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Diss Factsheets
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EC number: 615-497-5 | CAS number: 71809-65-9
- 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
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been conducted in compliance with GLP and according to the OECD guideline 423.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 32085-79-3
- EC Number:
- 608-700-3
- Cas Number:
- 32085-79-3
- IUPAC Name:
- 32085-79-3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD / Crl:CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males approx. 6 weeks, females approx. 7 weeks
- Weight at study initiation: males 210-242 g, females 200-203 g
- Housing: 3 animals/cage
- Diet: Feeding was discontinued approx. 16 hours before administration
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropylmethylcellulose
- Details on oral exposure:
- The test substance was suspended in 0.8% aqueous hydroxypropylmethylcellulose gel to obtain a concentration of 200 mg Gly-Dane salt (W)/mL.
The administration volume was 10 mL/kg b.w. in order to obtain a dose of 2000 mg Gly-Dane salt (W)/kg b.w. - Doses:
- 2000 mg Gly-Dane salt (W)/kg b.w.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Observations were performed before and immediately, at 5, 15, 30 and 60 min, as weil as at 3, 6 and 24 hours after administration. All surviving
animals were observed for a period of 14 days.
During the follow-up period (2 weeks), changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and
central nervous system, somatomotor activity as weil as behaviour pattern were observed at least once a day until all symptoms subsided,
thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily to minimize loss of animals during the study. The time of death was recorded as precisely aspossible. Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the
study, and at death. Changes in weight were calculated and recorded.
At the end of the experiments, all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were
recorded. No histopathology was carried out as no macroscopical findings were noted at autopsy. Autopsy and macroscopic inspection of animals which died prematurely were carried out as soon as possible after exitus.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- Under the present test conditions, a single oral administration of 2000 mg Gly-Dane salt (W)/kg b.w. did not reveal any clinical signs of toxicity.
- Body weight:
- The animals gained the expected weight throughout the whole study period.
- Gross pathology:
- No pathological findings
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of this study indicate that the LD50 of the test item is >2000 mg/kg bw.
- Executive summary:
The results of this study indicate that the LD50 of the test item is >2000 mg/kg bw.
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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