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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 919-979-9 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 12/07/2010 to 21/07/2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ozonized Tetramers and Pentamers
- IUPAC Name:
- Ozonized Tetramers and Pentamers
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- Free Ozonized Acids
- IUPAC Name:
- Free Ozonized Acids
- Reference substance name:
- Ozonized Trimers
- IUPAC Name:
- Ozonized Trimers
- Reference substance name:
- Ozonized Dimers
- IUPAC Name:
- Ozonized Dimers
- Reference substance name:
- Ozonized Triglycerides
- IUPAC Name:
- Ozonized Triglycerides
- Test material form:
- other: oiy gel
Constituent 1
impurity 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles Rivera - Italy
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: eight-weeks old
- Weight at study initiation: from 8.7 to 9.4g
- Housing: Mice were housed in Standard Pathogen Free (SPF) conditions in a microbiologically controlled animal facility.
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Photoperiod (hrs dark / hrs light): 12 hours continuous artificial light within each 24-hrs period
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- The sample is an oil and was used not diluted (100%) and at 50% and 25% dilutions in acetone/olive oil (AOO, 4/1 vol/vol).
- Concentration:
- 100% (not diluted) - 50% - 25%
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility:
- Substance Toxicity: the test substance was not expected any severe toxicity or irritancy
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Results for each treatment groups are expressed as the mean Stimulation Index (SI). The SI is the ratio of the mean dpm/mouse within each test product treatment group and the positive control treated group against the mean dpm/mouse for the solvent/vehicle treated control group. In general, when the SI is 3 or more, the test substance is regarded as a skin sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION:
Test product and controls were applied daily for three days (25 μl per each ear pinnae) with a micropipette. Five days following the initiation of exposure all mice receive an intravenous injection of 3H-labeled thymidine and five hours later animals are sacrificed and draining (auricular) lymph nodes are excised and pooled for each experimental group. A single cell suspension of lymph nodes is prepared by gentle mechanical disaggregation and the cells washed and resuspended in trichloroacetic acid (TCA) for at least 12h at 4°C. Precipitates are resuspended in TCA and transferred to an appropriate scintillation fluid. The incorporation by draining lymph nodes of 3H-labeled thymidine is measured by scintillation counting and recorded as mean disintegrations per minute (dpm) for each experimental group. For each concentration of the test material a Stimulation Index (SI) is derived relative to the concurrent vehicle control. - Positive control substance(s):
- other: 1-Fluoro-2,4-dinitrobenzene (CAS 70-34-8) 0,02%. This concentration was chosen on the basis of the EC50 value of this substance, i.e. the concentration capable to elicit a 3x increase in 3H-thymidine incorporation in this test, without overt toxicity.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- 100% Substace
- Value:
- 0.99
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Parameter:
- SI
- Remarks:
- 50% dilutions in acetone/olive oil (AOO, 4/1 vol/vol)
- Value:
- 1.07
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Parameter:
- SI
- Remarks:
- 25% dilutions in acetone/olive oil (AOO, 4/1 vol/vol)
- Value:
- 0.95
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the above experimental conditions, the sample did not show any skin sensitizing potential.
- Executive summary:
Eight-weeks old, CBA/j, female mice from Charles River Italia were used. Mice were divided into 3 groups of 4 animal each. Four mice per group were tested. Mice were housed in Standard Pathogen Free (SPF) conditions in a microbiologically controlled animal facility. Husbandry was at 20°C with 12 hours continuous artificial light within each 24-hrs period. Mice were housed at a density of 4 mice per cage since arrival to the animal facility. They were housed 7 days for acclimatization before testing.
The Animal House Facility is a barrier facility and procedures include provision of sterilized bedding, autoclaved feed, and filtered drinking water. Standard laboratory rodent diet is used (see enclosure A). All caging equipment is washed in barrier processing facilities and autoclaved. All animals are housed in filter top cages (static microisolators). Individually ventilated cages and static microisolator cages are changed every week. Mice are transferred to clean cages using disinfected forceps. The cage, food, and bedding are autoclaved and the water is filtered (autoclaved only for immunodepressed mice). Procedures for barrier facilities include sanitation or sterilization of all supplies and equipment. Personnel working in barrier facilities wear sterilized clothing including bodysuit with hood, shoe covers, caps, masks, double gloves and passage via air shower prior to entry.
Sentinels are exposed to dirty bedding from cages in their respective rooms. Sentinels are euthanized for serology, bacteriology, parassitoloy, and pathology screening every three months and/or annually as specified in the report.
Mice of each group were weighted at time zero (T0) and after the 5-days time (T5d) of the protocol. Weights of individuals animals and mean values were ranging from 8.7 to 9.4g at T0 to 9.0 to 10.0g at T5d.
Test product and controls were applied daily for three days (25 μl per each ear pinnae) with a micropipette. Five days following the initiation of exposure all mice receive an intravenous injection of 3H-labeled thymidine and five hours later animals are sacrificed and draining (auricular) lymph nodes are excised and pooled for each experimental group. A single cell suspension of lymph nodes is prepared by gentle mechanical disaggregation and the cells washed and resuspended in trichloroacetic acid (TCA) for at least 12h at 4°C. Precipitates are resuspended in TCA and transferred to an appropriate scintillation fluid. The incorporation by draining lymph nodes of 3H-labeled thymidine is measured by scintillation counting and recorded as mean disintegrations per minute (dpm) for each experimental group. For each concentration of the test material a Stimulation Index (SI) is derived relative to the concurrent vehicle control.
No signs of general toxicity were observed. No animals had any weight loss. Locally, no signs of irritation were observed in any animal, including the DNFB treated mice. This last observation is likely due to the relatively low concentration (0,02%) of DNFB we used. DNFB showed an evident sensitising effect, as expected.
In the above experimental conditions, the sample did not show any skin sensitizing potential.
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.