.
- Expiration date of the lot/batch: NDA.
- Stability under test conditions: NDA.
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CDBr (Sprague-Dawley)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston Facility, Stone Ridge, New York.
- Age at study initiation: Males, approximately 8 weeks old; females, approximately 11 weeks old.
- Weight at study initiation: Males 230–243 g; females 203–211 g.
- Fasting period before study: Food witheld overnight prior to dosing.
- Housing: Individual, except during the first week of acclimation. Suspended stainless steel cages.
- Diet (e.g. ad libitum): Ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-76 ºF (20-24.4ºC).
- Humidity (%): 30-70%.
- Air changes (per hr): Not stated.
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.
IN-LIFE DATES: From: 22 March 1990 To: 05 April 1990.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.96 mL/kg.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations : Animals were observed for viability and signs of toxicity at 1, 2, 4 and 6 hours after dosing and at least daily thereafter.
- Frequency of weighing: Individual bodyweights were recorded prior to dosing, at initiation of dosing (Day 0), and at Day 7 and Day 14 (or at death for animals dying during the study).
- Necropsy of survivors performed: Yes. - Statistics:
- The mean and standard deviations of the body weights and body weight changes were calculated.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- 2 000 mg/kg bw
- Remarks on result:
- other: Estimated LD50
- Mortality:
- Five (2 male and 3 female) animals died on the day of dosing (Day 0). The remaining five animals survived to termination.
- Clinical signs:
- other: In-life signs of toxicity most frequently observed included: tremors; oral, nasal and ocular discharge; staining of the anogenital and abdominal areas. Other signs included hypoactivity, hypothermia, abnormal stool production, hyperactivity, convulsions a
- Gross pathology:
- Gross pathology of animals that died during the study included abnormalities of the gastrointestinal tract, liver and lungs. Single incidences of undescended testes and an abnormal white mass within the urinary bladder were also noted. No gross pathology was found in surviving animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Five of the ten animals died on the day of dosing. Necropsy of these animals revealed abnormalities of the gastrointestinal tract, liver and lungs. Single incidences of undescended testes and an abnormal white mass within the urinary bladder were also noted. The five remaining animals survived until study termination and displayed no gross pathology at necropsy. Based on the five deaths, an approximate LD50 of 2,000 mg/kg may be estimated.
- Executive summary:
The test material was assessed for acute oral toxicity potential in a GLP study (limit test) in Sprague-Dawley rats. Five males and five females were administered the neat test material by gavage at a dose of 2,000 mg/kg bodyweight and observed for 14 days. Body weights were measured prior to dosing, one week after dosing, and prior to termination. Two males and three females died on the day of dosing. Gross necropsy of these animals revealed abnormalities of the gastrointestinal tract, liver and lungs. Single incidences of undescended testes and an abnormal white mass within the urinary bladder were also noted. The five remaining animals survived until study termination and displayed no gross pathology at necropsy. Based on the five deaths, an approximate LD50 of 2,000 mg/kg may be estimated.
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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