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EC number: 421-750-9 | CAS number: 57280-22-5 TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted prior to implementation of the new requirement to use as in vivo method the LLNA.
Test material
- Reference substance name:
- 4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane
- EC Number:
- 421-750-9
- EC Name:
- 4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane
- Cas Number:
- 57280-22-5
- Molecular formula:
- C7H12O3
- IUPAC Name:
- 4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hagemann
- Females (if applicable) nulliparous and non-pregnant: not specified
- Weight at study initiation: 391-528 g (males); 368-462 g (females)
- Housing: conventional; 1 or 2 animals per cage Makrolon®, type IV with embedding
- Diet (e.g. ad libitum): pell. Altromin® MS, hay and apple ad libitum
- Water (e.g. ad libitum): acidified, demineralized water (pH 2-3) ad libitum
- Acclimation period: 12 days
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 52-68
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- a) 0.1 ml FCA + vehicle (1 + 1)
b) 0.1 ml ZK 39294;. 5% (w/v)
c) 0.1 ml ZK 39294; 10% (w/v) + FCA (1 +·1) = 5% (w/v) - Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: A local tolerance study (pretest) was performed to ensure an intracutaneously tolerable concentration for the induction procedure which does not lead to necrosis (reddenings and swellings are allowed). The high concentration of 5% used in the present test for intracutaneous application is a recommended concentration for induction procedure, provided that the treatment does not produce excessive irritation. The reactions were recorded 24 hours after application. Furthermore, an epicutaneously tolerable concentration for the epicutaneous challenge was determined under occlusive conditiqns. Since no irritation after single epidermal application of the test item was observed in the local tolerance study on the skin of rabbits, the original substance was also tested epidermally for its local tolerance. Two concentrations, namely ca. 25%, and pure substance, were applied to the lateral backs.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 8 days and 48 h for intradermal and epicutaneous exposure, respectively.
- Test groups:
Intradermal:
A. Test group
a) 0.1 mL FCA + vehicle (1 + 1)
b) 0.1 mL ZK 39294;. 5% (w/v)
c) 0.1 mL ZK 39294; 10% (w/v) + FCA (1 +·1) = 5% (w/v)
epicutaneous:
The same area of skin (4 x 6 cm) in which intradermal injections were performed was reshaved on day 8 of the test and epidermally treated with approximately 1 mL sodium lauryl sulphate (10% (w/v)] in liquid paraffin. 24 hours later, on day 9, 0.2 mL of the original liquid compound was spread over a 2 x 4 cm filter paper {Whatmann, no. 3M) for use in the test group, whereas for the control group only 0.9% (w/v) NaCl-solution was used.
This filter paper was subsequently applied to the above-mentioned area pretreated with sodium lauryl sulphate. The patch was bandaged occlusively for 48 hours. The test item (pure) had previously been proved not to provoke any irritation on the skin atter epidermal administration under occlusion.
- Control group:
Intradermal:
B. Control group
a) 0.1 mL FCA + vehicle (1, + 1)
b) 0.1 mL vehicle
c) 0.1 mL FCA + vehicle (1 + 1)
Epicutaneous:
0.9% NaCl
- Site: In the neck region (right to left side of the spine) of each animal an overall area of 4 x 6 cm
- Frequency of applications: each once
- Duration: 8 days and 48h
- Concentrations: Intradermal 5%, Epicutaneously: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: on day 23
- Exposure period: 24 h
- Test groups: Approximately 0.1 mL ZK 39294 (original substance)., which previously proved to be well tolerated locally,. was spread over a 2 x 2 cm piece of filter paper. This patch was placed in the middle of the shorn area of skin and bandaged occlusively for 24 hours.
- Control group: 0.9% NaCl
- Site: a skin area of 5 x 5 cm on the right flank - Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- mercaptobenzothiazol
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: In the test more than 30% of the animals reacted positively to the challenge with mercaptobenzothiazoL
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.9% NaCl
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.9% NaCl
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 9
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The results of this study indicate that Trioxabicyclooctan has contact-sentitizing potential in the guinea-pig in the maximization test.
- Executive summary:
In a dermal sensitisation study according to OECD TG 406, (1992) with Trioxabicyclooctan (a.i. 100 %) in physiological saline (5%) solution for epicutaneous apllication, young adult Pribright guinea pigs were tested using the Maximization test method. Positive control substance was 2-mercaptobenzothiazole with a sensitisation rate of over 30 %.
Since the test substance was found not to cause a primary skin irritation in the dose range - finding study, the treated areas of the animals were irritated with sodium lauryl sulfate prior to the topical induction. After the challenge, 9 (90%) of the test substance animals responded with redness and swelling to the 100% test substance. There were no skin reactions in the control group. The controls exhibited no dermal reactions following the challenge with 100% test substance formulation. Therefore, the sensitisation rate was 0 %.
For the challenge concentration, which is the highest non-irritant dose, 100 % of the test item was used. In this study, Trioxabicyclooctan (a.i. 100 %), is a dermal sensitiser.
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