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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 833-435-7 | CAS number: 2133415-29-7
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP and no guideline followed but well conducted and well described study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Remarks:
- Not specified
Test material
- Reference substance name:
- Icosane
- EC Number:
- 204-018-1
- EC Name:
- Icosane
- Cas Number:
- 112-95-8
- Molecular formula:
- C20H42
- IUPAC Name:
- icosane
- Details on test material:
- - Name of test material (as cited in study report): eicosane
- Analytical purity: analytical quality
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: EVIC CEBA, Guainville, France
- Weight at study initiation: 200 g
- Housing: no data
- Diet (e.g. ad libitum): standard diet (fish flour) ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- arachis oil
- Details on exposure:
- No data
- Duration and frequency of treatment / exposure:
- Préliminary experiment: daily for 7 days
Main experiment: daily for 6 months
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Preliminary experiment: 15 mg/day
Main experiment: 0.1%
- No. of animals per sex per dose / concentration:
- Preliminary experiment: 3 rats
Main experiment: 30 rats periodically sacrified in groups of 3 - Control animals:
- yes, concurrent no treatment
- Positive control reference chemical:
- None
- Details on study design:
- 30 animals were fed at 0.1% icosane for 6 months. Then, 2 groups were made: one fed with standard diet and one with energy-restricted diet.
- Details on dosing and sampling:
- Preliminary experiment: the 3 rats were sacrified the 10th day and liver, spleen, heart, kidneys, lungs, muscle and fat were collected. The rest of the carcass was grinded and lyophilised.
Main experiment: groups of 3 animals were sacrified at 8, 15 days and 1, 2, 3 and 6 months. Icosane administration was stopped 3 days before. Mesenteric and epididymal adipose tissue, liver and muscles from the hind limbs were collected. The rest of the carcass was grinded and lyophilised. - Statistics:
- None
Results and discussion
- Preliminary studies:
- Adipose tissue is the main site of retention, corresponding to 7.2% of the total amount of icosane ingested (see table 1).
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- No data
- Details on distribution in tissues:
- Icosane preferentially locates in fat and its increase parallels the increase in total fat due to growth. Icosane / total fat ratio is rather constant, between 6 to 8 ppm/g.
- Details on excretion:
- Repeated administration of icosane for several months led to retained amounts corresponding to 6.6% of the total amount ingested.
Icosane was slowly eliminated as after 6 months of "recovery", only 1/3 of icosane was eliminated from fat tissue. In light fed rats, icosane was mobilised as concentration in fat drastically increased in the first months but was no more detectable at 6 months.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- No data
Any other information on results incl. tables
Table 1: Icosane content in tissues and organs in the preliminary experiment
|
Icosane (µg/g of fresh tissue) |
Liver |
2.6 |
Heart |
3.6 |
Spleen |
13.5 |
Lungs |
11.8 |
Kidneys |
24.5 |
Muscle |
34.3 |
Fat |
317.0 |
Table 2: Icosane content in tissues and organs during prolonged exposure
|
Live weight
(g) |
Total lipids
(g) |
Total carcass
(µg of icosane / g of tissue) |
Liver
(µg of icosane / g of tissue) |
Muscle
(µg of icosane / g of tissue) |
Fat
(µg of icosane / g of tissue) |
0.1% icosane in diet |
||||||
8 days |
264 |
35.9 |
63 |
54.7 |
17.4 |
266 |
15 days |
359 |
574 |
84 |
3.3 |
31.3 |
374 |
1 month |
342 |
61 |
116 |
4.7 |
24.2 |
494 |
2 months |
460 |
94.8 |
259 |
4.7 |
28.1 |
684 |
3 months |
509 |
110.3 |
373 |
10.7 |
56.8 |
1 029 |
6 months |
580 |
154 |
635 |
17.2 |
64.1 |
1 172 |
Light diet |
||||||
4 months |
336 |
24 |
471 |
8.0 |
299 |
8 559 |
6 months |
316 |
12.7 |
162 |
1.7 |
40.8 |
‑ |
Standard diet |
||||||
6 months |
571 |
148.7 |
353 |
10.1 |
59.7 |
738.4 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: high bioaccumulation potential based on study results
Carcass retention of the amounts ingested is about 7%; preferential fixation occurs in adipose tissue.
Only 1/3 of the amount stored in fat disappears in 6 months.
If the animals are fed an energy-restricted diet, mobilization of stored hydrocarbon, although more pronounced, occurs at a lower rate than stored lipid mobilization. - Executive summary:
Accumulation of eicosane was observed over 6 months in rats fed a diet containing 0.1% of icosane. At 6 months, carcass retention of the amounts ingested is about 7%; preferential fixation occurs in adipose tissue. If hydrocarbon administration is discontinued, mobilization is slow since only 1/3 of the amount stored disappears in 6 months. Finally, if the animals are fed an energy-restricted diet, mobilization of stored hydrocarbons, although more pronounced, occurs at a lower rate than stored lipid mobilization.
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.