Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 206-420-2 | CAS number: 338-83-0
- 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
Two studies investigating the reproductive or developmental toxicity potential of perfluoropropylamine (PTPA) have been conducted. The results of the studies are:
The No Observed Adverse Effect Level (NOAEL) is 1,000 mg/kg/day when tested according to OECD 421.
The No Observed Adverse Effect Level (NOAEL) is 1,000 mg/kg/day when tested according to OECD 414.
Additional information
Discussion:
The reproductive/developmental and repeated dose toxicity of the test article was evaluated in male and female Wistar Han rats. The study was conducted according to OECD 421 in compliance with OECD GLP regulations. Rats (10/sex/dose) were dosed with 0 (control), 100, 300, or 1000 mg/kg/day via oral gavage for a minimum of 28 days. The following parameters and end points were evaluated in this study: mortality/moribundity, clinical signs, body weight and food consumption, estrous cycle determination, measurement of thyroid hormone T4 (F0-males), gross necropsy findings, organ weights and histopathologic examinations. In addition, the following reproduction/developmental parameters were determined: mating and fertility indices, precoital time, number of implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development, mortality, clinical signs, body weights, sex, anogenital distance, areola/nipple retention and macroscopy, measurement of thyroid hormone T4 (PND 14-16 pups)). Due to a dosing error occurring during the pre-mating period of the study, the animals of low and mid dose groups had received at least five 5 times less than intended. The results of these two groups were, therefore, excluded from interpretation. No parental toxicity was observed at the highest dose tested (1000 mg/kg/day). No adverse treatment-related changes were noted in any of the parameters investigated in this study (clinical appearance, body weight, food consumption, T4 thyroid hormone levels (in males only), macroscopic examination, organ weights, and microscopic examination. No treatment-related changes were noted in any of the reproductive parameters investigated (mating and fertility indices, precoital time, number of implantations, estrous cycle, spermatogenic profiling, and histopathological examination of reproductive organs). No treatment-related changes were noted in any of the developmental parameters investigated in this study (gestation, viability and lactation indices, duration of gestation, parturition, sex ratio, maternal care and early postnatal pup development consisting of mortality, clinical signs, body weight, anogenital distance, areola/nipple retention, T4 thyroid hormone levels and macroscopic examination). Based on the results of the study, the parental and reproductive/developmental No Observed Adverse Effect Level (NOAEL) is 1000 mg/kg/day.
The prenatal developmental toxicity potential of the test article was evaluated in female Wistar Han rats. The study was conducted according to OECD 414 in compliance with OECD GLP regulations. Time-mated female rats (22/dose) were exposed from Day 6 to Day 20 post-coitum, inclusive, via oral gavage to 0 (control), 100, 300, or 1000 mg/kg/day test article. The following parameters and end points were evaluated in this study for the F0-generation: mortality/moribundity, clinical signs, body weights, food consumption, thyroid hormone levels (T3, T4, TSH), gross necropsy findings, number of corpora lutea, organ weights ((gravid) uterus and thyroid gland), uterine contents and histopathologic examination (thyroid gland). In addition, the following parameters were determined for the F1-generation: the number of live and dead fetuses, early and late resorptions, total implantations, fetal body weights, sex ratio, ano-genital distance, external, visceral and skeletal malformations and developmental variations. No maternal toxicity was observed in any dose group. No developmental toxicity was observed in any dose group. Based on the results of the study, the prenatal developmental No Observed Adverse Effect Level (NOAEL) is 1000 mg/kg/day.
Reproductive and developmental studies conducted on structural analogs indicate that the repro/dev profile is similar across the chemical category.
Effects on developmental toxicity
Description of key information
Two studies investigating the reproductive or developmental toxicity potential of perfluoropropylamine (PTPA) have been conducted. The results of the studies are:
The No Observed Adverse Effect Level (NOAEL) is 1,000 mg/kg/day when tested according to OECD 421.
The No Observed Adverse Effect Level (NOAEL) is 1,000 mg/kg/day when tested according to OECD 414.
Additional information
Discussion:
The reproductive/developmental and repeated dose toxicity of the test article was evaluated in male and female Wistar Han rats. The study was conducted according to OECD 421 in compliance with OECD GLP regulations. Rats (10/sex/dose) were dosed with 0 (control), 100, 300, or 1000 mg/kg/day via oral gavage for a minimum of 28 days. The following parameters and end points were evaluated in this study: mortality/moribundity, clinical signs, body weight and food consumption, estrous cycle determination, measurement of thyroid hormone T4 (F0-males), gross necropsy findings, organ weights and histopathologic examinations. In addition, the following reproduction/developmental parameters were determined: mating and fertility indices, precoital time, number of implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development, mortality, clinical signs, body weights, sex, anogenital distance, areola/nipple retention and macroscopy, measurement of thyroid hormone T4 (PND 14-16 pups)). Due to a dosing error occurring during the pre-mating period of the study, the animals of low and mid dose groups had received at least five 5 times less than intended. The results of these two groups were, therefore, excluded from interpretation. No parental toxicity was observed at the highest dose tested (1000 mg/kg/day). No adverse treatment-related changes were noted in any of the parameters investigated in this study (clinical appearance, body weight, food consumption, T4 thyroid hormone levels (in males only), macroscopic examination, organ weights, and microscopic examination. No treatment-related changes were noted in any of the reproductive parameters investigated (mating and fertility indices, precoital time, number of implantations, estrous cycle, spermatogenic profiling, and histopathological examination of reproductive organs). No treatment-related changes were noted in any of the developmental parameters investigated in this study (gestation, viability and lactation indices, duration of gestation, parturition, sex ratio, maternal care and early postnatal pup development consisting of mortality, clinical signs, body weight, anogenital distance, areola/nipple retention, T4 thyroid hormone levels and macroscopic examination). Based on the results of the study, the parental and reproductive/developmental No Observed Adverse Effect Level (NOAEL) is 1000 mg/kg/day.
The prenatal developmental toxicity potential of the test article was evaluated in female Wistar Han rats. The study was conducted according to OECD 414 in compliance with OECD GLP regulations. Time-mated female rats (22/dose) were exposed from Day 6 to Day 20 post-coitum, inclusive, via oral gavage to 0 (control), 100, 300, or 1000 mg/kg/day test article. The following parameters and end points were evaluated in this study for the F0-generation: mortality/moribundity, clinical signs, body weights, food consumption, thyroid hormone levels (T3, T4, TSH), gross necropsy findings, number of corpora lutea, organ weights ((gravid) uterus and thyroid gland), uterine contents and histopathologic examination (thyroid gland). In addition, the following parameters were determined for the F1-generation: the number of live and dead fetuses, early and late resorptions, total implantations, fetal body weights, sex ratio, ano-genital distance, external, visceral and skeletal malformations and developmental variations. No maternal toxicity was observed in any dose group. No developmental toxicity was observed in any dose group. Based on the results of the study, the prenatal developmental No Observed Adverse Effect Level (NOAEL) is 1000 mg/kg/day.
Reproductive and developmental studies conducted on structural analogs indicate that the repro/dev profile is similar across the chemical category.
Justification for classification or non-classification
The results of these studies indicate that perfluorotripropylamine (PTPA) does not meet the requirements to be classified for reproductive or developmental toxicity.
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.