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EC number: 204-263-4 | CAS number: 118-60-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16-29 May 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant OECD404 guideline study without significant deviations
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 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethylhexyl salicylate
- EC Number:
- 204-263-4
- EC Name:
- 2-ethylhexyl salicylate
- Cas Number:
- 118-60-5
- Molecular formula:
- C15H22O3
- IUPAC Name:
- p-menth-1-en-8-ol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Sex, species, strain: male New Zealand White rabbits.
Breeder: Grimaud freres selection S.A.S., La Corbiere, Roussay, France.
Number: three animals were used, as recommended by the international guidelines.
Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body
weight istandard deviation of2.6 i0.1 kg.
Acclimation: at least 5 days before the beginning ofthe study.
Identication: individual metal ear tag.
The conditions in the animal room were set as follows:
. temperature: 18 ± 3° C
. relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour ofltered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and led. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were veried and calibrated at regular intervals.
The animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm).
Each cage was equipped with a food container and a water bottle.
During the study, the animals had free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France). Food was analyzed regularly by the supplier for composition and contaminant levels. Drinking water ltered by a FG Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses ofwater are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides, heavy metals and nitrosamines). No contaminants were known to have been present in the diet or drinking water at levels which may be expected to have interfered with or prejudiced the outcome ofthe study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin served as control.
- Amount / concentration applied:
- Doses of 0.5 mL of the undiluted test item were placed on a dry gauze, which was then applied to an area of approximately 6 cm2 of the anterior left ank (application for 3 minutes), the anterior right ank (application for l hour) or the posterior right ank (application for 4 hours) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
The untreated skin served as control. No residual test item was observed on removal ofthe dressing. - Duration of treatment / exposure:
- 3 minutes on anterior left ank, 1 hour on anterior right ank and 4 hours on posterior right ank
- Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. Since there were persistent irritation reactions (dryness) at 72 hours in animal No. 697 (anterior left ank), the observation period was extended up to their complete reversibility (Le. day 14).
- Number of animals:
- 3 male animlas
- Details on study design:
- Criteria for irritation
A substance or a preparation is considered to be irritating to the skin if, when it is applied to healthy intact animal skin for up to 4 hours, significant inammation is caused and which persists for 24 hours or more after the end of the exposure period.
Criteria for corrosion
A substance or a preparation is considered to be corrosive if, when it is applied to healthy intact animal skin, it produces full thickness destruction of skin tissue on at least one animal during the test for skin irritation, or if the result can be predicted (for example: from strongly acid or alkaline reactions).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 4 hours exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 4 hours exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 4 hours exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 4 hours exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 4 hours exposure
- Irritant / corrosive response data:
- A well defined erythema (grade 2) was noted 1 h after removal of patches but reversed to grade 0 within 24 hours in 2 animals and within 48 hours in one animal.
- Other effects:
- Following 3 minutes exposure dryness of the skin was noted from day 4 up to day 13.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these experimental conditions, the test item SALICYLATE D'OCTYLE was slightly irritant when applied topically to rabbits. A classification according to CLP/DSD however is not required.
- Executive summary:
In this study 3 animals were exposed topically to 2-ethylhexyl salicylate over a period of 3 minutes, 1 hour and 4 hours respectively. One hour following removal of the patches slight erythrema were noted at the sites exposed to 3 minutes and 1 hour wereas the erythema were well-defined (grade 2) where exposed for 4 hours. However, all erythema fully reversed within 24 hours and onyl in one animal following 48 hours. No Edema were recorded in any of the animals at any time. Dryness of skin was noted in one animal following 3 minutes exposure but this fully reversed within 14 days. Thus, the test item was considered non-irritant following the CLP (Regualtion EC No 1272/2008) classification system
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