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EC number: 448-300-4 | CAS number: 88642-03-9
- 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:
- 2003-10-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 448-300-4
- EC Name:
- -
- Cas Number:
- 88642-03-9
- Molecular formula:
- C16H28O
- IUPAC Name:
- (6E)-cyclohexadec-6-en-1-one; (7Z)-cyclohexadec-7-en-1-one; (8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 138 - 166 g
- Fasting period before study: overnight prior to dosing
- Housing: The rats were kept in transparent polycarbonate cages (macrolone type III, floor area 810 cm2) with two or three in each cage. The cages were cleaned and the bedding changed at least twice a week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3 °C
- Humidity: 55 +/- 15 %
- Air changes: 10 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 4 females (main study)
1 female (pre-test) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 30 min., 2, 4 and 6 hours after the administration and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
- Preliminary study:
- The animal included in the sighting study (animal No. 1) survived the treatment and showed slight signs of toxicosis. The rat had a normal body weight gain during the study period. It showed piloerection 30 min. after the application of the test item. After 2 and 4 hours a hunched posture and piloerection were observed, whereas the rat still showed only piloerection after 6 hours. From day 1 until the end of the observation period on day 14 the animal was free of any abnormalities. The post mortem inspection revealed no pathological abnormalities.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the female rats died on account of the treatment nor did they show marked signs of toxicosis.
- Clinical signs:
- other: Animals No. 2, No. 3, No. 4 and No. 5 showed a hunched posture and piloerection 30 min., 2 and 4 hours after the application of the test item. At animal No. 2 a tremor was additionally recorded after 4 hours. After 6 hours all four animals were marked wit
- Gross pathology:
- The gross necropsy of the animals revealed no pathological abnormalities.
Any other information on results incl. tables
Table 1 Body weight group mean values [g] – Main study
Dose mg/kg bw |
sex |
Day 0 |
Day 7 |
Day 14 |
||||||
2000 |
female |
mean |
SD |
n |
mean |
SD |
n |
mean |
SD |
n |
143 |
5 |
4 |
178 |
8 |
4 |
200 |
5 |
4 |
Table 2 Daily Observations – Main study
Animal No |
Dose mg/kg bw |
sex |
min |
hours after dosing |
Day after dosing |
|||||||||
30 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
|||
2 |
2000 |
Female |
BE |
BE |
BEK |
BEK |
BE |
A |
A |
A |
A |
A |
A |
A |
3 |
2000 |
Female |
BE |
BE |
BE |
BEK |
BE |
A |
A |
A |
A |
A |
A |
A |
4 |
2000 |
Female |
BE |
BE |
BE |
BEK |
BE |
A |
A |
A |
A |
A |
A |
A |
5 |
2000 |
Female |
BE |
BE |
BE |
BEK |
BE |
A |
A |
A |
A |
A |
A |
A |
Key to table 2
A Normal behaviour
B Piloerection
C Salivation
D Apathy
E Hunched posture/ abdominal rigidity
F Body weight loss or emaciation
G Vomitting
H Diarrhoea
I Constipation
J Compulsive behaviour/ Pruritus
K Tremor
L Paresis
M Discharge, abnormal
N Anaemia
O Blood around nose and eyes
P Dehydration
Q Dyspnea
R Cyanosis
S Ataxia
T Paralysis
U Comatose
V Moribund
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the LD50 of the test item was found to be greater than 2000 mg/kg bw/d.
- Executive summary:
The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Procedure", December 2001. The study was initiated with a sighting study, in which one female rat was given the test item in a 2000 mg/kg b.w. dose. Slight signs of toxicosis were observed in this rat. Based on the results from the sighting study the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment and showed signs of toxicosis ranging from slight to moderate.
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