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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20.05. - 23.05.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S. p. A. (Como) (supplier), P.O.A.D.A. Mandello Lario (CO) (breeder), Italy
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 1.8 - 2.3 kg
- Housing: Animals were individually housed in stainless steel cages measuring 69x45x51 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): a commercially available anti-biotic free pelleted laboratory diet (Altromin 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: 10 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: 08.04.2002 - 23.05.2002
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye
- Amount / concentration applied:
- - Amount of substance instilled: 0.1 g into the right eye
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test substance was applied undiluted.
- Amount of substance instilled: 0.1 g
- Vehicle: none
- Postexposure period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: the treated eye examined macroscopically for damage or irritation to the cornea, iris and conjunctivae using the untreated eye as a comparator control.
- Scoring system: according to OECD 405
- Observation period: Ocular reactions were recorded 1, 24, 48 and 72 h after application.
- Tool used to assess score: not mentioned
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- Slight redness was noted in 1 animal at the 1 hour examination. No reaction to treatment was observed at the 24, 48 or 72 hour post-dose examinations.
- Other effects:
- There was no indication of a systemic effect of treatment. Changes in body weight during the course of the study were not remarkable.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute eye irritation of the test substance was investigated in the rabbit. A 0.1 g aliquot of the substance was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours after dosing. Slight redness was noted in 1 animal at the 1 hour examination. No irritation was apparent at the 24, 48 or 72 hour post-dose examinations. The results of this study indicated that the test item has no significant irritant effect in the eye.
- Executive summary:
The results of this study indicated that the test item has no significant irritant effect in the eye.
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