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Diss Factsheets
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EC number: 401-100-0 | CAS number: 109037-78-7 TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
- 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
Results of a Repeated Dose Toxicity Study Oral are reported. A testing proposal for a Sub-Chronic Toxicity Study Oral is also provided.
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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 160 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 160 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Eight animals (low dose - 1 male, middle dose - 1 male, 2 female, high dose - 1 male, 3 female) were found dead or killed in extremis.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Eight animals (low dose - 1 male, middle dose - 1 male, 2 female, high dose - 1 male, 3 female) were found dead or killed in extremis.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gain was lowered for males (wees 1 and 2) and females (weeks 1 - 4) in the high dose group.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Effects in organs:
No treatment related effects were seen at necropsy or on
histological examination. - Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 0 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Critical effects observed:
- not specified
- Conclusions:
- Substance is not classified
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS - This testing proposal is submitted following ECHA communication number : SUB-C-2114357560-51-03/F
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Butyl(dialkyloxy(dubutoxyphosphoryloxy)titanium(trialkyloxy) titanium phosphate
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: See attached Testing Proposal for further details.
• Acute toxicity: oral
• Acute toxicity: demal
• Skin irritation: in vivo
• Eye irritation: in vivo
• Skin sensitisation: in vivo (non-LLNA)
• Short-term repeated dose toxicity: oral
• In vitro gene mutation study in bacteria
• In vitro cytogenicity / chromosome aberration study in mammalian cells
• In vitro gene mutation study in mammalian cells
• Screening for reproductive / developmental toxicity
- Available non-GLP studies: No further studies available
- Historical human data: No further data available
- (Q)SAR: There are no adequately validated (Q)SAR models to address the endpoint; see attached Testing Proposal for further details.
- In vitro methods: There are no validated and regulatory accepted in vitro methods to address this endpoint.
- Weight of evidence: There is an insufficient weight of evidence from several independent sources to address the endpoint, see attached Testing Proposal for further details.
- Grouping and read-across: There is an unacceptable level of uncertainty regarding identification and selection of structurally and/or mechanistically related source substances; see attached Testing Proposal for further details.
- Substance-tailored exposure driven testing: The registered substance is only handled in industrial or commercial installations using closed systems and/or handled only as preparations at low concentrations, a sub-chronic study should be considered; see attached Testing Proposal for further details.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Annex IX Column 2 specific rules for adaptation for this endpoint are not applicable for the registered substance:
• the available short-term toxicity study results do not show severe toxicity effects according to the criteria for classifying the substance as R48;
• a reliable chronic toxicity study is not available;
• while the substance is subjected to solvolysis, and, in the presence of water polymeric complexes are formed, there is insufficient data on the cleavage products; and
• the substance is reactive with water forming polymeric complexes.
Annex XI general rules for adaptations of the standard testing regime are not applicable for the registered substance; specifically:
• Use of existing data:
Existing data does not address the endpoint, see attached Testing Proposal for further details;
• Weight of evidence:
There is an insufficient weight of evidence from several independent sources to address the endpoint, see attached Testing Proposal for further details;
• Qualitative or quantitative structure-activity relationship ((Q)SAR):
There are no adequately validated (Q)SAR models to address the endpoint, see attached Testing Proposal for further details;
• In vitro methods:
There are no validated and regulatory accepted in vitro methods to address this endpoint;
• Grouping of substances and read-across approach:
There is an unacceptable level of uncertainty regarding identification and selection of structurally and/or mechanistically related source substances, see attached Testing Proposal for further details;
• Testing is not technically possible:
It is technically possible to assess the registered substance for this endpoint; and
• Substance-tailored exposure-driven testing:
The registered substance is only handled in industrial or commercial installations using closed systems and/or handled only as preparations at low concentrations, a sub-chronic study should be considered, see attached Testing Proposal for further details.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
As there were difficulties associated with the administration of the registered substance during both the 28-day and the reproduction/developmental toxicity screening studies, the administration methods employed should be scrutinized to ensure the most accurate and humane method is employed during the proposed 90-day oral repeated dose study. See attached Testing Proposal for further details and special features to be included in the study design. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- See attached Testing Proposal for further details and special features to be included in the study design
- Species:
- rat
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 400 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
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.