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EC number: 429-460-4 | CAS number: 7078-98-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Substituted Quinone Methide
- IUPAC Name:
- Substituted Quinone Methide
- Details on test material:
- Storage: The test article was stored at room temperature and humidity.
Description: Yellow crystalline solid.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals were received from Ace Animals, Boyertown, PA.
- Age at study initiation: Approximately four to twelve weeks.
- Weight at study initiation: 220 - 299 grams for male and 224 - 268 grams for females.
- Fasting period before study: 16-20 hours prior to dosing.
- Housing: The animals were housed 5/sex/cage in suspended wire cages.
- Diet (e.g. ad libitum): Fresh Purina Rat Chow was freely avaiable (except during fasting period).
- Water (e.g. ad libitum): Water was freely available at all times.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The animal room was temperatue controlled.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE:
Corn oil
DOSAGE PREPARATION:
The test article was ground with a mortar and pestle. 15 g was mixed with corn oil to a total volume of 30 ml and dosed from a stir plate. The dose was based on the dry weight of the test article. A single dose was administered orally by syringe and dosing needle. - Doses:
- 5000 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per dose.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects.
The animals were observed twice daily for mortality. Body weights were recorded immediately pretest, on days 3 and 7, at death or at termination in the survivors.
- Necropsy of survivors performed: yes, all animals were examined for gross pathology. - Statistics:
- An estimate of the LD50 was made based on the results.
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:
- One male rat from the high dose group (5000 mg/kg) died on day 3 and one from the 2000 mg/kg dose group died on day 2.
- Clinical signs:
- other: 5000 mg/kg: One male died on day 3 with predeath physical signs of diarrhea, chromodacryorrhea, soiling of the anogenital area, piloerection, lethargy, flaccid muscle tone, brown staining of the nose/mouth area and wetness of the anogenital area. Physica
- Gross pathology:
- Necropsy of the animal that died at the 5000 mg/kg level revealed abnormalities of the thymus, lungs, liver, kidneys, spleen and gastrointestinal tract, as well as soiling and wetness of the anogenital area. Necropsy results of survivors were normal in 2/9 animals dosed at 5000 mg/kg.
Localized alopecia was noted in the remaining seven animals.
All animals dosed at 2000 mg/kg appeared normal at necropsy.
No necropsy was performed on the animal that died at the 2000 mg/kg level since it was cannibalized.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 is greater than 5000 mg/kg.
- Executive summary:
Objective:
To determine the potential for toxicity of the test article when administered orally to rats. This study was designed to comply with the standards set forth by:
EC Official Joumal of the European Communities. L 383 A Part B, Method B.l. Acute Oral Toxicity 12/29/92.
OECD Guidelines for Testing of Chemicals, No. 401, Acute Oral Toxicity, adopted 2/24/87.
Method:
Five healthy male and five healthy female Wistar albino rats were dosed orally with the test substance at 5000 mg/kg of body weight. Since test article related mortality occurred at this level, an additional group of five male and five females were dosed at 2000 mg/kg of body weight. The rats were observed 1,2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for mortality. Body weights were recorded immediately pretest, on days 3 and 7, at death or at tennination in the survivors. All animals were examined for gross pathology.
Results:
5000 mg/kg: Nine of ten animals survived the 5000 mg/kg oral dose. One male died on day 3 with predeath physical signs of diarrhea, chromodacryonliea, soiling of the anogenital area, piloerection, lethargy, flaccid muscle tone, brown staining of the nose/mouth area and wetness of the anogenital area. Necropsy revealed abnonnalities of the thymus, lungs, liver, kidneys, spleen and gastrointestinal tract, as well as soiling and wetness of the anogenital area. Physical signs noted in survivors included diarrhea, soiling of the anogenital area, lethargy, bloated abdomen, piloerection, wetness of body areas, brown staining of the nose/mouth area and localized alopecia. Body weight changes were nonnal in 7/9 survivors. Two males lost weight by day 3 but gained normally by day 7. Necropsy results of survivors were normal in 2/9 animals. Localized alopecia was noted in 7/9 animals.
2000 mg/kg: Nine of ten animals survived the 2000 mg/kg oral dose. One male died on day 2 with predeath physical signs of lethargy, dyspnea and soiling of the anogenital area. A necropsy was not performed since the animal was cannibalized. Physical signs of diarrhea, soiling of the anogenital area, lethargy, brown staining of the nose/mouth area and wetness of the anogenital area were noted in survivors. Body weight changes were normal in 8/9 survivors. One female lost weight during the second week of the observation period. Necropsy results of survivors were normal.
Conclusion:
The LD50 is greater than 5000 mg/kg.
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