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EC number: 402-990-3 | CAS number: 163702-01-0 ESACURE KIP 100; ESACURE KIP 150
- 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
Endpoint summary
Administrative data
Description of key information
Study conducted to recognised testing guidelines with GLP certification.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Organisation for Economic Co-operation and Development (1981) OECD Short-term and Long-term Toxicology Groups. Final Report; Acute oral Toxicity -
12 May, p. 401 - Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Acclimation period:
One week
Source: Nossan Correzzana Breeding Centre
Average weight: 200 ± 20g
Quarantine period: 1 week
Diet: Pellets supplied by Nossan, Correzzana, Milan.
Environmental conditions:
Atmospheric pressure
Temperature: 20 ± 2 °C
Humidity: 55 ± 10% relative humidity
Air changes: At least 8 per hour
Light/Dark cycles: 12 hours
Cages:
In transparent polycarbonate model 1290 (dimensions 425 X 260 X h 150 mm) of the company "Tecniplast" Gazzada (Va)
Water:
Ad libitum. Municipal aqueduct water filtered with Seitz filter, chemically and bacteriologically analyzed twice a year. - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- The animals were fasted for the night before treatment, then weighed and the substance administered in a single dose. After this dose, the animals were fasted.
- Doses:
- 5000 mg/kg bw/day
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- Observation period: 14 days
Clinical examination - Pathology: Once a day
Signs of toxicity: Weight changes, diarrhea, general condition of the rats and any deviations from the norm.
Rats that survive the observation period are weighed and those weights are then compared to the control animals. Rats that died during this period underwent an autopsy which also examined their organs. Similarly, the rats that survive the observation period were sacrfieced and examined for the prescence of toxicological activity that had not revealed itself through the observation period. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Mortality:
- No death was observed in any of the animals treated with 11 samples after one 14-day observation period.
- Clinical signs:
- other: No alterations attributable to the test substance were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results obtained, we can state that the test substance (EC 402-990-3) given to healthy rats does not cause signs of toxicity due to doses lower than 5000 mg/kg.
- Executive summary:
In this guideline study (equivalent to OECD 401), the test substance EC 402-990-3 was shown to have an LD50 of ≥5000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- 1
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- 1
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: None
- Gross pathology:
- Effects on organs: No abnormability was noted during the necroscopy of all the animals
- Other findings:
- Signs of toxicity (local): None
No mortality during the observation period (15 days) - Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- 1
Additional information
Oral LD50 >= 5000 mg/kg bw
Dermal LD50 >2000 mg/kg bw
Justification for classification or non-classification
The substance does not meet the criteria for classification in accordance with the classification, labelling and packaging regulation (EC 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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