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EC number: 298-190-5 | CAS number: 93778-52-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.04.2002 - 17.05.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-decyltetradecanoic acid
- EC Number:
- 298-190-5
- EC Name:
- 2-decyltetradecanoic acid
- Cas Number:
- 93778-52-0
- Molecular formula:
- C24H48O2
- IUPAC Name:
- 2-decyltetradecanoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Isocarb 24
- Substance type: Product
- Lot/batch No.: ISC2403, 04058/MA
- Physical state: crystalline at ambient conditions
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S. p. A. (Como), Italy (supplier), P. O. A. D. A., Mandello Lario (Como),Italy (breeder)
- Age at study initiation: 9 – 11 weeks
- Weight at study initiation: about 2 kg
- Housing: Animals were individually housed in stainless steel cages measuring 69 x 45 x 51 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary. Throughout the study each cage was identified by a colour coded label recording the study number, animal number and the details of treatment. This colour coding matched the corresponding colour coded formulation container.
- Diet (e.g. ad libitum): commercially available antibiotic free pelleted laboratory diet (AItromin MSK, Altromin, D-32770 Lage, Postfach 1120, Germany) ad libitum throughout the study.
- Water (e.g. ad libitum): Animals were offered drinking water supplied to each cage via water bottles
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%.
- Air changes (per hr): 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 l 12
IN-LIFE DATES: From: To: 13.05.2002 - 17.05.2002
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): with 1 ml sterile water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: A 0.5 g aliquot of the supplied test item was reduced to a paste with 1.0 ml of sterile waterThe test article was applied undiluted.
- Area of exposure: The test substance was applied to a gauze patch (2.5 cm x 2.5 cm). The gauze square was then placed onto the animal's skin with the test item in direct contact with the skin. A strip of aluminium foil was placed over the treated site and the whole assembly held
in place by encircling the trunk of the animal ith a length of elastic adhesive bandage, this forming a semi-occlusive barrier.The patch was placed on the appropriate test field. A strip of aluminium foil was placed over the treated site and the whole trunk was wrapped with an elastic adhesive bandage.
- Occlusion: semi-occlusion
- Vehicle: none
- Postexposure period: 72 h
- Removal of test substance: After a period of 4 hours, the adhesive bandage and gauze patch were removed from the treated site of each animal which was cleaned by gentle swabbing of the skin with cotton wool soaked in water at approximate body temperature.
EXAMINATIONS
- Scoring system: according to OECD 404
- Examination time points: Skin reactions were read immediately and 1, 24, 48 and 72 hours after the end of the exposure period
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritation or other reaction was apparent on the treated skin of any animal.
- Other effects:
- Changes in body weight during the course of the study were not remarkable. There was no indication of a systemic effect of treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal irritation of 2-decyltetradecanoic acid was investigated in the rabbit. A 0.5 g aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a period of 4 hours. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours after the end of the exposure period. No irritation was apparent following a 4 hour period of exposure to the substance. These results indicate that the test substance has no irritant effect on the skin of the rabbit.
- Executive summary:
These results indicate that the test substance has no irritant effect on the skin of the rabbit.
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