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EC number: 946-245-5 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 September 1980 to 22 September 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of (E)-3,4,5,6,6-pentamethylhept-3-en-2-one and 3,5,6,6-tetramethyl-4-methyleneheptan-2-one
- EC Number:
- 946-245-5
- Molecular formula:
- C12H22O
- IUPAC Name:
- Reaction mass of (E)-3,4,5,6,6-pentamethylhept-3-en-2-one and 3,5,6,6-tetramethyl-4-methyleneheptan-2-one
- Test material form:
- liquid
- Details on test material:
- According to ECHA communication with reference to Annotation number: SUB-C-2114629169-42-01/F, the substance ID for Koavone has been changed with EC# from 939-627-8 to 946-245-5, and the IUPAC name from Reaction mass of (3R,5R)-3,5,6,6-tetramethyl-4-methylideneheptan-2-one and (3R,5S)-3,5,6,6-tetramethyl-4-methylideneheptan-2-one and (E)-3,4,5,6,6-pentamethylhept-3-en-2-one to Reaction mass of (E)-3,4,5,6,6-pentamethylhept-3-en-2-one and 3,5,6,6-tetramethyl-4-methyleneheptan-2-one.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Inc
- Age at study initiation: Approximately 6 weeks
- Weight at study initiation: The male rats was 155 to 200 g and for the female rats was 123 to 150 g
- Fasting period before study: Yes, approximately 19-20 hours overnight prior to dosage
- Housing: The rats were housed in groups (4-5 of like sex) in stainless steel wire mesh cages suspended above the droppings
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 5 September 1980 to 19 September 1980
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: alcohol SD39C
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 0.7 mL/ 100 g bw - Doses:
- 0.59, 1.00, 1.69, 2.88, and 5.0 g/kg of bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Closely observations for gross signs of systemic toxicity and mortality: At approximately 1-2, 3-4, 4-6 and 21-23 hours after treatment during the day of dosing, and twice daily thereafter for a total of 14 days.
- Necropsy of survivors performed: yes
- The protocol specified observations at 1, 3, 5 and 24 hours on the day of treatment.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 6.1 other: g/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3.51 - < 10.6
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2.35 other: g/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1.31 - <= 4.21
- Mortality:
- The following deaths occurred within the first six days after the animals were treated with all but one occurring within the first three days:
0.59 g/kg bw: 2 females
1.00 g/kg bw: 3 females,
1.69 g/kg bw: 1 male and 4 females
2.88 g/kg bw: 2 males and 5 females
5.00 g/kg bw: 4 males and 7 females - Clinical signs:
- other: Clinical changes included central nervous system depression (accompanied by changes such as loss of righting reflex, uncoordinated movement, partially closed eyelids, altered breathing and salivation) in all animals and bloating in males. At dosage of 0.5
- Gross pathology:
- Most of the animals that died during the course of the study exhibited staining about the mouth and nose externally. Internally, gas in the intestines and morphologic changes in the kidneys and liver were frequently present. Gross necropsies performed at the termination of the study were uneventful except for the presence of gas in the intestines and stomach of a few rats. No other gross pathology was seen.
Any other information on results incl. tables
Table 1. Mortality during the 14- day observation period.
Dosage |
Sex |
Hours |
Days |
||||||||
g/kg |
|
1 |
3 |
5 |
1 |
2 |
3 |
4 |
5 |
6 |
7-14 |
0.59 |
M |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0.59 |
F |
0/10 |
0/10 |
1/10 |
1/10 |
2/10 |
2/10 |
2/10 |
2/10 |
2/10 |
2/10 |
1.00 |
M |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
1.00 |
F |
2/10 |
2/10 |
2/10 |
2/10 |
3/10 |
3/10 |
3/10 |
3/10 |
3/10 |
3/10 |
1.69 |
M |
0/10 |
0/10 |
0/10 |
0/10 |
1/10 |
1/10 |
1/10 |
1/10 |
1/10 |
1/10 |
1.69 |
F |
1/10 |
1/10 |
1/10 |
1/10 |
3/10 |
4/10 |
4/10 |
4/10 |
4/10 |
4/10 |
2.88 |
M |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
2/10 |
2/10 |
2/10 |
2/10 |
2/10 |
2.88 |
F |
0/10 |
0/10 |
0/10 |
0/10 |
4/10 |
4/10 |
4/10 |
4/10 |
5/10 |
5/10 |
5.00* |
M |
0/10 |
0/10 |
0/10 |
0/10 |
2/10 |
3/10 |
4/10 |
4/10 |
4/10 |
4/10 |
5.00 |
F |
0/10 |
0/10 |
0/10 |
1/10 |
3/10 |
7/10 |
7/10 |
7/10 |
7/10 |
7/10 |
* Data on all 10 rats included
- Values are number of animals dead/number of animals tested, cumulative.
Applicant's summary and conclusion
- Interpretation of results:
- other: not harmful
- Remarks:
- in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- Not harmful. In an acute oral toxicity study which was performed according to a method similar to OECD TG 401, the acute oral LD50 was found to be 6.10 g/kg bw for males with a 95% confidence limit of 3.51 - 10.6 g/kg, and 2.35 g/kg bw for females with a 95% confidence limit of 1.31 - 4.21 g/kg.
- Executive summary:
The acute oral toxicity of the substance was evaluated in male and female Sprague-Dawley derived albino rats (10 animals per sex per dose), using a method similar to OECD TG 401. The animals were treated with the following dosages: 0.59, 1.00, 1.69, 2.88, and 5.0 g/kg bw by gavage. Gross signs of systemic toxicity, mortality, bodyweight was determined. Gross necropsy was performed after the 14- day observation period.
Deaths occurred within six days after treatment. Central nervous system depression was present in all groups after treatment. All animals which survived the observation period gained weight. Necropsies of animals which died revealed staining around the mouth, gas in the intestinal tract and changes in the kidneys and livers in most animals while necropsies of animals at the end of the observation period were generally uneventful. The acute oral LD50 was found to be 6.10 g/kg bw for male Sprague-Dawley derived albino rats with a 95% confidence limit of 3.51 - 10.6 g/kg. The LD50 for female Sprague-Dawley derived albino rats was found to be 2.35 g/kg bw with a 95% confidence limit of 1.31 - 4.21 g/kg.
Based on these results, the test substance is not harmful in accordance with EU CLP (EC no 1272/2008 and its amendments).
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