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EC number: 204-317-7 | CAS number: 119-36-8
- 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:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methyl salicylate
- EC Number:
- 204-317-7
- EC Name:
- Methyl salicylate
- Cas Number:
- 119-36-8
- Molecular formula:
- C8H8O3
- IUPAC Name:
- methyl salicylate
- Details on test material:
- - Name of test material (as cited in study report): HR 99/130785, CAS 119-36-8
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Moellegaard Breeding & Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.2-2.4 kg
- Housing: individually in PPO cages with perforated floor.
- Diet (e.g. ad libitum): Altormin 2123 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 May 1999 To: 1 June 1999
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: closely clipped
- Vehicle:
- other: unchanged and diluted with ethanol/diethyl phthalate 1:1
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml (total volume including vehicle when diluted)
- Concentration (if solution): 1, 5, 10, 25, 100%
VEHICLE
- Amount(s) applied (volume or weight with unit): see above
- Concentration (if solution): 0, 75, 90, 95, 99%
- Lot/batch no. (if required): no data
- Purity: no data - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm per test site
- % coverage: no data
- Type of wrap if used: Gothaplast tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): mild soap and lukewarm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Standard OECD 404 scoring method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 1.67
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: For undiluted test substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 0.67
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: for undiluted test substance
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: for 25% solution of test substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reactions
- Remarks on result:
- other: for 25% solution of test substance
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reactions
- Remarks on result:
- other: for 1, 5 or 10% solution of test substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reactions
- Remarks on result:
- other: for 1, 5, 10% solution of test substance
- Irritant / corrosive response data:
- For the undiluted test substance, animals showed from very slight to well-defined erythema and/or oedema from the 1-hour to the 72-hour observations. At the 7-day observation all animals showed small white scales on the test site. these had resolved by the 14-day observation.
For the 25% solution, only very slight erythema was noted in one animal at the 24- and 48-hour observations.
No reactions were noted for the lower test concentrations. - Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- MeS was slightly irritating to rabbits but does not require classification according to the criteria of EU DSD or CLP.
- Executive summary:
The primary skin irritation of HR 99/130785 (methyl salicylate) was investigated according to the method recommended in the OECD Guideline No. 404 and EEC Guideline B.4. Four female albino rabbits were exposed to the test article and the vehicle at two skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined at 1, 24, 48 and 72 hours, as well as 7 and 14 days after the termination of exposure. Slight to well-defined skin reactions were observed. The mean scores reported were: undiluted MeS: 1.3 for erythema and 0.6 for oedema; 25% solution: 0.2 for erythema and 0.0 for oedema. No reactions were reported for 1, 5 or 10% solutions. According to directive 93/21/EEC, the test substance should not be classified as irritating to the skin.
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