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EC number: 288-003-5 | CAS number: 85631-54-5
- 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
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- NOAEL is based on read across to the one generation reproductive toxicicity study with Fluoroalkylethanol mixture. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In order to evaluate the reproductive toxicity of the target substance and no study on reproductive toxicity is available with the target substance, read across to data from a 1 -generation reproductive toxicity with the source substance n:2 FTOH mixture was made.
Rats (20 per sex per group) were given dosages of 0, 25, 100, or 250 mg/kg/day for a period of 74 days prior to cohabitation, and during mating, gestation, and lacatation. The fluoroalkylethanol mixture (FTOH mixture) was administered daily by gavage to Sprague-Dawley rats as a suspension in 0.5% aqueous methylcellulose. All parameters for body weight gain, food consumption, reproductive performance, clinical signs, and developmental landmarks were evaluated as per OECD guidelines. The no observed adverse effect level (NOAEL) for general toxicity as well as reproductive and offspring effects is 25 mg/kg bw/day.
There were no test substance-related effects on estrous cycle parameters in the P1 generation.
There were no test substance-related effects on sperm morphology, motility, or epididymal sperm counts in the P1 generation.
Mating and fertility indices, mean gestation length, and number of implantation sites were comparable across groups.
Short description of key
information:
In order to evaluate the reproductive toxicity of the target
substance, and no study on reproductive toxicity is available with the
target substance, read across to data with the source substance n:2 FTOH
mixture was made. In accordance with Section 1, Subsection 1.5 of REACH
Annex XI, Grouping of substances and read-across approach, a
reproduction toxicity study information requirement 8.7.3 in Annex IX,
does not need to be conducted as the requirement is fulfilled by the one
generation reproductive toxicity study for the mixed Fluoroalkylethanol
(source substance). The underlying hypothesis for the read-across
provided within the IUCLID Assessment Reports section, supports the
read-across approach.
Effects on developmental toxicity
Description of key information
No developmental toxicity data are available for the registration substance. A prenatal developmental toxicity study in rats with n:2 FTOH mixed alcohol (source substance) was used as a read across to fulfill the data gap for the test substance.
In order to evaluate the pre-natal developmental toxicity of the mixed fluorotelomer alcohol, groups of time-mated Sprague-Dawley female rats were administered the test substance by oral gavage in 0.5% methylcellulose as vehicle at daily dosages of 0, 50, 200, or 500 mg/kg/d on gestation days 6-20. The no-observed-adverse effect level (NOAEL) for both the dam and the fetus was considered to be 200 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The reliability of the study is 2. The study is a scientific publication and well documented.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Groups of pregnant female Sprague-Dawley rats were administered the test substance (source substance) by oral gavage in 0.5% methylcellulose as vehicle at daily dosages of 0, 50, 200, or 500 mg/kg/d on gestation days 6-20 in a prenatal developmental toxicity study according to OECD 414. The no-observed-adverse effect level (NOAEL) for both the dam and the fetus was considered to be 200 mg/kg/day.
In
the developmental toxicity study, reduced maternal body weight
parameters, increased perianal fur staining and increased fetal skeletal
alterations (variations but no malformations) were observed at 500
mg/kg/d. There
was no evidence of either maternal or developmental toxicity at 50 or
200 mg/kg/d. Minimal fetal weight reduction in the 500 mg/kg/d group
were considered secondary to maternal toxicity.
Justification for selection of Effect on developmental toxicity: via
oral route:
The study is a scientific publication and well documented. The read
across hypothesis is based on the assumption that due to its
characteristic as ester, after ingestion in mammalians the ester bound
of the target chemical will be subject to metabolic cleavage into its
corresponding alcohols and the acrylic acid. Thus FTAC (target) and its
associated alcohols (perfluoro-alkylethanol) n:2 FTOH mixture are
considered to form not only a group of structurally related analogues,
but are also closely related based on metabolic pathway considerations.
For details see section 13 of this IUCLID document.
Justification for classification or non-classification
No data are available for the registration substance (target substance), but data are available for the read-across material, n:2 FTOH mixture (source substance). The source substance n:2 FTOH mixture has been evaluated in a developmental toxicity study and one-generation reproduction study in rats which are published in one paper.
Litter size at birth and number of live pups per litter on day 0 and 4 of lactation, were reduced in groups administered≥100 mg/kg bw/day. Pup weights during lactation were only significantly reduced at the top dose of 250 mg/kg/day. No other adverse reproductive parameters were affected.Mating and fertility indices were comparable across groups.Although signs of developmental toxicity at higher doses were observed, the test substance (source substance) was not embryo-lethal or teratogenic in rats at doses tested. Therefore, n:2 FTOH mixture was not considered toxic to the offspring.
Based hereupon, the test substance does not need to be classified for reproductive/developmental toxicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
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