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EC number: - | 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
90 d NOAEL = 300 mg/kg bw/d (subchronic (90 day) repeated dose toxicity study, OECD TG 408, rat m/f, oral: gavage), RL1; GLP; read-across: partially unsaturated TEA-Esterquat
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic 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
This read-across is based on the hypothesis that source and target substances have similar (eco)toxicological properties because
• they share structural similarities with common functional groups: One quaternised ethanolamine moiety, one to three, mainly two ester groups with a typical UVCB distribution with long-chain fatty acids of natural origin. The molecular structure is almost identical.
• they are manufactured from similar resp. identical precursors (triethanolamine, long-chain fatty acids, dimethyl sulphate) under similar conditions. Therefore common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident
• A constant pattern in the changing of the potency of the properties across the TEA-Esterquats by chain-length and the grade of esterification is not observed, because the fatty acid chain-length distribution is too narrow and similar and the distribution of mono-, di-, and tri-esters is identical. Some variation caused by variation in C=C double bonds may occur and will be discussed at the relevant endpoint.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See general justification for read-across attached to chapter 13 of this IUCLID file.
3. ANALOGUE APPROACH JUSTIFICATION
See general justification for read-across attached to chapter 13 of this IUCLID file.
4. DATA MATRIX
See general justification for read-across attached to chapter 13 of this IUCLID file. - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see "Remarks"
- Remarks on result:
- other: 90 day study
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: highest tested dose, no treatment related effects et all
- Remarks on result:
- other: 28 d study
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- System:
- urinary
- Organ:
- bladder
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- yes
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- other: forestomach
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- no
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subchronic
- 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
No experimental data are available for the assessment of repeated dose toxicity of the target substance C18 and C18 unsatd. TEA-Esterquat. However, reliable relevant data are available for the closely related source substance partially unsaturated TEA-Esterquat. A justification for read-across is attached to iuclid section 13.
In a subchronic toxicity study according to OECD guideline 407 (1995) and EU method B7 (1996) the test substance partially unsaturated TEA-Esterquat, was administered to 5 CD rats/sex/dose by gavage at dose levels of 0,100, 300 and 1000 mg/kg bw/day for 28 days. A satellite group of 5 males and 5 female for the control and high dose group was included to assess the reversibility of any effects after a 2-week recovery period.
No mortality and no influence on behavior, external appearance, body weight, food and drinking water consumption, the eyes or optic region, the haematological and clinical-biochemical parameter and the relative or absolute organ weights at any of the tested dose levels was noted. No test item-related changes were revealed during neuropharmacological functional observations in any of the dosed groups.
Macroscopic post mortem examination and histopathology including the reproductive organs (epididymis, ovary, prostate, testicle and uterus) revealed no test item related changes in treated animals. There is no evidence for a specific target organ toxicity in this study.
Under test conditions, the NOAEL was above 1000 mg/kg bw /day in this 4- week subchronic toxicity study.
The analytical verification of dosing solutions demonstrated agreement of actual initial concentrations with nominal test concentrations.
In a subchronic toxicity study comparable to OECD guideline 408 (1981) partially unsaturated TEA-Esterquat was administered to 10 Sprague-Dawley rats/sex/dose by gavage at dose levels of 0, 100, 300 and 1000 mg/kg bw/day. The animals were treated 5 days/week and received in total 68 or 69 applications (depending on section date). Study performed according to the OECD guideline 408 of 1981, which allowed for exposure during working days, only, and stalling exposure at weekends. A satellite group of 5 males and 5 female for the control and high dose group was included to assess the reversibility of effects after a 35 day recovery period.
In the experimental animals no clinical effects and no impairment of body weight gain, food and water consumption, hematological parameters, organ or body weights related to the test substance administration were seen. The examination of the eyes with a slit lamp microscope showed no test substance related effects. The interpretation of this study is somewhat hampered due the occurrence of a bacterial infection (Tyzzer´s Disease induced by Clostridium piliforme) in all dose groups, including control and recovery group. Macroscopic or microscopic findings in the mandibular lymph node and the liver in all dose groups including the control were judged as directly related to this infection. Bacterial foci were detected in the liver.
Apart from these effects, animals of the high dose groups displayed potentially substance related increases of the activity of the alanine transaminase (ALT) in blood serum, signs of forestomach irritation and regressive epithelial changes in the urine bladder. However, an interaction with the bacterial infection cannot be entirely excluded. The significant increase of the ALT-values in the male and female animals of the high dose group was considered by the study author to be indicative for substance related liver effects. However, a confounding effect by the infection with Clostridium piliforme is likely. Beside the intestines and the myocardium, the liver is a common target organ of an infection by Clostridium piliforme (Tyzzer´s Disease). Typical degenerative histopathologic findings associated with the infection were seen in all dose groups and the control.
An induction of the enzyme alanine aminotransferase as a marker of liver damage in addition to these histopathologic alterations was evident. The histopathologic liver findings as well as the induction of the enzyme ALT - commonly associated with pathological liver alterations – are most likely due to the infection with Clostridium piliforme might have been intensified by the substance application. The observed edema of the forestomach mucosa in 2/9 male and 3/10 female animals of the highest dose group were considered to be a reaction due to irritating properties of the test substance observed in some (but not all) skin and eye irritation studies. The animals of the high dose recovery group were free of any forestomach findings, 35 days after termination of the treatment. Forestomach findings related to an irritant activity of the test item are common findings in rat gavage studies. They are attributable to the specific anatomy of the test species and the non-physiological bolus application by gavage and therefore judged as not relevant in view of a potential serious health risk for humans.
In 6/9 male animals of the high dose group the urinary bladder showed increased desquamation and localized regressive changes of the epithelium. The effects on the urinary bladder epithelium were considered by the study author to be a result of local physiological accumulation of the test compound or possible metabolites. A complete reversibility of the urinary bladder effects has been seen in the high dose recovery 35 days group. Therefore, the effects on the urinary bladder epithelium seen only in the high dose male animals can be judged as transient and do not pose a severe adverse health risk relevant to humans.
The histological examination of the reproductive organs (testes, epididymis, prostata, seminal vesicle, ovary and uterus) did not reveal any treatment related abnormalities.
On the basis of this study, a NOEL of 300 mg/kg bw/day for partially unsaturated TEA-Esterquat (90 % a.i.) can be derived.
There are no data gaps for the endpoint repeated dose toxicity. No human data are available. However, there is no reason to believe that these results from rat and rabbits would not be applicable to humans.
Similar results were obtained with the source substance MDEA-Esterquat C16-18 and C18 unsatd.: one 28 day repeated dose study comparable to OECD Guideline 407 and one sub-chronic toxicity study comparable to OECD Guideline 408 are available for the oral route of administration. The no effect level (NOEL) was determined to be 500 mg/kg/day (highest dose tested) for both studies. These data are included into the dossier to demonstrate, that the substances have a similar toxicological profile.
Justification for classification or non-classification
Based on the available data, C18 and C18 unsatd. TEA-Esterquat does not need to be classified for repeated dose toxicity according to regulation (EC) 1272/2008. Thus, no labelling is required.
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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