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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 273-295-9 | CAS number: 68955-98-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- The percutaneous absorption of some anionic surfactants
- Author:
- Howes, D.
- Year:
- 1 975
- Bibliographic source:
- J. Soc. Cosmet. Chem. 26:47-63
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- Turnover of [14C] surfactants in the rat
- GLP compliance:
- no
Test material
- Reference substance name:
- Decanoic acid (C10:0), Dodecanoic acid (C12:0), Tetradecanoic acid (C14:0), Hexadecanoic acid (C16:0), Octadecanoic acid (C18:0)
- IUPAC Name:
- Decanoic acid (C10:0), Dodecanoic acid (C12:0), Tetradecanoic acid (C14:0), Hexadecanoic acid (C16:0), Octadecanoic acid (C18:0)
- Details on test material:
- - Name of test material (as cited in study report): Decanoic acid (C10:0), Dodecanoic acid (C12:0), Tetradecanoic acid (C14:0), Hexadecanoic acid (C16:0), Octadecanoic acid (C18:0)
- Analytical purity: Pure biochemical grade
- Specific activity (if radiolabelling): 14 mCi/mM
- Locations of the label (if radiolabelling): 1-Alkyl position with 14C (1-14C)
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 100-120 g
- Individual metabolism cages: yes
Administration / exposure
- Route of administration:
- other: intraperitoneal (3 animals) and subcuntaneous (3 animals)
- Vehicle:
- other: The test materials were applied as soap solutions (sodium salts).
- Duration and frequency of treatment / exposure:
- 6 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
C10:0: ca. 1.09 mg/kg bw
C12:0: ca 1.18 mg/kg bw
C14:0: ca. 1.36 mg/kg bw
C16:0: ca. 1.55 mg/kg bw
C18:0: ca. 1.64 mg/kg bw
- No. of animals per sex per dose / concentration:
- 6: 3 animals injected intraperitoneally, 3 animals injected subcutaneously
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (excretion)
- Tissues and body fluids sampled: urine, faeces, expired air
- Time and frequency of sampling: single sampling at 6 h post-application
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- The rate and route of excretion of 14C from intraperitoneally administered [14C] surfactant solutions were the same as that from subcutaneously administered solutions. The recoveries are given in Table 1 (see remarks on results).
These results showed that at 6 h after administration, the C10:0 and C12:0 soaps were readily metabolized and the main route of excretion was as 14CO2, The C14:0 soap was readily incorporated into the body and the 14C excretion was slow. The C16:0 and C18:0 soaps showed some metabolism with subsequent 14CO2 excretion but most of the 14C was recovered in the carcass at 6 h. From the results the route of excretion of 14C surfactant giving the most sensitive indication of percutaneously absorbed surfactant was indicated.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Table 1. Recoveries of 14C from rats after injection with [14C] surfactants.
|
Dose |
% Applied dose |
||||
[14C] Surfactant |
µCi |
(mg) |
CO2 |
Urine |
Faeces |
Carcass |
C10:0 |
7.25 |
0.12 |
57 ± 5 |
< 0.1 |
< 0.1 |
37 ± 6 |
C12:0 |
10.49 |
0.13 |
65 ± 7 |
< 0.1 |
< 0.1 |
30 ± 7 |
C14:0 |
8.13 |
0.15 |
5 ± 3 |
2.1 ± 1.2 |
< 0.1 |
85 ± 9 |
C16:0 |
7.74 |
0.17 |
21 ± 4 |
< 0.1 |
< 0.1 |
71 ± 8 |
C18:0 |
8.49 |
0.18 |
38 ± 9 |
< 0.1 |
< 0.1 |
56 ± 16 |
Each result is the mean from six animals ± SD – three animals injected intraperitoneally and three animals subcutaneously. The collection time was 6 h after injection.
Applicant's summary and conclusion
- Conclusions:
- The turnover of the [14C] surfactants in the rat showed that there was no significant difference in the rate or route of excretion of 14C given by intraperitoneal or subcutaneous administration. The main route of excretion was as 14CO2 in the expired air at 6 h after administration. The remaining material was incorporated in the body. Longer fatty acid chains are more readily incorporated than shorter chains. At ca. 1.55 and 1.64 mg/kg bw, 71% of the C16:0 and 56% of the C18:0 was incorporated and 21% and 38% was excreted as 14CO2, respectively.
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.