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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 401-700-2 | CAS number: 3100-36-5 CYCLOHEXADECENON; CYCLOHEXADECENONE
- 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
In the key acute oral toxicity study in rats according to OECD guideline 401, the LD50 was higher than 10000 mg/kg bw.
In the key acute dermal toxicity study in rabbits according to OECD guideline 402, the LD50 was higher than 4600 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both sexes were investigated
- Age at study initiation: Not specified
- Weight at study initiation: Mean body weights of 205 g
- Fasting period before study: 16 hours before test started
- Housing: In groups of 5 males and 5 females in single cages
- Diet Ad libitum (laboratory standard diet Altromin)
- Water: Ad libitum
- Acclimation period: Not specified
- Microbiological status when known: SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 45-55
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 15 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item has been used undiluted after warmed up in a waterbath.
- Details on oral exposure:
- DOSAGE PREPARATION: The test item has been used undiluted after warmed up in a waterbath.
- Doses:
- 5,000 mg/kg bw and 10,000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 hours, 48 hours, 7 days and 14 days after dosing
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: Appearance and behavior, reflexes, coat, cutaneous turgor, mucosae, faeces, body weights, food and water uptake, acute symptoms - Statistics:
- LD50 oral according to Litchfield & Wilcoxon. 24-hours and 14-days LD50 slope function not measurable.
- Preliminary study:
- Doses were chosen on account of an informational pre-test.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occured
- Clinical signs:
- other: In all dosage groups the preparation did not cause any remarkable symptoms.
- Gross pathology:
- Slight intestinal hyperaemia in 5 of 10 animals in the highest dosage in final autopsy could be
observed, possibly due to volume. No other macroscopical pathological changes could be observed. - Other findings:
- No other findings were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats according to OECD guideline 401, the LD50 was higher than 10,000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to OECD guideline 401 and GLP, the test item has been tested after one oral application in the rat. Under the conditions of the experiment, the following results have been determined: The 24 hour-LD50 and 14 days LD50 of the product has been found at higher than 10,000 mg/kg body weight. Body weights did not point to incompatibility. Clinical picture did not show alterations to normal findings. In the final autopsy, no clear anatomic pathological changes occurred. Slight intestinal hyperemia in 5 out of 10 animals in the highest dosage could be observed. Therefore, the product can be considered as nearly harmless (nontoxic).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- > 10 000 mg/kg bw
- Quality of whole database:
- Reliable without restrictions (RL1)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-08-12 to 1987-03-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- According to OECD 402 and GLP, but individual animal results not provided in the report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- According to OECD 402 and GLP, but individual animal results not provided in the report.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino rabbits
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both sexes were investigated
- Age at study initiation: Young adult
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: Individually in suspended, galvanized cages, fitted with wire-mesh floor and front. Throughout the 24-hour exposure period the animals were kept in restraining boxes.
- Diet: Ad libitum (standard laboratory rabbit diet), except for 24 hours exposure period
- Water: Ad libitum
- Acclimation period: Approx. 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): At least 40
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 15 - Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test substance was melted at approx. 35°C
- Details on dermal exposure:
- TEST SITE
- % coverage: Approx. 10
- Type of wrap used: The treated skin area of the rabbits was covered with a thin layer of cellulose sheet and wrapped in polyethylene foil.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed from the skin with an appropriate solvent.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 5 mL/kg bw
- Concentration: The test substance was applied in pure form
- Constant volume or concentration used: No - Duration of exposure:
- 24 hours
- Doses:
- 5 mL/kg bw
- No. of animals per sex per dose:
- 5 animals per sex were treated with a single dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded on day 0 (day of dosing), 8 and 15 (day of autopsy). Mortality was recorded with the time and cause of death as precisely as possible.
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: All visible reactions to treatment observed during the 24-hour exposure period and during the subsequent two-week period were recorded.
- Other examinations performed: Clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 600 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No rabbits died during the 24-hour exposure period. On day 2, one rabbit was found dead.
- Clinical signs:
- other: Local effects: During and/or at the end of the 24-hour exposure period treatment-related dermal effects consisted of slight erythema and slight oedema. The following local skin reactions were recorded for all rabbits during the 14-day observation period:
- Gross pathology:
- The autopsy findings in all animals (also in the animal that died) were normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo acute dermal toxicity study in rabbits according to OECD guideline 402, the LD50 was higher than 4600 mg/kg bw.
- Executive summary:
A sample of the test substance was examined for its acute dermal toxicity in a limit test with albino rabbits according to OECD guideline 402 and GLP. Five male and five female rabbits were dermally treated with 5.0 mL/kg body weight. The exposure period was 24 hours. Acute local skin reactions consisted of slight erythema and slight oedema. At the end of week 1, moderate to severe scaliness and some slight incrustation were observed, and at the end of week 2 (at autopsy), slight to severe scaliness. The only sign of acute toxicity consisted of slight apathy which was observed in two rabbits. One male rabbit died but autopsy findings were normal. There was some growth retardation during week 1 but during week 2, growth was normal. Apart from the slight local skin effects mentioned above, terminal autopsy findings were normal. On the basis of the results obtained, it was concluded that the substance is not considered to be harmful in contact with skin, the dermal LD50 value being higher than 4600 mg/kg bw (5.0 mL/kg bw).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- > 4 600 mg/kg bw
- Quality of whole database:
- Reliable with restrictions (RL2): According to OECD 402 and GLP, but individual animal results not provided in the report.
Additional information
Key, Acute oral toxicity, RL1
In an acute oral toxicity study according to OECD guideline 401 and GLP, the test item has been tested after one oral application in the rat. Under the conditions of the experiment, the following results have been determined: The 24 hour-LD50 and 14 days LD50 of the product has been found at higher than 10,000 mg/kg body weight. Body weights did not point to incompatibility. Clinical picture did not show alterations to normal findings. In the final autopsy, no clear anatomic pathological changes occurred. Slight intestinal hyperemia in 5 out of 10 animals in the highest dosage could be observed. Therefore, the product can be considered as nearly harmless (nontoxic).
Key, Acute dermal toxicity, RL2
A sample of the test substance was examined for its acute dermal toxicity in a limit test with albino rabbits according to OECD guideline 402 and GLP. Five male and five female rabbits were dermally treated with 5.0 mL/kg body weight. The exposure period was 24 hours. Acute local skin reactions consisted of slight erythema and slight oedema. At the end of week 1, moderate to severe scaliness and some slight incrustation were observed, and at the end of week 2 (at autopsy), slight to severe scaliness. The only sign of acute toxicity consisted of slight apathy which was observed in two rabbits. One male rabbit died but autopsy findings were normal. There was some growth retardation during week 1 but during week 2, growth was normal. Apart from the slight local skin effects mentioned above, terminal autopsy findings were normal. On the basis of the results obtained, it was concluded that the substance is not considered to be harmful in contact with skin, the dermal LD50 value being higher than 4600 mg/kg bw (5.0 mL/kg bw).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute oral and dermal toxicity, the test item is not classified and labelled according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
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.