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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 23, 1990 to March 15, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline test with GLP, well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals and Animal Husbandry
Nine male and nine female Sprague-Dawley strain rats were supplied by Bantin & Kingman Ltd., Aldborough, Hull, U.K. At the start of the main study the males weighed 129 - 148g, and the females 120 - 154g, and were approximately five to eight weeks old. After a minimum acclimatisation period of five days the animals were selected at random and given a unique number within the study by ear punching and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1 Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
Animals and Animal Husbandry (contd)
The animal room was maintained at a temperature of 21 - 23 °C and relative humidity of 39 - 55%. On one occasion the relative humidity was outside the lower limit specified in the protocol (40%). This did not affect the purpose or integrity of the study. The rate of air exchange was approxi- mately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- a single dose: 5000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- a) Range-finding Study
In order to establish a suitable dose level for the main study groups of two rats (one male and one female) were treated once only at levels of 5000, 3000, 1000 and 500 mg/kg. Animals were observed 1 and 4 hours after dosing and then daily for five days.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.
b) Main Study
A group of ten rats (five males and five females) was dosed as follows in order to confirm the findings of the range-finding study.
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation.
Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14 or at death. - Statistics:
- no data
Results and discussion
- Preliminary study:
- No mortality was observed in the range finding study at doses of 500, 1000, 3000 and 5000 mg/kg bw (observation period 5 days). Using the mortaiity data given above the oral LD50 of the test materiai was considered to be greater than 5000 mg/kg bodyweight. This dose level was therefore used for the main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No evidence of toxicity related to test article was observed.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No evidence of systemic toxicity or skin irritation was noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy of animals killed at the end of the study.
- Other findings:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (oral, rat): >5000 mg/kg
- Executive summary:
This acute study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered undiluted in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity". Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material preparation at a dose level of 5000 mg/kg bodyweight. There were no deaths. No evidence of systemic toxicity or skin irritation was noted during the study. No toxicologically significant effects on bodyweight gain were noted during the study period. No abnormal ties were noted at necropsy of animals killed at the end of the study.
Therefore, the acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat, was found to be greater than 5000 mg/kg bodyweight under the condition of this study.
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