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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
Endpoint summary
Administrative data
Description of key information
Study conducted according to Annex to EEC directive 92/69/EWG, dated 31 Jul. 1992, for the 17th adaption of the EEC directive 67/548/EWG, 8.4. Acute Toxicity (Skin lrritation); young adult New Zealand White rabbits (4 animals) were dermally exposed to 500 µL of Trioxabicyclooctan (100 % a.i.) for 4 hours to 6.5 cm² skin, result: not classified
Study conducted according to OECD test guideline 405; 100 µL Trioxabicyclooctan (100 % a.i.) were instilled into the conjunctival sac of one eye of 3 young adult New Zealand White rabbits, observation period: 16 days, result: Category 2 (irritating to eyes)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-09-08 to 1996-01-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 31. July 1992
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Age at study initiation: adults
- Weight at study initiation: males: 2.7 - 2.8 kg; females: 2.6 - 2.8 kg
- Housing: individually in conventional metal cages
- Diet (e.g. ad libitum): pell. Altromin® K ad libitum
- Water (e.g. ad libitum): demineralized water ad libitum
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 64-70
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100% a.i.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² each site of the spine
- Type of wrap if used: Both sites (treated and untreated) were covered with a piece of gauze (semi-occlusive) fixed on the skin with Leukoflex®.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure the gauze was removed and the treated and untreated skin areas were wiped carefully with lukewarm tap water and cotton wool.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): Clinical observations were performed 30-60 minutes and 24 hours after end of exposure and thereafter daily until day 7 of the test and findings were recorded. Deviating from the method referred to in the study protocol the interval between daily clinical observations between days 4-5 for animal no. 548 and days 2-3 for the other animals was only 16 hours instead of 24 hours. This deviation is not considered to have influenced the result of the study since the animals were without findings on the respective days. Body weights were recorded on day 1 and day 7 of the test. Necropsy was not performed.
SCORING SYSTEM: According to guideline - Irritation parameter:
- edema score
- Basis:
- animal: #1 - #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 - #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test item provoked on the intact skin of the rabbit after single application only very slight to slight reddening in two males and one female animal only on the appl!ication day. No other findings were observed during the observation period of 7 days.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the system of evaluation recommended by EEC (1 ), the mean values of findings relevant for classification as ".irritant" (reddening· and scab formation, swelling) at the time points 24, 48 and 72 hours after application were 0. Also based to the classification criteria of Regulation (EU) No. 1272/2008 (CLP) the test item does not need to be classified with respect to skin irritation.
- Executive summary:
In a primary dermal irritation study according to Annex to EEC directive 92/69/EWG, dated 31 Jul. 1992, for the 17th adaption of the EEC directive 67/548/EWG, 8.4. Acute Toxicity (Skin lrritation), young adult New Zealand White rabbits (4 animals) were dermally exposed to 500 µL of Trioxabicyclooctan (100 % a.i.) for 4 hours to 6.5 cm² skin. Animals then were observed for 7 days. Irritation was scored by the method recommended by the guideline.
Trioxabicyclooctan provoked on the intact skin of the rabbit after single application only very slight to slight reddening in two males and one female animal only on the application day. No other findings were observed during the observation period of 7 days. According to the system of evaluation recommended by EEC (1 ), the mean values of findings relevant for classification as ".irritant" (reddening· and scab formation, swelling) at the time points 24, 48 and 72 hours after application were 0.
Based on the test results described above, the test item is not considered to be irritating to the skin according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March to June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 February 1987
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Age at study initiation: adults
- Weight at study initiation: male: 2.6 kg; females: 3.1 kg
- Housing: individually in conventional metal cages
- Diet (e.g. ad libitum): pell. Altromin® K; ad libitum
- Water (e.g. ad libitum): demineralized water; ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%):52-58
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100 % a.i.
- Duration of treatment / exposure:
- single exposure and observation 0.5, 1 and 2 h after application and once daily afterwards until day 16
- Observation period (in vivo):
- 16 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: According to OECD test guideline 405
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: not specified - Irritation parameter:
- chemosis score
- Basis:
- animal: #2 #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2 #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 16 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- On the whole, a single application of Trioxabicyclooctan into the conjunctival sac of the rabbit eye provoked severe irritation which lasted for several days after application and which only very slowly normalized over a period of up to 16 days.
Although the rabbit eye reacts more sensitively than the human eye due to anatomical and physiological. differences, similar effects have to be expected on the human eye. Therefore, inadvertent contact of the human eye with this substance should be strictly avoided. - Executive summary:
In a primary eye irritation study according to OECD test guideline 405 (1987), 100 µL Trioxabicyclooctan (100 % a.i.) were instilled into the conjunctival sac of one eye of 3 young adult New Zealand White rabbits. Animals then were observed for 16 days. Irritation was scored by the method recommended by the test guideline.
After application of 100 µL of the test sample into the conjunctival sac, there were slight reactions in the cornea and initially strong changes in the conjunctivae, which are completely reversible within 16 days. According to Regulation (EU) No. 1272/2008 (CLP) the test item is classified as Category 2 (irritating to eyes) based on the results obtained under the conditions described.
Reference
Test substance/ Calculation for EEC classification | ||||
Location (finding) | Time point after end of exposure time | 690M | 702F | 704F |
Cornea (opacity | 24 h | 1.0 | 1.0 | 1.0 |
48 h | 2.0 | 1.0 | 1.0 | |
72 h | 2.0 | 1.0 | 1.0 | |
Individual mean values |
| 1.67 | 1.0 | 1.0 |
| ||||
iris | 24 h | 1.0 | 1.0 | 1.0 |
48 h | 1.0 | 1.0 | 1.0 | |
72 h | 1.0 | 1.0 | 1.0 | |
Individual mean values |
| 1.0 | 1.0 | 1.0 |
| ||||
Conjunctivae (reddening) | 24 h | 2.0 | 3.0 | 3.0 |
48 h | 3.0 | 3.0 | 3.0 | |
72 h | 3.0 | 3.0 | 3.0 | |
Individual mean values |
| 2.67 | 3.0 | 3.0 |
| ||||
Conjunctivae (swelling) | 24 h | 2.0 | 3.0 | 3.0 |
48 h | 1.0 | 3.0 | 3.0 | |
72 h | 1.0 | 2.0 | 2.0 | |
Individual mean values |
| 1.3 | 2.67 | 2.67 |
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
In a primary dermal irritation study according to Annex to EEC directive 92/69/EWG, dated 31 Jul. 1992, for the 17th adaption of the EEC directive 67/548/EWG, 8.4. Acute Toxicity (Skin lrritation), young adult New Zealand White rabbits (4 animals) were dermally exposed to 500 µL of Trioxabicyclooctan (100 % a.i.) for 4 hours to 6.5 cm² skin. Animals then were observed for 7 days. Irritation was scored by the method recommended by the guideline.
Trioxabicyclooctan provoked on the intact skin of the rabbit after single application only very slight to slight reddening in two males and one female animal only on the application day. No other findings were observed during the observation period of 7 days. According to the system of evaluation recommended by EEC (1 ), the mean values of findings relevant for classification as ".irritant" (reddening· and scab formation, swelling) at the time points 24, 48 and 72 hours after application were 0.
Eye irritation/corrosion:
In a primary eye irritation study according to OECD test guideline 405 (1987), 100 µL Trioxabicyclooctan (100 % a.i.) were instilled into the conjunctival sac of one eye of 3 young adult New Zealand White rabbits. Animals then were observed for 16 days. Irritation was scored by the method recommended by the test guideline.
After application of 100 µL of the test sample into the conjunctival sac, there were slight reactions in the cornea and initially strong changes in the conjunctivae, which are completely reversible within 16 days.
Justification for classification or non-classification
Based on the test results described above, the test item is not considered to be irritating to the skin according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
According to Regulation (EU) No. 1272/2008 (CLP) the test item is classified as Category 2 (irritating to eyes) based on the results obtained under the conditions described.
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