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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 19, 2001 till September 4, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method) 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- Physical state: solid
Batch number: NW-01-028
Purity: >99%
Stable under storage conditions, i.e. in original container at room temperature (17-23°C), not in direct sunlight.
Expiry date: 30 Dec 2001
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
Age: 8-10 weeks
Acclimatization: Under laboratory conditions after health examination. Only healthy animals (judged by visual signs) 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 flurescent light/12 hours dark (light period 6:00 and 18:00h)
- music during light period
Accommodation: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardised siftwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland)
Diet: Pelleted standard Provimi Kliba 3433 rat maintenance diet ad libitum (batch no. 72/01 and no. 73/01).
Water: Community tap water from Itingen, Switzerland, ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- The rats received a single oral dose of the test substance by gavage at 2000mg/kg or 200mg/kg after being fastened for 16-20 hours (access to water was permitted). Food was provided again approx. 3 hours after dosing. The application volume was 10ml/kg body weight.
- Doses:
- 2000mg/kg and 200mg/kg
The preparations were made shortly before dosing.
The test substance was weighted into a tared glass beaker on a suitable precision balance and the vehicle (PEG 300, Fluka Chemie AG (Buchs, Switzerland), batch no. 412565/1 50501 (at 2000mg/kg) and 412565/1 51301 (at 200mg/kg)) added (weight:volume) and warmed up to approx. 50°C for approx. 2 minutes. The mixtures were prepared using a magnetic stirrer. Homogeneitty of the test substance in the vehicle was maintained during administration using a magnetic stirrer. - No. of animals per sex per dose:
- 2000 mg/kg: 3 male and 3 female
200 mg/kg: 3 male - Control animals:
- no
- Details on study design:
- Study duration: 14 days
Frequency of observations and weighing:
- Body weight: on test days 1 (pre admin.), 8 and 15
- Clinical signs: daily during acclimatisation, four times on test day 1 (after admin.), once daily during day 2-15
- Mortality / Viability: Daily during acclimatization, twice daily during days 1-15
Necropsy of survivors performed: yes
Other examinations performed: All animal were discarded after necropsy and macroscopic examination. No organs or tissues were retained - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Mortality:
- 2000 mg/kg: All three males, i.e. 100%, were found dead on test day 2 or 3. All females survived until the end of the observation period.
200 mg/kg: All three males survived until the end of the observation period. - Clinical signs:
- other: Fluffled fur, lateral recumbency, sedation and dyspnea were noted in all males at 2000 mg/kg before they were found dead. Ruffled fur was noted in the females at 2000mg/kg on test day 1 and from test day 6 to 14. Hunched posture and slight or moderate ema
- Gross pathology:
- In all males at 2000mg/kg, which were found dead, dark red discoloration of the lungs was noted. No macroscopic findings were observed in all survving animals at necrospy.
Any other information on results incl. tables
Body weights
dose (mg/kg) | animal ident. | sex | Day 1 (treatment) | Day 8 | Day 15 |
2000 | 1 | f | 173.3 | 152.8 | 196.7 |
2000 | 2 | f | 172.0 | 154.0 | 187.7 |
2000 | 3 | f | 173.0 | 170.5 | 204.9 |
2000 | 4 | m | 199.3 | - | - |
2000 | 5 | m | 198.7 | - | - |
2000 | 6 | m | 196.7 | - | - |
200 | 7 | m | 199.7 | 239.5 | 251.9 |
200 | 8 | m | 200.9 | 243.5 | 265.3 |
200 | 9 | m | 202.2 | 249.5 | 278.1 |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of ZP-TIX 1014 after single oral administration to rats of both sexes (acc. to OECD guideline 423), observed over a period of 14 days was:
LD50 (female rat): > 2000mg/kg body weight
LD50 (male rat): > 200mg/kg body weight, but < 2000mg/kg body weight - Executive summary:
One group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with ZP-TIX 1014 at 2000 mg/kg body weight. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a volume of 10 mL/kg.
One group of three male HanBrl: WIST (SPF) rats were treated by oral gavage with ZP-TIX 1014 at 200 mg/kg body weight. The test item was suspended in vehicle (PEG 300) at a concentration of 0.02 g/ml and administered at a volume of 10 mL/kg.
The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15.All animals were necropsied and examined macroscopically.
The following animals were treated and percentage of mortality was observed:
males females
2000 mg/kg bw 100% 0%
200 mg/kg bw 0%
The males at 2000 mg/kg were found dead on test days 2 or 3. All other animals survived until the end of the observation period.
Ruffled fur, lateral recumbency, sedation and dyspnea were noted in all males at 2000 mg/kg before they were found dead. Ruffled fur was noted in the females at 2000 mg/kg on test day one and from test day 6 until 14. Hunched posture and slight or moderate emaciation was evident in two females at 2000 mg/kg from test day 6 until test day 12. The males at 200 mg/kg were without clinical signs.
Females at 2000 mg/kg lost weight from the first test day until test day 8, after this period they gained weight. The body weight of the males at 200 mg/kg was within the range commonly recorded for this strain and age.
In all males at 2000 mg/kg wh ich were found dead, dark red discoloration of the lungs was noted. No macroscopic findings were observed in all surviving animals at necropsy.
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