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EC number: 260-982-3 | CAS number: 57843-53-5
- 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
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- A deduction from Klimisch 1 (reliable without restrictions) to Klimisch 2 (reliable with restrictions) was made to appreciate read-across uncertainties.
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source substance N,N,N',N'-tetrakis(2-hydroxyethyl) hexanediamide (EC 405-370-0) used for read-across and the target substance N,N,N',N'-tetrakis(2-hydroxypropyl) hexanediamide (EC 260-982-3) do share a common functional group (two bis 2-hydroxyalkylamide functions) and both are manufactured by reacting a hexanedioic acid through an amidation reaction with either bis-2-hydroxyethyl amine or bis-2-hydroxypropyl amine to a N,N,N',N'-tetrakis(2-hydroxyalkyl) hexanediamide (see also attached file "Comparison_Hydroxypropyl_Hydroxyethyl_20221121.pdf").
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Data derived with the source substance N,N,N',N'-tetrakis(2-hydroxyethyl) hexanediamide (EC 405-370-0) are used for read-across to the target substance N,N,N',N'-tetrakis(2-hydroxypropyl) hexanediamide (EC 260-982-3) as outlined and justified in the attached file "Comparison_Hydroxypropyl_Hydroxyethyl_20221121.pdf". Purity and impurity profile of source and target substance are absolutely comparable.
3. ANALOGUE APPROACH JUSTIFICATION
Please see attached file "Comparison_Hydroxypropyl_Hydroxyethyl_20221121.pdf"
4. DATA MATRIX
Please see attached file "Comparison_Hydroxypropyl_Hydroxyethyl_20221121.pdf" - Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Dose descriptor:
- NOAEL
- Effect level:
- 20 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 20 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Reproductive effects observed:
- not specified
- Conclusions:
- No treatment related reproductive toxicity was observed when rats were exposed to the test article N,N,N',N'-tetrakis(2-hydroxyethyl) hexanediamide in the diet at concentrations up to and including 20,000 ppm (>1000 mg/kg/day). These results are considered adequate also for the structurally similar substance N,N,N',N'-tetrakis(2-hydroxypropyl) hexanediamide.
- Executive summary:
The purpose of this study was to investigate the effects of N,N,N',N'-tetrakis(2-hydroxyethyl) hexanediamide on growth, development and reproductive performance in male and female rats through production of one generation of offspring.
Based on the results of a preliminary range-finding study in male rats, a limit concentration of 20’000 ppm (target dose of 1’000 mg/kg) test article was selected as the high dose level for the reproductive study. Rats were exposed to test article in the diet at concentrations of 0, 1’000, 4’500 and 20’000 ppm beginning at approximately six weeks of age. Animals were mated after eleven weeks of exposure; treatment continued throughout gestation, lactation, and until terminal necropsy. No treatment-related effects on mortality, body weight or feed consumption were observed in either sex.
There were no treatment-related effects on any reproductive endpoints including number of litters produced, gestation length, mating and fertility indices (in both sexes), and gestation index. There were no treatment-related effects on number of live born or stillborn pups per litter, postnatal survival viability and lactation indices or growth. No treatment-related gross findings were observed in the parental animals or offspring at any dose. In addition, no treatment-related microscopic changes were observed in the organs examined from parental animals treated with 20’000 ppm. At 20’000 ppm, indications of toxicity were limited to soft and/or irregular feces in both sexes. Based on the available data, it is concluded that reproductive toxicity was not observed at doses up to and including 20’000 ppm.
Considering the structural similarity and comparable purity/impurity profile as well as phys-chem and tox data to N,N,N',N'-tetrakis(2-hydroxypropyl) hexanediamide, it is justified to read-across same finding to this target substance.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
As the proportion of test item having an inhalable particles size of less than 100 µm was determined to be 7.32%, it is reasonable to expect that the inhalation route will not be a significant exposure route to the test material. Thus, there is no safety assessment concern for this route. As oral route is considered to be the most likely exposure, there is no safety assessment concern for dermal route.
The test substance N,N,N',N'-tetrakis(2-hydroxyethyl) hexanediamide is accepted as the structural analogue of target substance N,N,N',N'-tetrakis(2-hydroxypropyl) hexanediamide. A one-generation study (D.L Shuey, 1994) was available for read-across to investigate the effects of the test substance N,N,N',N'-tetrakis(2-hydroxyethyl) hexanediamide on growth, development and reproductive performance in male and female rats through production of one generation of offspring.
Based on the results of a preliminary range-finding study in male rats, a limit concentration of 20’000 ppm (target dose of 1’000 mg/kg) test article was selected as the high dose level for reproductive study. Rats were exposed to the test article in the diet at concentrations of 0, 1’000,4’500 and 20’000 ppm beginning at approximately six weeks of age. Animals were mated after eleven weeks of exposure; treatment continued throughout gestation, lactation, and until terminal necropsy. No treatment-related effects on mortality, body weight or feed consumption were observed in either sex.
There were no treatment-related effects on any reproductive endpoints including number of litters produced, gestation length, mating and fertility indices (in both sexes), and gestation index. There were no treatment-related effects on number of live born or stillborn pups per litter, postnatal survival viability and lactation indices) or growth. No treatment-related gross findings were observed in the parental animals or offspring at any dose. In addition, no treatment-related microscopic changes were observed in the organs examined from parental animals treated with 20’000 ppm. At 20’000 ppm, indications of toxicity were limited to soft and/or irregular feces in both sexes. Based on the available data, it is concluded that reproductive toxicity was not observed at doses up to and including 20’000 ppm. Therefore, it is concluded that the NOAEL of target article for the reproductive toxicity is 1’000 mg/kg bw/day resulting from this one-generation reproductive toxicity study.
Short description of key information:
No treatment related reproductive toxicity was observed when rats were exposed to test article in the diet at concentrations up to and including 20’000 ppm (1’000mg/kg bw/day).
Effects on developmental toxicity
Description of key information
There was no evidence on developmental toxicity at dosage levels up to 1’000 mg/kg bw/day from the one-generation reproductive toxicity study.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available (further information necessary)
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
Developmental toxicity information was present from the one-generation toxicity study.
In this study, there were no treatment-related effects on any reproductive endpoints including number of litters produced, gestation length, mating and fertility indices (in both sexes), and gestation index. There were no treatment-related effects on number of live born or stillborn pups per litter, postnatal survival viability and lactation indices) or growth. No treatment-related gross findings were observed in the parental animals or offspring at any dose. In addition, no treatment-related microscopic changes were observed in the organs examined from parental animals treated with 20’000 ppm. At 20’000 ppm, indications of toxicity were limited to soft and/or irregular feces in both sexes. Based on the available data given in one-generation toxicity study, it is concluded that there was no evidence of developmental toxicity observed at doses up to and including 20’000 ppm under this experimental conditions.
Justification for classification or non-classification
In absence of reproductive toxicity effects, no classification of the substance according to CLP (Regulation 1272/2008) is required.
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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