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EC number: 455-560-2 | 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
Endpoint summary
Administrative data
Description of key information
Based on these results, pentamethyl-trioxepane would not be regarded as skin sensitizer, does not have to be classified for sensitisation by skin contact and has no obligatory labeling requirement for sensitisation by skin contact.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- See Principles of method if other than Guideline. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
- Principles of method if other than guideline:
- 1. Temporary deviations from the minimum level of relative humidity occurred. Evaluation: Laboratory historical data do not indicate an effect of the deviations.
2. For animal nos. 21-25, the concurrent vehicle control group from project 439425 was used instead from project 439414. Evaluation: Project 439414 did not contain a vehicle control group. The control animals of Notox Project 439425 were treated within the same time frame as this study, using the same procedures and the same batch of vehicle, animals and 3H-methyl thymidine. - GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Remarks:
- inbred, SPF-Quality
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Charles River France, L'Arbresle Cedex, France
25 femals (five groups of five females each group) (nulliparous and non-pregnant).
Young adult animals (approx. 11 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean.
Identification: Tail mark with marker pen.
Conditions:
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +/- 3.0 oC (actual range: 18.6-22.7 oC), a relative humidity of 30-70% (actual range 23-83%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
Accomodation:
Individual housing in labeled Macrolon cages (MI type: height 12.5 cm) containing sterilized sawdust as bedding material (Woody-Clean type 3/4: Tecnilab-BMIBV, Someren, The Netherlands).
Acclimatization period:
The acclimatization period was at least 5 days before the start of treatment under laboratory conditions. Accomodation was as described above except that the animlas were group housed in Macrolon cages (MIII type: height 15 cm). Paper (Enviro-dri, BMI, Helmond, The Netherlands) was supplied as cage-enrichment.
Diet:
Free access to standard pelletized laboratory animal diet (code VRF 1, Altromin, Lage, Germany).
Water:
Free access to tap water. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- The vehicle was selected based on trial formulations performed at Notox and on test substance data supplied by the sponsor.
- Concentration:
- 10, 50 and 100 %
- No. of animals per dose:
- Five groups of five females each group
- Details on study design:
- Preliminary irritation study:
A preliminary irritation study was conducted in order to select the highest test substance concentration to be used in the main study. In principle, this concentration should be well tolerated systemically by the animals and may give moderate irritation (grade 2) at the highest.
Main study:
Initially, three groups of five animals were treated with one test substance concentration each group (10 %, 50 % and 100 % test substance, respectively). One group of five animals was treated with vehicle. Based on the results, one additional group was treated with the undiluted test substasnce.
Induction - Days 1, 2 and 3:
Experimental animals:
The dorsal surface of both ears was epidermally treated (25 ml/ear) with the test substance concentration, at approximately the same time each day.
Vehicle control animals:
The control animals were treated the same as the experimental animals, except that, instead of the test substance, the vehicle alone was administered.
Treatment - Day 6:
All animals:
Each animal was injected via the tail vein with 0.25 ml of sterile phosphate buffered saline (PBS) (Merck, Darmstadt, Germany) containing 20 uCi of 3H-methyl thymidine (Amersham Biosciences, Buckinghamshire, UK).
After approximately five hours, all animals were killed by intra peritoneal injection wtih pentobarbital (0.2 ml/animal Euthesate; Sanofi Sante B.V., Maassluis, The Netherlands). The draining (auricular) lymph node of each ear was excised. The relative size of the nodes (as compared to normal) was estimated by visual examination and abnormalities of the nodes and surrounding area were recorded. The nodes were pooled for each animal in approximately 3 ml PBS.
Tissue processing for radioactivity - Day 6:
A single cell suspension of lymph node cells (LNC) was prepared in PBS by gentle separation through stainless steel gauze (diameter 125 um). LNC were washed twice with an excess of PBS by centrifugation at 200g for 10 minutes at 4o C. The DNA was precipitated with 3 ml 5% trichloroacetic acid (TCA) (Merck, Darmstadt, Germany) at 4 oC. Precipitates were recovered by centrifugation, resuspended in 1 ml TCA and transferred to 10 ml of Ulitma Gold cocktail (Packard Bioscience B.V., Groningen, The Netherlands) as the scintillation fluid.
Radioactivity measurements - Day 7:
All radioactive measurements were performed using a Packard scintillation counter (1900TR). Counting time was to a statistical precision of +/- 0.2% or a maximum of 5 minutes whichever comes first. The Packard 1900TR was programmed to automatically subtract background and convert Counts Per Minute (CPM) to Disintegrations Per Minute (DPM). - Key result
- Parameter:
- SI
- Value:
- 2.7
- Variability:
- 1.3 @ 10 %, 2.4 @ 50 % and 2.7 @ 100 %
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Remarks:
- DEREK insilico SAR results
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these results, it was concluded that there was no indication that the test substance could elicit an SI >= 3 when tested up to 100 %. This result was corroborated by the outcome of the unvalidated DEREK insilico SAR results, that showed the absence of structural alerts indicative for skin sensitisation.
Based on these results, pentamethyl-trioxepane would not be regarded as skin sensitizer, does not have to be classified for sensitisation by skin contact and has no obligatory labeling requirement for sensitisation by skin contact. - Executive summary:
Based on these results, pentamethyl-trioxepane would not be regarded as skin sensitizer, does not have to be classified for sensitisation by skin contact and has no obligatory labeling requirement for sensitisation by skin contact.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on these results, it was concluded that there was no indication that the test substance could elicit an SI >= 3 when tested up to 100 %. This result was corroborated by the outcome of the unvalidated DEREK insilico SAR results, that showed the absence of structural alerts indicative for skin sensitisation.
Based on these results, pentamethyl-trioxepane would not be regarded as skin sensitizer, does not have to be classified for sensitisation by skin contact and has no obligatory labeling requirement for sensitisation by skin contact. Data are complete but not sufficient for classification.
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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