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Diss Factsheets
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EC number: 915-586-1 | 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity study in the rat
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:
- 5-11-1993 to 5-24-1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: EPA/OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- other: All animals dosed with a single dose of 5g/kg body weight
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult male and female albino rats weighing between 200 and 229 grams were used for this study. The rats were obtained from Harlan Sprague Dawley, Inc., Indianapolis, Indiana. The rats used for this study were identified by ear tags and were individually housed in stainless steel cages in a temperature, humidity, and light-controlled room (room 15B). The animals were maintained according to the recommendations contained in DHHS Publication No. 86-23 (NIH): Revised 1985, "Guide for the Care and Use of Laboratory Animals." They were conditioned for 5 days prior to initiation of the study. Except for described periods associated with dosing, Purina Rat Chow and water were available ad libitum. Animals were selected randomly from the acclimated colony and assigned to the test group.
Justification for Selection of Test System: The Sprague-Dawley rat has been used extensively as an animal model for oral toxicity testing. - Route of administration:
- oral: gavage
- Vehicle:
- other: mineral oil
- Details on oral exposure:
- The test material was administered by oral gavage to fasted (overnight) animals (five males and five females per dose group) according to individual body weights. A dose level of 5 g/kg body weight was administered via a metal dosing cannula.
- Doses:
- 5 g/kg body weight
- No. of animals per sex per dose:
- 5 males and 5 females per dose group.
- Control animals:
- no
- Details on study design:
- The rats were observed for any toxic or deleterious effects at 1, 2.5, and 4 hours after dosing and then twice daily for 14 days. Animal body weights were obtained at study initiation, and at 7 and 14 days post-administration. A gross necropsy examination was performed on all animals at the end of the 14-day observation period.
- Statistics:
- There was no mortality observed during the course of the study. It was not necessary to calculate the LD50 or 95% Confidence Limits.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality observed during the course of the study.
- Clinical signs:
- other: A summary of pharmacotoxic observations is available in Table 2. The primary pharmacotoxic observations were hunched posture and loose stool, and occurred on study day 1 and 2. All animals appeared normal from study day 3 to study termination.
- Gross pathology:
- Individual gross necropsy observations are presented in Table 3. There were no gross changes observed in any of the animals at terminal necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the results of this study, the acute oral LD50 of Automate Yellow 8 Petroleum is greater than 5 g/kg body weight.
- Executive summary:
Automate Yellow 8 Petroleum was administered by oral gavage to five male and five female rats at a dose level of 5 g/kg body weight. The animals were observed for pharmacotoxic signs and mortality during a 14 day observation period. A gross necropsy examination was performed on all animals at the end of the 14 day observation period.
All animals survived the study in apparent good health and exhibited normal weight gains during the study course. The primary pharmacotoxic observations were hunched posture and loose stool, and occurred during study day 1 and 2. All animals appeared normal from study day 3 until study termination. There were no gross changes observed in any of the animals at terminal necropsy.
Based upon the results of this study, the acute oral LD50 of Automate Yellow 8 Petroleum is greater than 5 g/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Good
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
Acute oral toxicity:
Automate Yellow 8 Petroleum was administered by oral gavage to five male and five female rats at a dose level of 5 g/kg body weight. The animals were observed for pharmacotoxic signs and mortality during a 14 day observation period. A gross necropsy examination was performed on all animals at the end of the 14 day observation period.
All animals survived the study in apparent good health and exhibited normal weight gains during the study course. The primary pharmacotoxic observations were hunched posture and loose stool, and occurred during study day 1 and 2. All animals appeared normal from study day 3 until study termination. There were no gross changes observed in any of the animals at terminal necropsy.
Based upon the results of this study, the acute oral LD50 of Automate Yellow 8 Petroleum is greater than 5 g/kg body weight.
Due to the very low order of acute oral toxicity, the low potential for dermal penetration (due to high log Kow - refer to phys chem section) and the low volatility (refer to phys chem section) it is considered that no further testing for acute toxicity is required.
Justification for selection of acute toxicity – oral endpoint
only availalbe, reliable acute oral toxicity study
Justification for classification or non-classification
No classified for acute toxicity according to CLP (or GHS)
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