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EC number: 436-900-9 | CAS number: 39290-90-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 October 2000 - 03 November 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study has been performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 436-900-9
- EC Name:
- -
- Cas Number:
- 39290-90-9
- Molecular formula:
- Hill Empirical formula: K(0.2-0.7) Mg(0.4) Ti(1.6) O(3.7-3.95) CAS Empirical formula: K(0.2-0.7) Mg(0.4) Ti(1.6) O(3.7-3.95)
- IUPAC Name:
- Magnesium Potassium Titanium Oxide
- Details on test material:
- Batch: 0G99
White powder
Expiry date: 21 August 2001
Test substance storage: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Animal: Albino rabbit, New Zealand white (SPF quality). Earmark.
- Source: Charles River Deutschland, Kissleg, Germany
- Age at study initiation: at least 8 weeks old
- Body weight at study initiation: between 1.0 and 3.5 kg
- Housing: individually housed in labelled cages with perforated floors (Scanbur, Denmark, 53.3x63x38.5 cm) and equipped with an automatic drinking system.
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approximately 100 grams per day. In addition hay (BMI, Helmond, The Netherlands) was provided twice a week.
- Water: Free access to tap water.
- The acclimation period was at least 5 days before the start of treatment under laboratory conditions.
A health inspection was performed prior to treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.
All certificates of analysis (diet and water) are retained in the NOTOX archives.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3CºC
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 15 air changes per hour- Photoperiod (hrs dark / hrs light): 12 hours artificial
fluorescent light and 12 hours darkness per day.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with electric clippers
- Vehicle:
- water
- Remarks:
- Milli-U water
- Controls:
- other: Adjacent areas of the untreated skin of each animal
- Amount / concentration applied:
- 500 mg. The powdery test substance was moistened with Milli-U water, immediately before application, to ensure close contact with the animal's skin.
- Duration of treatment / exposure:
- 4 h of exposure-single application
- Observation period:
- The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE/OBSERVATIONS:
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm²). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.
Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was applied to the skin of one flank, using a metalline patch# of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water.
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.
The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
Observations for mortality/viability: twice daily. Obervations for toxicity: at least once daily. Body weight: measured prior to application.
SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
Erythema and eschar formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) *
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) was given.
Oedema formation:
0: No oedema
1; Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (raised approximately 1 millimeter)
4: Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: average score over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Highest score (1) after 1 h
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: average score over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: All individual scores: 0
- Irritant / corrosive response data:
- Very slight erythema in the treated skin-areas of all three rabbits. The skin irritation had resolved within 24 hours after exposure.
- Other effects:
- No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Terracess P is not irritating to skin (4 h exposure to rabbit skin under semi-occlusive conditions).
Terracess P does not have to be classified and has no obligatory labelling requirement for skin irritation.
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