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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 262-774-8 | CAS number: 61417-49-0
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Justification for type of information:
- Weight-of-Evidence approach has been applied to the target substance. As the target substance is hydrolytically unstable, the toxicity of the target substance lies in its hydrolysis products - isostearic acid and 2-propanol. The toxicity properties of both hydrolysis products have been well-investigated.
An adequate study based on human exposure to isostearic acid was available and conclusive. Therefore, according to column 2 of annex VII, an in vitro / in chemico study in unnecessary. - Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- The target substance is a hydrolytically unstable organotitatnate with hydrolysis half-life estimated to be with 1 hr, and with hydrolysis products being identified to be 2-propanol, isostearic acid and titanium dioxide. Because of the rapid hydrolysis, the influence of the target substance is related to the hydrolysis products.
Isostearic acid is the major hydrolysis product of the target substance. It’s toxicity property is used for read-across based on weight of evidence method. - Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of human data. Review of patch test data of humans following exposure
- GLP compliance:
- no
- Remarks:
- Non-GLP study that predates current guideline.
- Type of study:
- patch test
- Justification for non-LLNA method:
- Existing study conducted before REACH. Study conducted on human and adopted by peer-revieed journal.
- Species:
- other: human
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 35%
- Day(s)/duration:
- 3 week
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 35%
- Day(s)/duration:
- 3 week
- No. of animals per dose:
- 168
- Details on study design:
- Test material was applied at 48h intervals, 3 times per week for 3 weeks on the back of the subjects. The test area was occluded for 24 h before removal, and washed with distilled water.
Test sites were read at 48 h. - Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 35 %
- No. with + reactions:
- 0
- Total no. in group:
- 168
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 35%
- No. with + reactions:
- 0
- Total no. in group:
- 168
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- expert judgment
- Conclusions:
- Assessment of extensive human data showed that there is no indication of sensitisation protential.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- The target substance is a hydrolytically unstable organotitatnate with hydrolysis half-life estimated to be with 1 hr, and with hydrolysis products being identified to be 2-propanol, isostearic acid and titanium dioxide. Because of the rapid hydrolysis, the influence of the target substance is related to the hydrolysis products.
Isostearic acid is the major hydrolysis product of the target substance. It’s toxicity property is used for read-across based on weight of evidence method. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of human data. Review of patch test data of humans following exposure
- GLP compliance:
- no
- Remarks:
- Non-GLP study that predates current guideline.
- Type of study:
- patch test
- Justification for non-LLNA method:
- Existing study conducted before REACH. Study conducted on human and adopted by peer-revieed journal.
- Species:
- other: human
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 35%
- Day(s)/duration:
- 3 week
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 35%
- Day(s)/duration:
- 3 week
- No. of animals per dose:
- 168
- Details on study design:
- Test material was applied at 48h intervals, 3 times per week for 3 weeks on the back of the subjects. The test area was occluded for 24 h before removal, and washed with distilled water.
Test sites were read at 48 h. - Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 35 %
- No. with + reactions:
- 0
- Total no. in group:
- 168
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 35%
- No. with + reactions:
- 0
- Total no. in group:
- 168
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- expert judgment
- Conclusions:
- Assessment of extensive human data showed that there is no indication of sensitisation protential.
- Executive summary:
The study was conducted on isostearic acid, the strucural analogue and also the hydrolysis product of the target substance. As the target substance is hydrolytically unstable, its intrinsic property lies in the the hydrolysis products. The result is used as weight of evidence approach in hazard assessment.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No studies were conducted on the target substance “Reaction product of Titanium tetraisopropanolate and Isooctadecanoic acid”. As the substance is hydrolytically unstable, the toxicity of the target substance lies in its hydrolysis products.
According to extensive human exposure research, isostearic acid is found to be non-sensitising to skin (CIR, 1983). 2-propanol is also non-sensitising.
Based on above findings, the target substance is considered not skin sensitizing.
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.