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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
NOAEL(reproduction) = 1000 mg/kg bw/d (Reproduction / Developmental Toxicity Screening Test, OECD TG 421, rat m/f, oral: gavage), RL1; GLP; read-across: partially unsaturated TEA-Esterquat
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no signs of treatment-related toxicity
- Critical effects observed:
- no
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no signs of treatment-related toxicity
- Reproductive effects observed:
- no
- Conclusions:
- Based on the results obtained in this study, the NOAEL (No Observed Adverse Effect Level) for both general toxicity and reproduction/developmental toxicity was considered to be 1000 mg/kg/day for both males and females.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- 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
No experimental data are available for the assessment of reproduction toxicity of the target substance Esterification products of triglycerides C18 unsaturated with triethanolamine, dimethyl sulfate quaternized. 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.
The toxic effects on Sprague Dawley rats of both sexes were investigated after repeated dosing with the test item partially unsaturated TEA-Esterquat in accordance with OECD Guideline 421 (adopted 29 July 2016). Furthermore, effects of the test item on male and female reproductive performance were examined, i.e. gonadal function, mating behaviour, conception, parturition and early lactation of the offspring. The vehicle was water (was water softened by reverse osmosis. All doses (0, 100, 300 and 1000 mg/kg/day) were administered orally, by gavage at a dose volume of 10mL/kg body weight.
Males were treated for 14 days prior to pairing and during pairing with females until the day before necropsy, for a total of 30 days. Females were treated for 14 days prior to pairing, during pairing and throughout the gestation and lactation periods until Day 13 post partum.
The following investigations were performed: body weight, body weight gain, clinical signs, food consumption, macroscopic observations, organ weights and histopathological examination.
In addition the following assessments performed: oestrous cycle evaluation for parental females (2 weeks before start of dosing, during pre-mating and mating phases, prior to necropsy), mating performance, thyroid hormone determination (parental males and pups at Day 13/14 post partum) and collection of litter data.
Clinical signs, anogenital distance, external and/or internal examination were recorded for pups. Thyroid hormone levels and thyroid weight were also determined in 1 pup/sex/group randomly selected at Day 14 post partum.
Routine histopathological examination was performed only in control and high dose groups and it included identification of the stages of the spermatogenic cycle in male animals.
1.2 Fate of females
Details of the pregnancy status were as follows:
Groups 1 2 3 4
Non-pregnant females 0 0 0 0
Conceiving 1 - 5 days 10 10 10 10
No. of females with live pups on Day 13/14 post partum 10 10 10 10
1.3 Mortality and clinical signs
No mortality occurred during the study.
Salivation was the most relevant and treatment-related clinical sign recorded during the study. This sign was occasionally noticed in all males and females treated at 1000 mg/kg/day,
starting from the pre-mating phase until sacrifice (end of mating for males and post partum phase for females). Males treated at 300 mg/kg/day also showed salivation, but this sign
appeared later in the study, mostly at the end of the mating phase.
1.4 Body weight and body weight gain
No differences in body weight were observed in treated animals of both sexes, when compared to controls and no differences considered treatment-related were observed in body weight gain of treated animals.
1.5 Food consumption
Food consumption was unaffected by treatment.
1.6 Blood detection of test item
Systemic exposure of pups through the mother milk was also demonstrated by the presence of the physiological degradation product TEA-Core in pups on Day 13post partum, i.e. prior to weaning. However, quantification was not possible since the detected values of TEA-Core were below the limit of quantification (BLOQ).
1.7 Oestrous cycle, reproductive parameters, pairing combination and mating performance
Oestrous cycles, pre-coital interval, copulatory index and fertility index did not show any treatment-related intergroup differences.
1.8 Implantation sites, pre-implantation loss data, pre-natal loss data and gestation length of females
Implantation sites, pre-implantation and pre-natal loss and gestation length did not show treatment-related differences.
1.9 Litter data and sex ratio of pups
No significant differences in total and live litter size, pup loss, litter weights and mean pup weight were observed among treated and control females at birth and on Days 1, 4 and 13 post partum. Sex ratio did not show any significant differences between groups.
1.10 Clinical signs of pups
No signs considered treatment related were seen in pups of treated groups.
1.11 Anogenital distance
The statistically significant decrease noted in the ano-genital distance of male and female pups on Day 1 of age in all treated groups was considered incidental and unrelated to treatment, considering that: in both sexes all values were within the range of ERBC historical control data and there was no relation to the dose.
In addition, in females, the decrease observed represents a trend towards feminisation and is not considered an adverse effect (i.e. an increase in AGD of females, suggesting masculinisation); in males, there was no correlations with other findings considered androgen-mediated endpoints (such as areola/nipple retention, cryptorchidism, decreased reproductive organ weights, and malformation incidence).
1.12 Thyroid hormones
Parental animals
No differences were recorded between treated and control groups.
Pups - Day 14 post partum
No differences were recorded between treated and control groups.
1.13 Necropsy findings in decedent pups, in pups sacrificed on Days 4 and 13/14
post partumand nipple count
No findings were seen at necropsy in decedent pups or in those sacrificed on Days 4 and 13 post partum.
No nipples were observed in male pups on Day 13 post partum.
1.14 Pups thyroid weight on Day 13/14post partum
No significant differences were noted in thyroid weight between controls and pups of treated groups.
1.15 Terminal body weight and organ weights
No changes attributable to the treatment were observed in terminal body, absolute and relative organ weight of treated animals, when compared to the controls.
1.16 Macroscopic observations
No significant differences were noted at post mortem examination in treated animals, when compared to the controls.
1.17 Microscopic observations
No treatment-related changes were observed in treated animals, when compared to the controls.
Seminiferous tubules were evaluated with respect to their stage in the spermatogenic cycle and to the integrity of the various cell types within the different stages; regular layering in the germinal epithelium was noted.
Conclusion
In conclusion, no signs of treatment-related toxicity were observed at any of the dose levels investigated following treatment with the test item, when administered to rats by oral route at dose levels of 100, 300 and 1000 mg/kg/day. Based on the results of the present study, the NOAEL (No Observed Adverse Effect Level) for general, reproductive and developmental toxicity was considered to be 1000 mg/kg/day for males and females.
There are no data gaps for the endpoint reproduction 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.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, Esterification products of triglycerides C18 unsaturated with triethanolamine, dimethyl sulfate quaternized does not need to be classified for toxicity to reproduction according to regulation (EC) 1272/2008. Thus, no labelling 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.
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.