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Diss Factsheets
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EC number: 208-909-6 | CAS number: 546-68-9
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-dates GLP and pre-dates current guideline. Similar to OECD 404 but reversibility not fully investigated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register No. 38. 187 § 1500.41 (skin) side of 27 27 019 Sept. 1973 evaluation key to Draize, J.H. (1959) DERMAL TOXICITY
- Deviations:
- not specified
- Principles of method if other than guideline:
- Study method was similar to OECD 404, Acute Dermal Irritation/Corrosion. Testing was performed on 6 New Zealand White rabbits on both abraded and unabraded skin sites with occlusive dressings. Treatment was for 24 hours. Following removal of the patches the animals were scored for erythema and eschar formation and oedema according to the grading system in OECD 404 at 24 and 72 hours post dose. The animals were killed 7 days post dose and a necropsy examination of the skin performed.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Titanium tetraisopropanolate
- EC Number:
- 208-909-6
- EC Name:
- Titanium tetraisopropanolate
- Cas Number:
- 546-68-9
- Molecular formula:
- C12H28O4Ti
- IUPAC Name:
- titanium tetraisopropanolate
- Details on test material:
- The test material was a liquid. Lot or batch number was not specified. Inbifo number was S 2575 A1. Purity was not specified.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Six male and female NZW rabbits were acclimatised for more than 3 days before the start of the study. The animals weighed 3 to 4 kg. They were housed in a permanent building, fully air-conditioned with filtered air. There was a 12 hour light/dark light cycle from 07:00 am to 19:00 pm. The temperature was 22+/- 1 degree C and the humidity was 55 +/- 10%. The animals were housed in stainless steel cages without litter. Standard laboratory pelleted diet and tap water were available ad-libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Test site was shaved and both abraded and non-abraded skin tested.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin on test animals
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- graded up to 72 h post dose. Animals killed at 7 d post dose and necropsy examination of skin performed.
- Number of animals:
- 6
- Details on study design:
- Hair was shaved on both sides of the spine using electric hair clippers, approximately 16 hours before application. The application site was ca. 2.5 cm x 2.5 cm = 6.25 cm2. Untreated skin was used as a negative control.
The left side was abraded over an area of ca. 6.25 cm2, with 5 vertical lines.
A tuberculin syringe was used for the application of 0.5 ml of unchanged test material. Following application to the skin the site was covered with 2 layers of gauze (2.5 cm x 2.5 cm in size). These were held onto the skin with elastic bandage. This was held in place with PVC film and adhesive tape. The exposure time was 24 hours.
Scoring of the test sites was performed according to the Draize method (see table below).
The test sites were scored at 24 and 72 h post dose. After 7 days post dose the animals were killed and a necropsy examination of the skin was performed for the assessment of the intact and abraded skin, subcutaneous tissues and musculature at the application sites.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 0.54
- Reversibility:
- other: necropsy examination performed at 7 days post dose.
- Remarks on result:
- other: necropsy examination of intact and abraded skin, subcutaneous tissue and underlying muscle were without findings for all animals.
- Irritant / corrosive response data:
- Overall mean was 0.54. Classified as not irritating.
- Other effects:
- A yellowish discolouration of the skin at the application sites was reported - this was possibly the test material.
Any other information on results incl. tables
Assessment levels and calculated irritation index – irritation grades
|
|
Rabbit number |
|
|
|||||
|
Time after application (h) |
1 |
2 |
3 |
4 |
5 |
6 |
Aggregate value |
Mean |
Erythema and Eschar formation Intact skin |
24
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 |
1 |
1 |
1 |
0 |
1 |
0 |
4 |
0.67 |
|
Erythema and Eschar formation Abraded skin |
24
|
0 |
0 |
1 |
1 |
0 |
1 |
3 |
0.5 |
72 |
1 |
1 |
1 |
1 |
1 |
1 |
6 |
1.0 |
|
Oedema formation Intact skin |
24
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema formation Abraded skin |
24
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Necropsy findings
Rabbit 1 |
intact and scarified skin: Subcutaneous tissue and underlying muscles without findings |
Rabbit 2 |
Findings as for rabbit 1 |
Rabbit 3 |
Findings as for rabbit 1 |
Rabbit 4 |
Findings as for rabbit 1 |
Rabbit 5 |
Findings as for rabbit 1 |
Rabbit 6 |
Findings as for rabbit 1 |
Applicant's summary and conclusion
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.
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