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EC number: 206-376-4 | CAS number: 334-48-5
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Oct - 03 Nov 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted in Jul 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Federal Office of Public Health, the Swiss Agency for Therapeutic Products and the Swiss Agency for the Environment, Forests and Landscape, Switzerland
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Decanoic acid
- EC Number:
- 206-376-4
- EC Name:
- Decanoic acid
- Cas Number:
- 334-48-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- decanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: males: 8 weeks; females: 11 weeks
- Weight at study initiation: males: 264.7-273.6 g; females: 192.7-214.2 g
- Housing: individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation
- Diet: pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: community tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10 Oct 2006 To: 03 Nov 2006
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin of the back
- % coverage: 10
- Type of wrap if used: The test item was covered with a semiocclusive dressing, which was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 mL/kg bw
- Concentration (if solution): 0.25 g/mL
- Dose Formulation: The test item was prepared in the vehicle, PEG 300, to ensure good skin contact. The test item was weighed into a tared glass beaker and the vehicle added (w/v). The formulation was prepared shortly before the application using either a magnetic stirrer and a spatula alone or combined to an Ultra-Turrax as homogenizers. Consistency of dose formulation was considered suitable for dermal application. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical signs were performed during the first 30 minutes and at approx. 1, 2, 3 and 5 h after administration on test day 1. Thereafter observations for mortality were performed twice daily and for clinical signs once daily, respectively. Body weights were determined on test day 1 (prior to administration) and on days 8 and 15. Local signs were looked at once daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: 4/5 males and 3/5 females were found slightly or moderately sedated on day 2 of the study after patch removal. Furthermore, at this time point 3 males and 2 females showed deep respiration and 3 males and 1 female revealed hunched posture. From day 3 on n
- Gross pathology:
- No macroscopic findings were noted at necropsy.
- Other findings:
- After removal of the dressing, slight to moderate erythema was noted in all animals. The local effects developed into slight to moderate scaling in all animals and slight scabs were observed in all animals except one female. Scaling and/or scabs were reversible within day 5 and 13 in the animals (see table 1).
Any other information on results incl. tables
Table 1: local signs observed after test substance application for 24 h
Animal No. (sex) |
Local effect |
Test days |
|||||||||||||
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||
1 (m) |
erythema |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
scaling |
- |
2 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
2 (m) |
erythema |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
scaling |
- |
2 |
2 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
3 (m) |
erythema |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
scaling |
- |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
4 (m) |
erythema |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
scaling |
- |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
5 (m) |
erythema |
2 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
scaling |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
6 (f) |
erythema |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
scaling |
- |
2 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
7 (f) |
erythema |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
scaling |
1 |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
8 (f) |
erythema |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
scaling |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
|
9 (f) |
erythema |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
scaling |
- |
- |
1 |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
- |
- |
|
10 (f) |
erythema |
1 |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
scaling |
- |
2 |
2 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
scabs |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
1: sligth; 2: moderate: -: no local finding
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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