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EC number: 225-533-8 | CAS number: 4904-61-4
- 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
Skin
1983: According to OECD 404; pre-GLP; 6 rabbits; undiluted test substance; slightly irritating (K1)
Eye
1983: According to OECD 405; pre-GLP; 6 Small White Russian rabbits; undiluted test substance; no irritant effects (K1)
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:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.2 - 2.7 kg
- Number of animals: 3 males, 3 females
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
- Water: tap water ad libitum
Environmental conditions:
- Room temperature: 20°C (+/- 1°C);
- Humidity: 60% (+/- 5%);
- Air change: 15 times/hour;
- Light: 12 hour light/dark rhythm;
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1, 24, 48, 72 hours; 6, 8, 11, 14 days after exposure
- Number of animals:
- 6
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: ca. 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Postexposure period: 14 days
- Removal of test substance: dist. water
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet
- Examination time points: 1, 24, 48, 72 hours; 6, 8, 11, 14 days; evaluation based on readings 1-4 - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 8
- Remarks on result:
- other: additional time point after 1 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.00
- Edema: 0.61 - Other effects:
- no other effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test item 1,5,9 -cyclododecatrien showed a slightly irritant effect on the skin of male and female rabbits which leads to no classification according to 67/548/EEC and according CLP regulation (1272/2008).
- Executive summary:
To test the acute skin irritant effect the test item 1,5,9 -cyclododecatrien was applied to the shaven dorsal skin of 3 male and 3 female rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours. According to the study, the test item 1,5,9 -cyclododecatrien showed a slightly irritant effect on the skin of male and female rabbits
.
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:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Sex: male/female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.3 - 2.5 kg
- Number of animals: 3 per sex
- Controls: untreated eye
- Number of animals: 3 males, 3 females
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
- Water: tap water ad libitum
Environmental conditions:
- Room temperature: 20°C (+/- 1°C);
- Humidity: 60% (+/- 5%);
- Air change: 15 times/hour;
- Light: 12 hour light/dark rhythm;
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animals, left eyes remained untreated
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet
- Tool used to assess score: sodium fluorescein / ophthalmic lamp - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 110
- Reversibility:
- fully reversible within: complete after 6 days
- Remarks on result:
- other: additional time point after 1 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: complete after 6 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: complete after 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: complete after 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: complete after 6 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.17
- Iris: 0
- Conjunctivae (Redness): 0.50
- Conjunctivae (Chemosis): 0.22
- Overall irritation score: 3/110 - Other effects:
- REVERSIBILITY: complete after 6 days
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test item 1,5,9 -cyclododecatrien showed no irritant effects on eyes and mucosa of male and female rabbits which leads to no classification according to 67/548/EEC and according CLP regulation (1272/2008).
- Executive summary:
To test the acute irritant effect on eyes and mucosa the test item 1,5,9 -cyclododecatriene was administered undiluted into eyes or eyelid sacs of 3 male and 3 female rabbits. According to the study, the test item 1,5,9 -cyclododecatriene showed no irritant
effect on the eyes and mucosa of male and female rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
Three studies are available investigating the skin irritating potential of the test substance.
Firstly, the skin irritating potential of the test substance was analyzed by using six New Zealand White rabbits. No data on used guideline was available and study was not performed pre-GLP. Animals were exposed to the undiluted test substance applied to intact and abraded skin areas on the back. Observation time points were various and not specified. Average erythema score was minimal in abraded and intact skin of all rabbits. Average edema score was minimal in abraded akin of two rabbits at 24 hours. Effects were completely reversible after one week. Under the conditions chosen, the test substance showed minimal irritant reversible effects on the skin of rabbits which, however, were not sufficient for a classification according to Regulation (EC) 1272/2008 (1961, K2).
Secondly, the skin irritating potential of the test substance was analyzed by using rabbits, guinea pigs, and hairless mice. No data on used guideline was available and the study was performed pre-GLP. Animals were exposed to the undiluted test substance applied occlusively (rabbits) and open (rabbits, guinea pigs, mice). Observation time points were not specified. Postexposure period was three weeks for guinea pigs. Very severe irritation was observed for guinea pigs which did not fully recover within 21 days. With respect to conflicting results obtained in the other two studies described, the most likely explanation given by the authors was that the severe effects were caused by an aggressive impurity and thus the test substance was not classified according to Regulation (EC) 1272/2008 (1968, K4).
The skin irritating potential of the test substance was analyzed by using six Small White Russian rabbits. Animals were exposed for 4 hours to the undiluted test substance applied to a shaved area of ca. 6 cm². The test substance was then removed with distilled water. Observation time points were after 1, 24, 48, 72 hours and 6, 8, 11, and 14 days. Evaluation was based on 1-4 readings. The average scores of erythema, edema and overall irritation score were 1, 0.61 and 1.2, respectively established by combining time points 24/48/72 hours. Under the conditions chosen, the test substance showed a slightly irritant effect on the skin of male and female rabbits which, however, does not lead to a classification according to Regulation (EC) 1272/2008 (1983, K1).
Eye
Three studies are available investigating the eye irritating potential of the test substance.
Firstly, the eye irritating potential of the test substance was analyzed by using rabbits. No data on used guideline was available and the study was performed pre-GLP. Animals were exposed to the undiluted test substance. A single application of 0.1 ml with no specified exposure period was applied to the conjunctivae sac of the right eyes. The total observation period was one week and observation time points were 1, 24, 48, 72 hours and 1 week after treatment. The scoring system used was the one installed by Draize. The overall irritation scores after 1 hour, 24 h, 48 h, 72 h and 1 week were 6.6, 2.3, 1, 1, and 0, respectively (max 110). The test substance produced erythema of the palpebral conjunctiva, obvious swelling of the lids and nicititating mambrane and lacrimation within 1 hour. Effects were completely reversible within one week. The test substance showed only very mild reversible effects on eyes and mucosa of males and females. However, effects were not sufficient for a classification according to Regulation (EC) 1272/2008 (1961, K2).
Secondly, the eye irritating potential of the test substance was analyzed by using rabbits. No data on used guideline was available and the study was performed pre-GLP. No information on exposure period, observation period or concentration used were available. The substance was an immediate irritant but produced only a mild conjunctivitis which faded within 48 hours. Main effects were associated with the eye lids which became red and swollen and exuded a purulent discharge. Blepharitis was still apparent one week after application of the substance. With respect to the conflicting results obtained in other studies, the most likely explanations is that the severe effects were caused by an aggressive impurity (1968, K4).
Six male and female Small White Russian rabbits were exposed to the undiluted test substance. The study was performed according to OECD 4045 and was conducted pre-GLP. The amount applied to rabbit's eyes was 0.1 ml and the exposure period was 72 hours without rinsing. Ophtalmoscopic examinations were performed at 1, 24, 48 and 72 hours after treatment and the scoring system by Draize was used. Scores were evaluated using average time points of 24/48/72 hours. The overall irritation score was 3 (max 110), cornea opacity score was 0.17 (max 4), iris score was 0 (max 2), conjunctivae score was 0.5 (max 3), and chemosis score was 0.22. The test substance showed no irritant effects on eyes and mucosa of male and female rabbits (1983, K1).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008.
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