Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 November 1988 - 16 December 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1983
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
- EC Number:
- 402-990-3
- EC Name:
- A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
- Cas Number:
- 163702-01-0
- Molecular formula:
- C26H32O4
- IUPAC Name:
- Reaction mass of 2-hydroxy-1-{3-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one and 2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one
- Test material form:
- solid
- Remarks:
- Form specified in RSS.
Constituent 1
- Specific details on test material used for the study:
- The test article ARTICLE A, batch HE 230, was supplied by the Sponsor in the form of a orange-coloured vitreous solid.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- Crl:CD (SD) BR rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Charles River Company of Calco (Como), Italy
- Weight at study initiation:
102 to 130 g
- Assigned to test groups randomly:
The animaIs were allocated to the experimental groups, caged by five and appropriately identified. No formal randomization was adopted.
- Housing:
Rats were housed in a room expressly equipped for this test only, having the following ambient conditions: temperature 22 ± 2 deg. C, relative humidity 60% ± 20, 13 air changes per hour filtered on HEPA 98%, artificial lighting with a circadian cycle of 12 hours of light. Rats were kept for the entire duration of the study in makrolon cages (cm 42x26x15), each fitted with a stainless steel cover-feed rack. Dust-free poplar/fir chips (Type 700/2000 - Robino S.n.c. - Moncalieri -To), heat processed for resin removal, were used for bedding. The Producer supplies a certificate of analysis for each batch of wood chips. Contaminants that might interfere with the objective of the study were not expected to be present in bedding.
- Diet/water (e.g. ad libitum):
The animals were fed a diet coded 4RF21GLP, produced by Charles River Italia's feed licensee Italiana flangimi, Settimo flilanese. The declared contents, on the Iabel, on dry matter basis (moisture 12%), were
crude protein 21 %
crude fat 3.5 %
crude fibre 6.5 %
ash 9 %
Non-nitrogen extracts 60 %
The diet was supplemented by the Producer with vitamins and microelements. According to the analytical certificates provided by the supplier, the contents of the batch of diet used in this study were within ± 5% of the declared values and contaminants were within the limits proposed by EPA-TSCA 44FR:44053-44093, July 26, 1979).
The animal feed, in compliance with RBM SOPs Is analysed twice a year for bacterial contamination.
The diet was available to the animals "ad libitum".
Filtered water was distributed by means of an automatic watering valve system. The drinking water offered to the animals came from the municipal water main.
The water is periodically analysed for microbiological count, heavy metals and other physical and chemical properties. Contaminants that might interfere with the objectives of the study were not expected to be present either in the diet or in the water.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- On the basis of the Sponsor indication, due to the physical characteristics of the test article the material was freezed at -20 °C , then 8 grams were taken and ground by pestle and mortar and dissolved in olive-oil by gently warming to obtain the concentration of 200 mg/ml.
The formulate was prepared just before its use and kept protected from light (container wrapped with metal foil) .
Mitomycin C was dissolved in distilled water lo obtain the concentration of 0 .8 mg/ml. - Details on exposure:
- The negative controI and the test article were administered by oraI route (by gavage) , while Mitomycin C was administered by intraperitoneal route.
- Duration of treatment / exposure:
- 1 treatment
- Frequency of treatment:
- 1 treatment
- Post exposure period:
- 17 , 42 or 65 hours
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Negative controI (vehicle-lreated animals): 30 (15M + 15F)
Treated with ARTICLE A: 30 (15M + 15F)
Positive con traI (Mitomycin C): 10 (5M + 5F) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C; 8 mg/kg
Examinations
- Tissues and cell types examined:
- polychromatic erythrocytes
- Details of tissue and slide preparation:
- The femurs were immediately removed and the bone marrow taken, suspended, and accurately washed in 3 mI of fetal bovine serum.
The suspension was centrifuged at 1,000xg for 10'. The supernatant was carefully taken off and the celI sediment smeared on microscope slides.
Two slides/animal were prepared.
At least 20 hours later, the smears were stained as follows:
1. immersion in May Gruenwald (Merck) solution for 3 min.
2. immersion in May Gruenwald solution diluted 1: 1 with water for 2 min., then rinsed twice with water
3. immersion in Giemsa (Merck) solution diluted 1:6 with water for 10 min.
4. rinsing with water and accurate drying with filter paper
5. washing back surface and slide with methanol
The stained slides were coded and read at the microscope (1250 X). - Evaluation criteria:
- For each animaI, 2000 polychromatic erythrocytes were counted and scored for micronucleated cells.
- Statistics:
- Statistical evaluation: treated groups versus control group.
Data evaluation:
Comparison of the frequency among groups will be performed with a non-parametric method (Mann Whitney) (3).
Slgnificances were expressed in the following manner:
* p < 0.05
** p < 0.01
*** p < 0.001
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- On the basis of the resuIts and from the statistical analysis there is no significant difference between the micronucleus frequency in the treated group in comparison with the controi group, at any sampling time.
The group of animals treated with Mitomycin C showed a statistically different frequency of micronucleated cells in comparison with the control group.
Any other information on results incl. tables
Full data tables attached to background material section.
Applicant's summary and conclusion
- Conclusions:
- The results of this study indicate that the test article ARTICLE A, administered to Charles River rats by oral route at the dose of 2000 mg/kg, did not induce any statistically significant increase in the frequency of micronucleated cells in the bone marrow after 17, 42 and 65 hours from the administration.
- Executive summary:
The results of this study indicate that the test article administered to Charles River rats by oral route at the dose of 2000 mg/kg, did not induce any statistically significant increase in the frequency of micronucleated cells in the bone marrow after 17, 42 and 65 hours from the administration.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.