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EC number: 275-174-6 | CAS number: 71077-31-1
- 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 (OECD TG 401): >5000 mg/kg bw.
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:
- 09 October 1986 - 23 October 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliability 1 is assigned because the study is conducted according to OECD TG 401 (but there is no data on compliance with GLP), without deviations that influence the quality of the results.
- 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:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 110 - 147 g
- Fasting period before study: overnight
- Housing: groups by sex in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Labsure LAD 1)
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed soon after dosing, then at frequent intervals for the remainder of Day 1. On subsequent days animals were observed at least once in the morning and at the end of the experimental day. Individual body weights were recorded on day 1, 8 and 15.
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight, macroscopic post mortem examination (abdominal and thoracic cavities) - Statistics:
- Not relevant
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, pallor of the extremities and diarrhoea were observed in all rats on the day of dosing. On day 2 pilo-erection persisted in all rats. There were no other clinical
- Gross pathology:
- Terminal autopsy findings were normal.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity test showed an LD50 of >5000 mg/kg bw. Based on these results, the substance does not need to be classified for acute oral toxicity according to EU classification criteria.
- Executive summary:
In this study, 10 rats (5 males and 5 females) were administered the substance at a single dose level of 5000 mg/kg bw. The rats showed no mortality, but some clinical signs were noted on the first 2 days after dosing. A body weight increase was noted in all rats during the observation period (14 days). Necropsy was performed by opening the abdominal and thoracic cavities and checking the macroscopic appearance of the organs, but no abnormalities were found. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.
Reference
Results of the preliminary study indicated that the acute median lethal oral dose of Floral Super was >5000 mg/kg bw, as no mortality was observed in the treated animals (2 males, 2 females).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
Additional information
In this study, 10 rats (5 males and 5 females) were administered the substance at a single dose level of 5000 mg/kg bw. The rats showed no mortality, but some clinical signs were noted on the first 2 days after dosing. A body weight increase was noted in all rats during the observation period (14 days). Necropsy was performed by opening the abdominal and thoracic cavities and checking the macroscopic appearance of the organs, but no abnormalities were found. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
The result of this study is reliable and adequate for covering this endpoint.
Justification for classification or non-classification
According to the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP), the substance does not have to be classified as acute toxic by the oral route.
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