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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 18, 2001 till August 14, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 402 (Acute Dermal Toxicity) 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 440-930-8
- EC Name:
- -
- Cas Number:
- 330198-48-6
- Molecular formula:
- C19H28N2O3 / C21H32N2O3 / C23H36N2O3 / C29H50N2O4 / C31H54N2O4 / C33H58N2O4 / C35H62N2O4 / C37H66N2O4
- IUPAC Name:
- Condensation products of 4-methyl-m-phenylene diisocyanate with alcohols, C10-14 (even numbered)
- Details on test material:
- Identity: ZP-TIX 1014
Batch number: NW-01-028
Appearance: solid
Purity: >99%
Stable under storage conditions, i.e. at room temperature (17-23°C), away from direct sunlight
Expiry date: 30.12.2001
The test item consists of three components, which appear as three separate peaks in the HPLC chromatogramm.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on animals: Rat, HanBrl: WIST (SPF)
Source of rats: RCC Ltd (Füllingsdorf, Switzerland)
Sex: both
Number of animals per group: 5 male and 5 female
Age (when treated): male (10 weeks) female (13 weeks)
Acclimatization: Under laboratory conditions after health examination. Only healthy animals without visual signs of illness were used.
Conditions: Standard Laboratory Conditions
- Air-conditioned with 10-15 air changes per hour
- continously monitored environment with target ranges for temperature 22±3°C and for relative humidity between 30-70%
- 12 hours fluorescent light/12 hours dark (light period 6:00 and 18:00h)
- music during light period
Accommodation: In groups of five per sex in Makrolon type-4 cages with standardised softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland)
Diet: Pelleted standard Provimi Kliba 3433 (batch no. 72/01) rat maintenance diet available ad libitum.
Water: Community tap water from Itingen, Switzerland, available ad libitum.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- TEST SITE
Area of exposure: approximately 10% of the total body surface
Dressing: semi-occlusive dressing
Type of wrap if used: wrapped around the abdomen and fixed with an elastic adhesive bandage, no further data
REMOVAL OF TEST SUBSTANCE
Washing (if done): skin was flushed with lukewarm tap water
Time after start of exposure: 24h
TEST MATERIAL
Amount(s) applied (volume or weight with unit): 2000mg/kg b.w. in PEG 300
Concentration (if solution): 0.5 g/mL
Constant volume or concentration used: 4mL
VEHICLE
Identity: polyethylene glycol PEG 300
Lot/batch no. (if required): 412565/151301
Purity: no data
OTHER DETAILS:
One day before exposure the back of the animals were clipped exposing an area of approximately 10% of the total body surface. Only animal without injury or irritation on skin were used. The preparation of the test item was made shortly before dermal application. On test day 1 the test item was applied at a dose of 2000mg/kg b.w. and covered with a semi-occlusive dressing.The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. - Duration of exposure:
- 24h
- Doses:
- 2000mg/kg b.w.
- No. of animals per sex per dose:
- 5 male and 5 female animal per dose
- Control animals:
- no
- Details on study design:
- Observation periode: 14 days
Frequency of observations and weighing:
- mortality: daily during acclimatization and at least one, two, three and approximatley five hours after test item administraion.
- body weights: pre administration (day 1), day 8 and 15
- clinical signs: daily during acclimatization and at least one, two, three and approximatley five hours after test item administraion (test day 1)
Necropsy of survivors performed: yes
Other examinations performed: all animals were examined macroscopically at necropsy and thereafter discarded
Test item preparation: Testitem was placed into a glass baker and the vehicle (PEG 300) was added and warmed up to approx. 50°C for 2 minutes.
A weight by volumen dilution was prepared. Homogeneity of the test item in the vehicle was maintained during treatment. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occured during the study.
- Clinical signs:
- other: Scales and slight or moderate erythema maculate was noted in males at 2000mg/kg on test day 4 until test day 14. Scales and slight or moderate erythema maculate and in one case general erythema was note in the females at 2000mg/kg bw on test day 6 until t
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of ZP-TIX 1014 after single dermal adminsitration to rats of both sexes observed over a period of 14 days was
LD50(rat) > 2000mg/kg bodyweight - Executive summary:
OECD Guideline 402 (Acute Dermal Toxicity) a group of five male and five female HanBrl: Wist (SPF) rats was treated with ZP_TIX 1014 at 2000 mg/kg bw by dermal application. The test item was diluted in polyethylen glycol (PEG 300) and a volumen of 4 mL (weight corrected concentration approximately 0.5g/mL) was dermal administered. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2 -15. Mortality/viability was recorded together with clinical signs in the same time intervals. Body weights were recorded an day 1 (prior administraion) and day 8 and 15. All animals were necropsied and examined macroscopically at the end of the study.
No deaths occured during the study.
Scales and slight or moderate erythema maculate was noted in males at 2000mg/kg on test day 4 until test day 14. Scales and slight or moderate erythema maculate and in one case general erythema was note in the females at 2000mg/kg bw on test day 6 until test day 15.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were observed at necropsy.
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