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EC number: 204-265-5 | CAS number: 118-61-6
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Closed Epicutaneous Test
- Author:
- M. ISHIHARA et al.
- Year:
- 1 986
- Bibliographic source:
- Hifu 28: 230–240
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (not referenced in the publication)
- Deviations:
- yes
- Remarks:
- see ´principles of method if other than guideline´
- Principles of method if other than guideline:
- Relevant deviations from OECD TG 406:
- 10 animals used i.s.o. 20 as prescribed for non-sensitizing substances
- Inducton concentraton = 30% = highest non-irritant conc. i.s.o. conc. that exerts mild to moderate irritation
- Multple inductons: 6 times over 2 weeks, i.s.o. single induction
Limited information on results, only tabulated outcome per substance, no individual findings available. - GLP compliance:
- not specified
- Type of study:
- other: closed epicutaneous test
- Justification for non-LLNA method:
- The REACH Annex VII information requirements were revised in 2016 to endorse a battery of in vitro assays for skin sensitisation. The in vivo closed epicutaneous test was conducted prior to the validation and regulatory acceptance of alternative methods.
Test material
- Reference substance name:
- Ethyl salicylate
- EC Number:
- 204-265-5
- EC Name:
- Ethyl salicylate
- Cas Number:
- 118-61-6
- Molecular formula:
- C9H10O3
- IUPAC Name:
- ethyl 2-hydroxybenzoate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Test animals:
Female albino Hartley guinea pigs (Shizuoka Agricultural Cooperative Association for Laboratory Animals), 300 – 350 g body weight
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 30%
- Day(s)/duration:
- 48 H, 3 times a week for 2 weeks
- Adequacy of induction:
- other: maximum non-irritative concentration
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 48 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 – 20 guinea pigs per group
- Details on study design:
- Preparation of the test animals:
Both flanks are clipped using an electric clipper and shaved using an electric shaver
The nape area of 2.5 cm quartet is clipped and shaved
Application of the test material (induction):
- 20 mg of test material (base material: white petrolatum) at 6 concentrations (30 – 0.1%) is smeared to Finn Chamber (EpitestFinn Chamber on Scanpol Tape) and placed on both flanks
- Two strips of adhesive tape, approximate 5 cm width and approximate 40cm length, are wrapped around the animal completely covering the Finn chamber
- A Reston foam pad, approximate 1.5 cm width, 6 cm length and 1cm thickness, is placed over the Finn chambers
- Reston foam pad is fixed with a strip of adhesive tape, approximate 7.5 cm width and approximate 40 cm length, and then Reston foam pad is fixed again with two strips of adhesive tape, approximate 5 cm width and approximate 40 cm length
- Closed application is continued for 48 hours, and irritation response is judged at 1, 24 and 48 hours after removal of test material.
- Above procedures are repeated totally 6 times, 3 times per week (on Monday, Wednesday and Friday) for 2 weeks.
Application of the test material (challenge):
- After 2-week withdrawal period, closed application of test material is performed on both flanks at several concentrations below the irritation concentration for 2 days for challenging similarly as in irritation test
- Approximate 50 mg of the test material at the minimum irritation concentration or maximum non-irritation concentration is spread homogeneously on the cloth of patch plaster and then the patch is applied on the nape
- Adhesive tape, approximate 2.5 cm width and approximate 30cm length, is wrapped around the nape to secure the patch plaster
- Approximate 2.0 cm quartet Reston foam pad is placed on the patch plaster
- Reston foam pad is fixed with a single strip of adhesive tape, approximate 2.5 cm width and approximate 30 cm length - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: summary
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% (induction) / 1% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present Closed Epicutaneous Test (CET) the test substance was not sensitizing
- Executive summary:
A Closed Epicutaneous Test (CET) was performed on 10 to 20 female guinea pigs to determine the sensitizing potential of the test substance in petrolatum.
The test was not performed according to a guideline but resembles the OECD TG 406 and it was not performed according to GLP.
The method description is rather detailed, with some details missing. The information on the results is limited and no individual findings are available.
In the induction phase of the Closed Epicutaneous Test. (CET), the test material was applied occluded for 48 hours at the highest non-irritative concentration (30%) on the shaved nape and this procedure is repeated three times per week for two weeks.
FoIlowing a two-week rest period, the test material is applied at the maximum non-irritative concentration (1%) under occlusion for 48 hours on the flanks for chaIlenge.
This resulted in no indication of sensitization (rate: 0/10).
In the present Closed Epicutaneous Test (CET) the test substance was not sensitizing
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