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Diss Factsheets
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EC number: 944-251-2 | 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 Key study : Test for oral toxicity in rats is a key study from O.M. MB Research Laboratories dated on 1980. This acute oral toxicity with male Wistar rats was performed according to an equivalent to OECD 401 guideline.
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:
- weight of evidence
- Study period:
- 16 June - 30 June, 1980
- Reliability:
- 4 (not assignable)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Remarks:
- This study was conducted in compliance with the FDA's Good Laboratory Practices effective 6/20/79.
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Material Identification (as stated in the report) : Gyrane #80-38
Appearance: Clear liquid
Sample received on 06/02/80 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: 202 - 268 g
- Fasting period before study: 16-20 hours
- Housing: Five animals per cage were housed in suspended wire mesh cages.
- Diet: Fresh Purina rat chow was freely available
- Water: Water was freely available - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test arzicle was given by orally by syringue and a dosing needle.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed 3-4 hours after dosing and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and clinical signs, gross pathology. - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- One instance of chromodacryorrhea was noted 3-4 hours post dose.
Isolated instances of hyperactivity, prostration, piloerection, ptosis, tachypnea and chromodacryorrhea were noted during the study. Nine animals were normal on day 14. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity with male Wistar rats performed equivalent to OECD 401 guideline, a LD50 >5000 mg/kg bw was determined.
- Executive summary:
Gyrane was tested in an acute oral toxicity study with male Wistar rats at 5000 mg/kg body weight. The study was performed equivalent to OECD 401 guideline and according to GLP principles.
No mortality occurred in 10 male rats from an oral dose of Gyrane, at 5.0 g/Kg. Minimal toxic signs were present and the necropsy findings were normal.
Thus, the LD50 of Gyrane was determined to be : LD50>5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The quality of the key study with a Klimisch score of 4 but with no deaths observed at 5000 mg/kg out of 10 animals, is sufficient for classification determination.
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 Inhalation Toxicity
In line with Column 2, point 8.5.2, Annex VIII of Regulation 1907/2006, an acute inhalation study does not need to be performed as the substance has a low vapour pressure and the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The acute toxicity endpoint has been addressed by assessing the toxicity via the oral , which is more appropriate when considering the properties of this substance.
Acute Dermal Toxicity
An acute dermal toxicity study does not need to be performed as the substance doe snot meet the criteria for classification as acute toxicity or STOT SE by the oral route (LD50 oral > 5000 mg/kg bw) and no systemic effects have been observed in the in vivo studies with Dermal exposure ( skin irritation and sensitization studies).
Justification for classification or non-classification
In the key study, no mortality occurred in 10 male rats from an oral dose of Gyrane, at 5.0 g/Kg. Minimal toxic signs were present and the necropsy findings were normal. Thus, the LD50 of Gyrane was determined to be : LD50>5000 mg/kg bw. Therefore, in accordance with Regulation (EC) No. 1272/2008, the substance does not meet the GHS criteria for classification for acute oral toxicity.
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.
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