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Diss Factsheets
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EC number: 947-785-4 | CAS number: -
- 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
The repeated administration in the repeated dose toxicity combined with reproductive endpoint study in rodent by oral application did not show any adverse systemic effects. NOAEL for systemic effects is considered to be 1000 mg/kg bw/day for males and females. Local effect were seen in lungs but considered an indirect effect due to suspected chemical pneumonitis. It is known that low viscosity chemicals can generate residues in the esophagus that can be aspired in the trachea and deposited in lungs creating such local inflammation as seen in the study. Dark material (the test material) seen in some animals in lung histiocytes do support such a conclusion.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylene-tetramine (TOFA-MA-TETA) and the source substance Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA) are characterised by the same starting materials: the hydrophobic part from fatty acids and the hydrophilic part from the polyethyleneamines.
The source substance is a mixture of ethyleneamines of different lengths (DETA, TETA and TEPA). The target substance contains only one ethyleneamine: TETA.
The source and the target substance show therefore the same reactive groups and a similar composition with the absence of two original ethyleneamines (DETA and TEPA) as biggest difference. A read-across to the source is therefore justified.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance actually is manufactured from the same starting materials of the source:
Fatty acids, tall-oil and maleic anhydride. TOFA is reacted with maleic anhydride to make a Diels-Alder intermediate which is a tri-acid. This is reacted with the TETA to produce a mixture of amido-amine & oligomeric UVCB constituents. The source substance also contains two other ethyleneamines: di-ethylenetriamine and tetraethylenepentamine.
The source substance has been registered already and based on the pathological evaluation, a No-Observed-Effect-Level (NOEL) could not be determined in the study submitted. The same conclusion is applied to the target substance.
3. ANALOGUE APPROACH JUSTIFICATION
The target substance is one of the constituent of the UVCB source substance and thus read-across from the bigger compound Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine to TOFA-MA-TETA is common practice and justified.
4. DATA MATRIX
Whereas the source substance is a Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA), hence using a mixture of DETA, TETA and TEPA as reactant, the target substance uses pure TETA (triethylenetetramine) instead, being a more purified (narrower cut distillation) form of DETA/TETA/TEPA resulting in a name change of the target substance, being Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine (TETA). - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Dose descriptor:
- NOEL
- Remarks on result:
- not determinable
- Dose descriptor:
- LOAEL
- Effect level:
- <= 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: NOAEL for systemic toxicty
- Critical effects observed:
- not specified
- Conclusions:
- In an OECD 422 study with the source substance fatty acids, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine test item-related histopathological changes were restricted to the lung, considered local but not systemic effects. No other findings were seen. Multifocal subacute bronchopneumonia, characterized by peribronchial foci of prominent fibrosis, with re-epithelialization, infiltration with mononuclear cells, histiocytes and occasional multinucleated cells, was observed in a small proportion of treated males and females of all dose groups, without any dose relationship. In addition, a mild amount of intrahistiocytic black material was seen in the lung of one male treated at 300 or and one male at 1000 mg/kg/day.
As a conclusion, based on the pathological evaluation, a No-Observed-Effect-Level (NOEL) could not be determined in this study, but a NOAEL for systemic toxicity was set to 1000 mg/kg bw/d.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In absence of systemic toxicity seen in the OECD 422 study in rats, the substance is not subject to classification for systemic target organ toxicity, repeat exposure, according to CLP (Regulation EC No 1272/2008).
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