Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 228-408-6 | CAS number: 6259-76-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 April 1989 - 3 July 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- A category approach is proposed for hexyl salicylate using data from other salicylate substances. The members of this category are demonstrated to be metabolised rapidly by esterases to salicylic acid; systemic exposure will therefore be to the metabolites to a much greater extent. The systemic toxicity of the salicylates is comparable and is attributable to the salicylic acid generated by metabolism. The other product of metabolism is the alcohol liberated from the sidechain following esterase metabolism. In the case of hexyl salicylate, this alcohol will be 1-hexanol which is of low toxicity and is rapidly metabolised and excreted and/or incorporated into normal metabolism. Hexanol is of lower toxicity than other alcohols generated from the metabolism of other category members (e.g. methanol); the source data therefore represents a worst case approach.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1898
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Benzoic Acid, 2-Hydroxy-,2-ethylhexyl ester.
- IUPAC Name:
- Benzoic Acid, 2-Hydroxy-,2-ethylhexyl ester.
- Reference substance name:
- 2-ethylhexyl salicylate
- EC Number:
- 204-263-4
- EC Name:
- 2-ethylhexyl salicylate
- Cas Number:
- 118-60-5
- IUPAC Name:
- 2-ethylhexyl salicylate
- Reference substance name:
- HR 89/131494
- IUPAC Name:
- HR 89/131494
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): HR 89/131494
- Molecular formula (if other than submission substance): C15H22O3
- Analytical purity: 99.9%
- Lot/batch No.: 37798
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO GmbH, D-7964 Kisslegg, F.R.G.
- Age at study initiation: 6 - 10 weeks old
- Weight at study initiation: 25 - 30g
- Assigned to test groups randomly: The animals were separated according to sex, marked for identification and allocated by randomization to cages and groups.
- Fasting period before study: No information provided
- Housing: The animals were group housed, up to 5 per cage in Makrolon cages of size II with Altromin woodshavings. The cages and bedding were changed with clean ones twice a week.
- Diet (e.g. ad libitum): Standard laboratory diet (Altromin 1324) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): Approximately 55%
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark cycle.
IN-LIFE DATES: From: 21 April 1989 To: 3 July 1989
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: arachis oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The compound was dissolved in arachis oil and the solution was freshly prepared just prior to use. - Duration of treatment / exposure:
- Single exposure
- Frequency of treatment:
- The animals were dosed once
- Post exposure period:
- 72 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Vehicle control group
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Remarks:
- Treated group
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 9,10-dimethyl-1,2-benzanthracene dissolved in olive oil.
- Route of administration: oral gavage
- Doses / concentrations: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow polychromatic erythrocytes (PCEs)
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES
The test animals were killed by cervical dislocation and bone marrow removed from both femora by rinsing with fetal calf serum. Bone marrow cells were centrifuged at 150g for 10 minutes and the supernatant discarded. From the pellet, smears were made on slides and air dired, according to haematological routine.
DETAILS OF SLIDE PREPARATION:
2 slides were made per animal. The preparations were stained by the May-Gruenwald-Giemsa method according to Schmid (1973). The slides were stained for 3 minutes in undiluted May-Gruenwald solution. They were then stained for 2 minutes in May-Gruenwald, diluted with distilled in a 1:1 ratio followed by brief rinsing in distilled water. The slides were stained for 10 minutes in Giemsa, diluted with distilled in a ratio of 1:6 and rinsed thoroughly in distilled water. They were dried in air and the back of the slides was dried with methanol. They were cleared in Xylene for 5 minutes and mounted in Eukitt.
METHOD OF ANALYSIS:
The slides were coded and observed blindly under a microscope with a 100x oil immersion objective lens at 1250 fold magnification. At least 1000 polychromatic erythrocytes per animal were scored for the incidence of micronuclei. The number of micronucleated normochromatic erythrocytes was also recorded. The ratio of polychromatic to normochromatic erythrocytes was determined for each animal by counting a total of 1000 erythrocytes.
Statistical significance was determined according to the methods of Kastenbaum and Bowman (1970). - Evaluation criteria:
- No information provided
- Statistics:
- Statistical significance was determined according to the methods of Kastenbaum and Bowman (1970).
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: According to an initial toxicity test, the maximum tolerated dose was fixed to 2000 mg/kg body weight.
RESULTS OF DEFINITIVE STUDY
- Ratio of PCE/NCE (for Micronucleus assay): No increase in the frequency of micronucleated polychromatic erythrocytes in any treatment group at any treatment time. The incidence of micronucleated normochromatic erythrocytes in all treatment groups was within expected levels. The ratio of polychromatic erythrocytes to normochromatic erythrocytes was considered to be normal.
Afte dosing, the animals of all treated groups showed reduced motility.
Any other information on results incl. tables
No additional information
Applicant's summary and conclusion
- Conclusions:
- No evidence of micronucleus formation was seen under the conditions of this assay.
- Executive summary:
The genetic toxicity of 2 -ethylhexyl salicylate was investigated in a mouse bone marrow micronucleus assay. Groups of five male and five female mice were treated by single oral administration of 2 -ethylhexyl salicylate (in arachis oil) at the limit dose level of 2000 mg/kg bw. The animals were sacrificed and bone marrow smears were prepared at 24, 48 and 72 hours after treatment. A positive (DMBA) and negative (vehicle) control group were also tested. At least 1000 polychromatic erythrocytes (PCEs) from each animal were scored for the incidence of micronuclei. The number of micronucleated normochromatic erythrocytes (NCEs) was also recorded, and the PCE:NCE ratio determined for each animal by counting a total of 1000 erythrocytes. No evidence of micronucleus formation was seen under the conditions of this assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)