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EC number: 269-122-1 | CAS number: 68187-75-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end on 22nd April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oils, fish, oxidized
- EC Number:
- 269-122-1
- EC Name:
- Oils, fish, oxidized
- Cas Number:
- 68187-75-7
- Molecular formula:
- Not necessary
- IUPAC Name:
- Triglycerides C12-24, even, saturated and unsaturated, oxidized
- Details on test material:
- - Name of test material (as cited in study report): Triglycerides, C12-24, saturated and unsaturated, oxidized- Substance type: UVCB- Physical state: liquid- Stability under test conditions: data not available- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River Deutschlan GmbH, D-88353, Kisslegg- Age at study initiation: 13 to 15 months- Weight at study initiation: 2.8 - 2.9 kg- Housing: individually in PPO cages (floor area: 2576 cm2) with perforated floor- Diet: a pelleted complete rabbit diet "Altromin 2123", ad libitum- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.- Acclimation period: at least one weekENVIRONMENTAL CONDITIONS- Temperature: 20 +/- 3°C- Humidity: 30 - 70%- Air changes: 10 times/hour- Photoperiod: 12 hrs dark / 12 hrs lightIN-LIFE DATES: From 27 October 2009 to 06 November 2009
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied: 0.5 mL- Concentration: undiluted
- Duration of treatment / exposure:
- 1st rabbit: 3 minutes, 1 hour and 4 hours2nd and 3rd rabbits: 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE- Area of exposure: 2.5cm x 2.5 cm- % coverage: data not available - Type of wrap if used: gauze patch secured with semi-occlusive adhesive Gotaplast tapeREMOVAL OF TEST SUBSTANCE- Washing (if done): with mild soap and lukewarm water- Time after start of exposure: 3 minutes, 1 hour or 4 hoursSCORING SYSTEM: according to OECD 404 guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Any skin reaction were not observed 1h, 24h, 48h and 72h after the termination of the application.
- Other effects:
- The animal used in the initial test showed a slight yellow coloration on the posterior right test field only, which was probably caused by the test item.
Any other information on results incl. tables
Table 1 : Results
Animal No. |
Exposure time |
Test field |
erythema |
edema |
|||||||||||
0h |
1h |
24h |
48h |
72h |
mean |
0h |
1h |
24h |
48h |
72h |
Mean |
||||
4347 |
3min |
Anterior right |
0 |
0 |
0 |
0 |
0 |
|
0 |
0 |
0 |
0 |
0 |
|
|
1h |
Middle right |
0 |
0 |
0 |
0 |
0 |
|
0 |
0 |
0 |
0 |
0 |
|
||
4h |
Posterior right |
0 |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0 |
0.00 |
||
4346 |
4h |
Anterior right |
|
0 |
0 |
0 |
0 |
0.00 |
|
0 |
0 |
0 |
0 |
0.00 |
|
4348 |
4h |
Anterior right |
|
0 |
0 |
0 |
0 |
0.00 |
|
0 |
0 |
0 |
0 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Triglycerides, C12-24, saturated and unsaturated, oxidized is not irritating to the skin in rabbit
- Executive summary:
In a primary dermal irritation study according to OECD 404 and GLP, 3 female albino rabbits were dermally exposed to 0.5 mL of undiluted triglycerides, C12-24, even, saturated and unsaturated, oxidized for 4 hours to 2.5cmx2.5cm of the right back area. Animals then were observed for 3 days. Irritation was scored according to OECD method.
Under the experimental conditions, the mean scores for erythema and edema were 0.00.
In this study, triglycerides, C12-24, even, saturated and unsaturated, oxidized is not a dermal irritant. The substance is not classified according to Directive 67/548/EEC or CLP criteria.
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