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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 234-679-1 | CAS number: 12023-27-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- no guideline available
- Guideline:
- other: Klecak G: Chapter 9 in "Advances in Modern Toxicology", Vol. 4, Dermatology and Pharmacology (ed. Marzulli and Maibach), 1977
- Principles of method if other than guideline:
- Guinea pigs are used for this test. During induction, the test item was topically applied to the shaved skin of the back of the animals once daily for a time period of 21 days. Challenges were performed on days 22 (Challenge I) and on day 36 (Challenge II). After challenge the animals were examined for skin reactions 24, 48 and 72 hours after administration.
- GLP compliance:
- yes
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- The test was conducted prior REACH came in force.
Test material
- Reference substance name:
- Diiron titanium pentaoxide
- EC Number:
- 234-679-1
- EC Name:
- Diiron titanium pentaoxide
- Cas Number:
- 12023-27-7
- Molecular formula:
- Fe2O5Ti
- IUPAC Name:
- titanium(4+) diiron(3+) pentaoxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Iva:PDH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: Mean initial body weight: 335 g
- Housing: individual in Makrolon cages type IV
- Diet: ad libitum, Altromin Standard Diet
- Water: ad libitum, tap water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 27
- Humidity (%): 39 - 45
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: HPMC (hydroxypropylmethyl cellulose)
- Concentration / amount:
- 30%
- Day(s)/duration:
- 21 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: HPMC (hydroxypropylmethyl cellulose)
- Concentration / amount:
- 3, 10 and 30%
- Day(s)/duration:
- Day 22
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: HPMC (hydroxypropylmethyl cellulose)
- Concentration / amount:
- 3, 10 and 30%
- Day(s)/duration:
- day 36
- No. of animals per dose:
- 6
- Details on study design:
- RANGE FINDING TESTS: A pretest to determine the threshold concentration after single application was done with 3, 10 and 30% preparations. The high concentration of 30% did not induce skin irritation and was therefore used as test concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 21 days
- Test groups: 0.1 mL of test material
- Control group: 0.1 mL af vehicle
- Site: shaven skin of the back
- Frequency of applications: daily
- Concentrations: 30% test material
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 22 and 36
- Test groups: 0.1 mL of test material
- Control group: 0.1 mL af vehicle
- Site: challenge I on left flank and challenge II on right flank
- Concentrations: 3, 10 and 30% test material preparations
- Evaluation (hr after challenge): 24,48 and 72 h
Three groups with 6 female guinea-pigs, each, were investigated: Group 1(untreated control), group 2 (vehicle control) and group 3 (treatment group). Group 3 was topically treated with 0.1 mL of 30% test material (Induction) daily for 21 days to the shaven skin of the back. Challenges were performed 1 and 15 days after the last treatment. Each animal of all 3 groups was challenged with 3 different test material concentrations (3, 10 and 30% test material preparations). Half of the untreated control animals (group 1) were treated on the first challenge and the rest on the second challenge with the test material preparations and the vehicle to exclude primary irritation. During the induction phase the animals were investigated for skin reactions daily, about 24 h after application of the test material always. After challenge they were examined 24, 48 and 72 hours after administration. The skin reactions were classified as
0 = negative/questionable
+ = positive - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no clinical effects observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no clinical effects observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no clinical effects observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no clinical effects observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no clinical effects observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no clinical effects observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no clinical effects observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no clinical effects observed
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the substance is not considered to be a skin sensitizer.
- Executive summary:
The test item was tested for skin sensitizing activity in guinea pigs in the Open Epicutaneous Test (OET). Three groups with 6 female guinea pigs each were investigated: Group 1 (untreated control) and group 2 (vehicle control) were treated to exclude primary irritation. Group 3 was treated with 0.1 mL of 30% test material suspension (induction). During the induction period (21 days of daily treatment) brown discoloration was observed at the treated skin.
After the first and second challenge (performed at the flanks on days 22 and 36 of the study, respectively) with test material concentrations of 3, 10, and 30%, none of the different challenge sites in any of the guinea pigs showed a positive skin reaction. Under the experimental conditions given, the test item is classified as a non-sensitizer.
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.