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EC number: 442-600-9 | CAS number: -
- 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:
- 03-06-2001-19-06-2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according with OECD guideline 420.
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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Includes statement of compliance
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 442-600-9
- EC Name:
- -
- Molecular formula:
- The substance is a UVCB for which it is not possible to provide a molecular formula
- IUPAC Name:
- (9E)-N-[(N'-hexadecanoyloctadecanehydrazido)methanimidoyl]octadec-9-enamide
- Details on test material:
- Name: HiTEC 7134
Source: Afton Chemicals
Colour: Brown
Physical state: Viscous liquid
Storage conditions: Ambient temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk: APfSD (Wistar derived)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rodent Breeding Unit, Alderley Prk, Macclesfield, Cheshire, UK
- Age at study initiation: app. 8-12 weeks old
- Weight at study initiation: 381-413 g (males) and 241-266 g (females)
- Fasting period before study: yes
- Housing: maximum of 5 rats were housed per each cage, sexes separately, in cages suitable for animals of this strain and the weight range expected during the course of the study.
- Diet: ad libitum
- Water : ad libitum
- Acclimation period: animals were housed under the experimental conditions at least 5 days prior the initiation of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3º C
- Humidity (%): 30-70 %
- Air changes (per hr): a minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): artificial, giving 12 hours light, 12 hours dark
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: the substance is miscible and stable in corn oil
- Lot/batch no. (if required): Y00790/007
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
DOSAGE PREPARATION: a measured amount of the test substance was formulated in corn oiland was then warmed and stirred thoroughly to ensure homogeneity. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females and 5 males per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, careful examinations of all thoracic and abdominal viscera - Statistics:
- NA
Results and discussion
- Preliminary study:
- Following a dose of 500 mg/kg, the animal survived and showed no signs of systemic toxicity. Following a dose of 2000 mg/kg, the animal survived and showed signs of slight, but not evident toxicity, with comlete recovery by day 3.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died.
- Clinical signs:
- other: No evident toxicity signs observed. Only one female presented signed of slight toxicity on days 3 to 5.
- Gross pathology:
- There were no compound-related abnormalities at post mortem examination. One male as a speckled thymus which is considered to be a spontaneous finding. One female killed in extremis on day 2 had oesophageal damage, lung abnormalities and fluid in the thorax, all of which were considered mis-dosing.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The highest fixed dose of HiTEC 7134 administered in this test without causing any lethality (i.e.) the discriminating dose-level), was 2000 mg/kg to male and female rats.
- Executive summary:
In a sighting phase, single animals received a single oral dose of 500 or 2000 mg/kg of HiTEC 7134 and were assessed daily for the following 6 days for signs of toxicity.
From the results of the sighting phase a single fixed dose level of 2000 mg/kg was selected for the main phase of the study.
In the main phase, a group of five male and five female Alpk: APfSD (Wistar derived) rats was dosed and assessed daily for the following 14 days for any signs of systemic toxicity. Their body weights were recorded at intervals during the study. At the end of the study all the animals were killed and examined post mortem.
No animals died in the sighting phase or in the main study. There were no signs of evident toxicity, and most of the animals showed an overral weight gain during the study. There were no compound related abnormalities at examination post mortem.
The highest fixed dose of HiTEC 7134 administered in this test without causing any lethality (i.e. the discriminating dose-level), was 2000 mg/kg to male and female rats.
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