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EC number: 279-348-2 | CAS number: 79915-74-5
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 September 2015 - 22 December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- adopted 22 July 2010
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- 2-isopropoxyethyl salicylate
- EC Number:
- 279-348-2
- EC Name:
- 2-isopropoxyethyl salicylate
- Cas Number:
- 79915-74-5
- Molecular formula:
- C12H16O4
- IUPAC Name:
- 2-(propan-2-yloxy)ethyl 2-hydroxybenzoate
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: Clear colorless liquid
- Storage Conditions: Room temperature, in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:JN
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain: Mice, CBA/JN
Sex: Females (nulliparous and non-pregnant)
Age: Approximately 8 weeks old, approximately 25 grams
Supplier: Charles River Italia S.p.A., Calco (Lecco), Italy
Breeder: Charles River France Laboratories, Iffa Credo, Domaine des Oncins B.P. 0109, F 69592, L’ARBRESLE CEDEX, France.
Weight range at arrival: 18 to 23 grams
Acclimatisation period: At least 5 days
Environmental condition:
Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes: Approximately 15 to 20 air changes per hour
Temperature range: 22 °C +/- 2 °C
Relative humidity range: 55%+/-15%
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/diethyl phthalate 1:3 (v/v) as vehicle
- Concentration:
- Main Assay: 100, 50 and 25% (w/w)
Preliminary assay: 100, 50, 25, 10 and 5% (w/w) - No. of animals per dose:
- 5 animals for dose
- Details on study design:
- PRE-SCREEN TESTS:
- Irritation: The treated sites of all animals were examined daily (once before first dosing, before dosing on Days 2 and 3 and daily thereafter).
- Systemic toxicity: The animals were observed for clinical signs on: Day 1: before and 1 hour after dosing. Day 2 to 6: daily (approximately 1 hour after daily dosing, when applicable).
- Ear thickness measurements: The ear thickness was measured by a suitable micrometer on Day 1 (before dosing), on Day 3 (before dosing) and on Day 6.
- Erythema scores: Irritation to the skin was assigned a numerical value according to the the OECD guideline.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LOCAL LYMPH NODE ASSAY (LLNA: BrdU-ELISA method)
- Criteria used to consider a positive response: The test item is considered to induce sensitisation when the SI for any single treatment dose group is >/= 1.6. It is not required that an increased response is observed at increasing dose levels, but dose-related activity and/or statistical significance may be taken as further evidence of a sensitisation effect (i.e. in case of borderline results with 1.6 <= SI <= 1.9).
TREATMENT PREPARATION AND ADMINISTRATION:
The animals were treated for three consecutive days (Days 1, 2, 3) with the vehicles, test or positive control item formulations. A dose volume of 25 μL/ear/day of each selected concentration and controls was applied to the dorsal surface of each ear (50 μL/animal/day), using a micropipette. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Differences between each treated group and the concurrent negative control group (individual BrdU labelling indices) were assessed by Dunnett’s test. The homogeneity of the data was verified by Bartlett’s test before Dunnett’s test. If data were found to be inhomogeneous a Modified t test (Cochran and Cox) was applied.
Results and discussion
- Positive control results:
- In the group treated with the positive control item, a Stimulation Index of 2.43 was calculated. As it was greater than 2, the study was regarded as valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.63
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 2.23
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 2.46
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Dose-related increases in cell proliferation of draining lymph nodes, significant at statistical analysis at the 2 higher concentrations, were observed in the three treatment groups.
DETAILS ON STIMULATION INDEX CALCULATION
The calculated Stimulation Indices (SI) were 1.63, 2.23 and 2.46, respectively at low, mid- and high dose levels (25%, 50% and 100% (w/w)).
CLINICAL OBSERVATIONS:
No mortality or clinical signs were recorded in animals treated at all dose levels investigated.
BODY WEIGHTS:
Changes in body weight observed during the study were within the expected range for this strain and age of animals.
Any other information on results incl. tables
In the preliminary study, no signs of toxicity (significant clinical signs or body weight losses) were observed at the tested concentrations. According to the results of the irritation screening, the concentration of 100% w/w was judged to be not irritant.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the results of an in vivo LLNA assay, performed according to the OECD guideline and GLP principles, it is concluded that Sakura Salicylate has skin sensitising properties.
- Executive summary:
The potential of Sakura Salicylate to cause skin sensitisation reactions following topical application to the skin of CBA/JN (CBA/J) mice, was assessed using the LLNA:BrdU-ELISA method, according to the OECD Guideline 442b and GLP principles.
In the main assay, the test item was topically administered at the concentrations of 100, 50 and 25% (w/w), in ethanol/diethyl phthalate 1:3 (v/v). No mortality or clinical signs were recorded in any animal. Changes in body weight observed during the study were within the expected range for this strain and age of animals. Statistically significant and dose-related increases in cell proliferation of draining lymph nodes were observed in the three treatment groups, being the calculated Stimulation Indices (SI) 1.63, 2.23 and 2.46, respectively at low, mid- and high dose levels (25%, 50% and 100% (w/w)). The results obtained in this study indicate that the test item may elicit a sensitisation response in mice following dermal exposure, since in all dose groups the Stimulation Index was greater than 1.6. The calculated EC1.6 (estimated concentration needed to produce a stimulation index of a positive response with SI≥1.6) is 22%. Based on this result, Sakura Salicylate is classified as a skin sensitiser 1B according to Regulation (EC) 1272/2008.
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