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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 410-660-5 | CAS number: 1072830-14-8
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test guideline (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only limited details provided in NONS summary
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 410-660-5
- EC Name:
- -
- Cas Number:
- 1072830-14-8
- Molecular formula:
- Not Applicable for UVCB substance
- IUPAC Name:
- 1-[bis(2-hydroxypropyl)amino]propan-2-ol 2-(rutherfordiooxy)ethan-1-ol 2-hydroxypropanoic acid amine titanium
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on exposure:
- Method of administration or exposure: Gavage
Mass median aerodynamic diameter: Not applicable - Frequency of treatment:
- Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week
- No. of animals per sex per dose:
- Male: 28 animals at 0 mg/kg or mg/l
Male: 28 animals at 60 mg/kg or mg/l
Male: 28 animals at 300 mg/kg or mg/l
Male: 28 animals at 1200 mg/kg or mg/l
Female: 28 animals at 0 mg/kg or mg/l
Female: 28 animals at 60 mg/kg or mg/l
Female: 28 animals at 300 mg/kg or mg/l
Female: 28 animals at 1200 mg/kg or mg/l
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
At 1200 mg/kg 3 animals (2 males, 1 female) died as a result of dosing trauma.
At 300 mg/kg two females were found dead and one female was killed in extremis during the maturation phase of the study.
The deaths were consistent with dosing trauma.
At 30 mg/kg one male was killed in extremis during the mating phase of the study. Diuresis was observed on the day of termination. Post mortem observations included distension with haemorrhagic walls of the urinary bladder. In addition the prostrate was oedematous.
One female was killed in extremis during the lactation phase of the study. The deaths was consistent with dosing trauma.
At 0 mg/kg one male was killed in extremis during the post maturation phase of the study. On the day of termination there was clinical evidence of respiratory distress. Post mortem examination showed a jellified mass within the thorax.
Clinical observations:
There were no treatment-related clinical signs observed during the course of the study.
Bodyweight:
There were no significant treatment-related intergroup differences in male or female bodyweight gain.
Food consumption:
There were no significant treatment-related intergroup differences in male or female food consumption or food conversion.
Ophthalmoscopy:
There were no findings observed for selected males or females, either pretest or during week 10 of the study.
Laboratory Investigations:
Haematology:
There were no toxicologically significant intergroup differences in male or female blood haematological values.
Blood Chemistry:
There were no toxicologically significant intergroup differences in male or female blood chemistry values.
Reproductive Performance:
Fertility:
There were no significant treatment-related effects upon male or female mating or conception rates. The majority of pre-coital intervals were within the normal four to five day period. The distribution of pre-coital intervals were comparable for all groups.
Gestation and Parturition:
There were no significant treatment-related effects on the gestation or parturition indices. The distribution of gestation lengths were comparable for all groups, with the majority of gestation lengths being between twenty-two and twenty-three days.
Post Mortem Studies:
Necroscopy Findings:
There were no significant treatment-related intergroup differences in the type ro incidence of macroscopic anomalies observed for both males and females. The types of anomaly observed were those typically observed for this type of study.
Organ Weights:
There were no significant treatment-related intergroup differences for organ weights.
Histopathology:
At 1200 mg/kg there was a treatment-related effect on the stomachs of both males and females. Within the forestomach, subepithelial cell infiltrates, occasionally with associated acanthosis of the limiting ridge was observed. With the glandular stomach there was an increased incidence and
severity of agglomeration of secretion and goblet cell hyperplasia.
At 300 and 60 mg/kg there were no treatment-related effects on the stomach.
All the remaining morphological changes were those commonly observed in laboratory maintained rats of this age and strain.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- ca. 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOEL
- Remarks:
- For reproductive performance
- Effect level:
- > 1 200 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
Results: F1 generation
Details on results (F1)
Litter Size, Sex and Offspring Viability:
There were no siginificant treatment-related intergroup
differences in the mean total number of offspring born.
Subsequent offspring viability throughout lactation was
comparable for all groups including controls. There were no
significant intergroup differences in the offspring sex
ratios at either days 1 or 21 of lactation.
Offspring Clinical Condition:
There were no significant treatment-related intergroup
differences in the type and incidence of clinical signs
observed for offspring throughout lactation. The clinical
signs were those commonly observed in this type of study.
Offspring Bodyweight and Development:
There were no significant treatment-related intergroup
differences in both the mean total litter weight or mean
individual offspring bodyweight throughout lactation. There
were no significant treatment-related intergroup differences
in offspring maturation, as denoted by the onset and
completion of landmarks of development, throughout
lactation.
Offspring Reflexological Assessment:
There were no significant treatment-related intergroup
differences in offspring reflexological responses.
Offspring Necroscopy Findings:
There were no significant treatment-related intergroup
differences in the incidence and type of observations seen
at post mortem examination of offspring from either the
imterim and terminal necroscopy. The type of findings are
those commonly observed for this study type.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- At a dose level of 1200 mg TILCOM AT35/kg bodyweight there was a minor histopathological effect upon the stomachs of both males and females. There was no effect on either sex during the in-life phase of the study and no effect on either reproductive performance or offspring growth and survival. The no effect level for adult toxicity was therefore 300 mg TILCOM AT35/kg bodyweight. The no effect level for reproductive performances was in excess of 1200 mg TILCOM AT35/kg bodyweight.
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.