Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 223-211-1 | CAS number: 3770-97-6
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
RA to OECD 422: NOAEL for maternal systemic toxicity (42 d, oral, rat) = 200 mg/kg bw/d
RA to OECD 422: NOEL for reproductive performance (42 d, oral, rat) = 1000 mg/kg bw/d
RA to OECD 422: NOEL (systemic toxicity) for F1 -generation (42 d, oral, rat) = 1000 mg/kg bw/d
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- For this endpoint a read across was performed to a chemical similar compound that is also found after F6-Chloride degradation in aquous environment and under physiological conditions. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 422. A read across justification withb degradation pathway is provided in chapter 13 of this dossier.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- other: structural anlogue substance
- Sex:
- male/female
- Basis for effect level:
- food consumption and compound intake
- histopathology: non-neoplastic
- Remarks on result:
- other: pH adjsutment required
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- reproductive performance
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- other: structural analogue substance
- Sex:
- male/female
- Basis for effect level:
- other: no effects on reproductive performance were observed
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- stomach
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- other: strutural analogue substance
- Sex:
- male/female
- Basis for effect level:
- other: no effects were observed
- Remarks on result:
- other: pH must be adjusted
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Guideline and GLP conform study
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
For developmental toxicity no effects have been observed up to the highest dose of 1000 mg/kg bw/d.
RA to OECD 422: NOEL for maternal developmental toxicity (42 d, oral, rat) = 1000 mg/kg bw/d
RA to OECD 422: NOEL (developmental toxicity) for F1 -generation (42 d, oral, rat) = 1000 mg/kg bw/d
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- For this endpoint a read across was performed to a chemical similar compound that is also found after F6-Chloride degradation in aquous environment and under physiological conditions. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 422. A read across justification withb degradation pathway is provided in chapter 13 of this dossier.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- sytemic toxicity
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- other: structural analogue substance
- Basis for effect level:
- food consumption and compound intake
- histopathology: non-neoplastic
- Remarks on result:
- other: pH must be adjusted
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- maternal developmental toxicity
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- other: structural anlogue substance
- Basis for effect level:
- other: no effects were observed
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- developmental toxicity
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- other: structural analogue substance
- Sex:
- male/female
- Basis for effect level:
- other: no effects were observed
- Remarks on result:
- other: pH must be adjusted
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP and Guideline conform study
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data provided, the test item is not considered to be classified for reproductive toxicity after oral expsoure according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/776.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.