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EC number: 440-930-8 | CAS number: 330198-48-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 14, 2001 till August 23, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline 404 (Acute Dermal Irritation/Corrosion) under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ZP-TIX 1014
- IUPAC Name:
- ZP-TIX 1014
- Details on test material:
- Identity: ZP-TIX 1014
Purity > 99%
Batch number: NW-01-028
Expiry date: 30.12.2001
Description: solid
Stability of test item: Stable under storage conditions
Storage conditions: in the original container, at room temperature ( range of 17-23°C), away from direct sunlight
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source of rabbits: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalarone (France)
Number of animals per test: 3 (Animals of both sexes were used)
Age: 11-12 weeks (male), 10-12 weeks (female)
Acclimatization: Under laboratory conditions after health examination. Only healthy animals (judged by visual signs) were used.
Conditions: Standard Laboratory Conditions
Accomodation: Individually in stainless stell cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (bact no. 91/01) and haysticks (QS no. 74/01) provided by Eberle Nafag AG, CH-9200 Gossau.
Water: Community tap water from Füllingsdorf, Switzerland.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with electric clipper
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5mg/animal, moistened with approximately 0.1 ml bi-distilled water before application
- Duration of treatment / exposure:
- The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean th application site so that any reactions (erythema) were clearly visible at that time.
- Observation period:
- 72 h
- Number of animals:
- 3 per test
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: max. score was reached after one hour and not present anymore at 24hours
- Other effects:
- No other effects.
The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Animal Number | Sex | Evaluation Interval | Erythema | Oedema |
42 | M | 1 hour | 1 | 0 |
43 | F | 1 | 0 | |
44 | F | 1 | 0 | |
42 | M | 24 hours | 0 | 0 |
43 | F | 0 | 0 | |
44 | F | 0 | 0 | |
42 | M | 48 hours | 0 | 0 |
43 | F | 0 | 0 | |
44 | F | 0 | 0 | |
42 | M | 72 hours | 0 | 0 |
43 | F | 0 | 0 | |
44 | F | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the reffered classification criteria (EEC Commission Directive 93/21/EEC of April 27,1993), ZP-TIX 1014 is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of ZP-TIX 1014 was investigated by topical semiconclusive application of 0.5g to 6cm² intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
Very slight erythema was observed at the test site of all animals 1 hour after treatment.
The test item did not however elicit any skin reactions at the application site of any animal at the 24 -, 48- or 72 hour readings. The mean values from 24 to 72 hours were therefore 0 for erythema an 0 for oedema.
The test item caused no staining of the treated skin.
No corrosive effects were noted on the treated skin of any animal at any measuring interval.
Based upon the referred classification criteria (EEC Commission Directive 93/21/ EEC of April 27,1993, ZP-TIX 1014 is considered to be "not irritating" to rabbit skin.
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