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EC number: 234-456-9 | CAS number: 12004-39-6
- 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
Guideline-compliant studies of eye and skin irritation are available.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5th March 2012 to 15th June 2012.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with relevnat OECD Guidelines and GLP compliance, with no deviations likely to affect the integrity of the study.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 18 weeks old.
- Weight at study initiation: 3.25 - 3.7kg
- Housing: Housed individually in aluminium cages (W 360 x D 550 x H 350mm) with wire mesh bottoms.
- Diet (e.g. ad libitum): Free access to RC4 pelletd diet (Oriental Yeast Co., Ltd., Lot numbers 111212 and 120113) ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: Animal for the first application was acclimated for 12 days. Animals in the second application were acclimated for 14 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5°C
- Humidity (%): 55 ± 25%
- Air changes (per hr): 11 to 14 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light (light period from 07:00 to 19:00) - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g of the test material was moistened with 0.5 mL of water for injection.
- Duration of treatment / exposure:
- In Application 1, the exposure period for step 1 was 3 minutes, for step 2 was 1 hour and for step 3 was 4 hours. In Application 2, the exposure period was for 4 hours.
- Observation period:
- The test sites for the 1 and 4 hour exposure periods were examined at 1, 24, 48 and 72 hours after removal of the the test material and the skin irritation/corrosion potential of the test material was determined.
In Application 1, the test site of the test animal used in steps 1 to 3 were observed for effects of skin corrosivity immediately after removal of the test test material. For the 3 minute exposure in Application 1, Step 1, the exposure site was observed at 1 and 24 hours after removal of the application.
Clinical observations were conducted immediately after removal of the test material and again after 1 hour for the test animal used in Step 1 to 3 of Application1.
For the two test animals in Application 2, observations for clinincal signs of toxicity were made immedaitely and at 1, 4 and 5 hours after the test material was applied. The day following application and thereafter, each animal was observed once daily up to the day of final observation (day 3 after application).
All test animals were weighed on the day of application and on the final day of observation. - Number of animals:
- First application: 1 animal
Second application: 2 animals. - Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the animal, approximately 2.5 cm x 2.5 cm.
- Type of wrap if used: The test material was applied to a lint patch lined with oil paper. The patch was applied to the application site and covered with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The areas of exposure were wiped with absorbent cotton soaked with water.
- Time after start of exposure: In the first application, for step 1, the test material was removed after 3 minutes exposure, in step 2, the material was removed after 1 hour exposure and in step 3, the material was removed after 4 hours exposure.
In the second application, the treated areas were wiped after 4 hours exposure to the test material.
SCORING SYSTEM: Scored according to Draize Criteria (1959). - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: No effects were observed at any time point, in any animal
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: No effects were observed at any time point, in any animal
- Irritant / corrosive response data:
- In Application 1, step 1, after 3 minutes exposure, no corrosive change was observed immediately after removal of the test application. No skin reactions including erythema or oedema were observed at 1 or 24 hours after removal of the test material.
In Application 1, step 2, after 1 hour exposure, no corrosive change was observed immedaitely after removal of the test application. No skin reactions including erythema or oedema were observed at 1, 24. 48 or 72 hours after removal of the test material.
In Application 1, step 3, after 4 hours exposure, no corrosive change was observed immedaitely after removal of the test application. No skin reactions including erythema or oedema were observed at 1, 24. 48 or 72 hours after removal of the test material. Individual mean values at 24, 48 and 72 hours after removal of the application was 0.
In Applicaiton 2, step 4, after 4 hours exposure, no corrosive change was observed immedaitely after removal of the test application. No skin reactions including erythema or oedema were observed at 1, 24. 48 or 72 hours after removal of the test material. Individual mean values at 24, 48 and 72 hours after removal of the application was 0 for each animal. - Other effects:
- No abnormal clinical signs were observed in any test animal during the observation period.
No abnormalities in body weight gain were observed in any animal during the observation period. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material, Aluminium titanium oxide was not considered to be irritating or corrosive.
- Executive summary:
In a study conducted to determine the potential of aluminium titanium oxide to cause skin irritation or corrosion, a study was conducted in Japanese White rabbits in accordance with OECD Guideline 404 and GLP. There were no signs of irritation or corrosion observed at any of the time-points investigated.
Reference
No additional information.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 5th, 2012 to June 15th, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with GLP and the applicable OECD guideline with no deviations.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 16 weeks old.
- Weight at study initiation: 2.82 - 3.01kg
- Housing: Animals were individually housed in aluminium cages (W 360 x D 550 x H 350mm) with wire mesh bottoms.
- Diet (e.g. ad libitum): RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot No's 111212 and 120113) ad libitum.
- Water (e.g. ad libitum): Tap Water ad libitum.
- Acclimation period: 21 days acclimation period for the animal in the 1st application and 23 days acclimation for the animals in the 2nd application.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5°C (measured values 20 to 27°C)
- Humidity (%): 55 ± 25% (measured values 36 to 59%)
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12 hors light per day (07:00 - 19:00) - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye of each test animal served as control.
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- For the 1st and 2nd step, a single application of the test material was applied to the conjunctival sac of the left eye.
- Observation period (in vivo):
- Observations were made at 1, 24, 48 and 72 hours after application.
- Number of animals or in vitro replicates:
- In the 1st step, one female test animal was used. In the 2nd step, 2 female test animals were used.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Test material was not removed at completion of the exposure period.
SCORING SYSTEM:
The scoring system to assess ocular lesions was Draize Criteria (1959)
Eye irritation effects were evaluated according to the method of Kay and Calandra.
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: No effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Grade 1 effects were observed only at the one-hour observation and had resolved in all animals by 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: No effects observed
- Irritant / corrosive response data:
- No corrosive changes such as necrosis, ulcer or haemorrhage from 1 to 72 hours after application were observed in any animal. Conjunctival redness in animals and discharge in 1 animal were observed at 1 hours application (MTS: 2.7), however, these conjunctival changes had disappeared by 24 hours after application. No irritation reactions were observed in the cornea, iris or conjunctiva of any animal at either 24, 48 or 72 hours after application. In the corneal examination which was performed at 24hours after application, no fluoroscein stainnig marks were observed in any animal.
No abnormalities were observed in the control eye of any test animal. - Other effects:
- No abnormal clinical signs were observed in any animal during the 72 hour observation period.
No abnormalities in body weight gain were observed in any animal during the observation period. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was found to be a minimal eye irritant under the conditions of this study.
- Executive summary:
In a study to determine the potential of aluminium titanium oxide to cause irritation or corrosion to the eyes of female Japanese white rabbits. The study was conducted according to GLP and OECD Guideline 405. Conjunctival redness was observed in all animals and discharge in one animal 1 hour after application, however, these conjuctival changes had disappeared 24 hours after application. There were no irritation reactions observed in the cornea, iris or conjunctiva of any animal at either 24, 48 or 72 hours after application.
The test material was found to be a minimal eye irritant under the conditions of this study.
Reference
Observation |
1h |
24h |
48h |
72h |
Mean (24-72h) |
|
Cornea |
Opacity |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Iris |
Lesion |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Conjunctivae |
Erythema |
1.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Oedema |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study of skin irritation in the rabbit did not reveal any local effects in any animal at any timepoint. A study of eye irritation in the rabbit shows minimal transient conjunctival erythema.
Justification for selection of skin irritation / corrosion endpoint:
Only one study is available for this endpoint.
Justification for selection of eye irritation endpoint:
Only one study is available for this endpoint.
Justification for classification or non-classification
The results of the skin and eye irritation studies do not trigger classification for skin or eye irritation according to DSD or the CLP Regulation.
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.
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