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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
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EC number: 931-740-0 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1992-03-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Repeated-dose dermal toxicity, similar to that of OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), studies performed with the only identified and quantified constituent of the registered substance, 2-ethylhexanol. Studies performed with pregnant Fischer F344 rats and they study the developmental toxicity of 2-ethylhexanol. In the absence of the registered substance these studies serve as a good surrogate studies: a) it represents the effects of the only identified and quantified constituent of the substance, since the constituents of this registered UVCB-substance cannot be quantified and its composition varies to the degree that composition cannot be fixed. b) studies have been performed with good quality and data is published in a peer-reviewed journal. c) they provide adequate information on effect levels of 2-ethylhexanol when administered via dermal route.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD TG422: dermal route
- Deviations:
- yes
- Principles of method if other than guideline:
- Pregnant Fischer 344 rats were studied in two studies with an occluded dermal application:
1. Range-finding study
2. Main study - GLP compliance:
- yes
- Remarks:
- U.S EPA Health effects guidelines and Good Laboratory Practice regulations.
Test material
- Reference substance name:
- 2-ethylhexan-1-ol
- EC Number:
- 203-234-3
- EC Name:
- 2-ethylhexan-1-ol
- Cas Number:
- 104-76-7
- Molecular formula:
- C8H18O
- Details on test material:
- Surrogate material: 2-ethylhexanol.
Test substance - 2-ethylhexanol: 99,72% purity, gas chromatographic verification by the contract laboratory. (sample provided by the Shell developmental company, Houston, TX, USA). Gas chromatographic: at the beginning of the studies and in the end of the studies. Test material was verified to be stable over the treatment periods.
Control substances: 2-methoxyethanol (dermal reference) and valproic acid (cavage reference) had purities of 99,9% and 98,0%, respectively.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Virgin F344 rats (CDF(R) F344 Crl./Br.)
- Source: Charles River Breeding Laboratories (Kingston, NY)
- Age at study initiation: 70 days / 63 days
- Weight at study initiation: males 175-200g / females 130-150g
- Gestational day 0: appearance of copulatory plug
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2-week quarantine period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 42-65
- Air changes (per hr): not disclosed
- Photoperiod (hrs dark / hrs light): 12 hour
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: positive control for adverse effects on reproduction: 2-methoxyethanol
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
1.Rangefinding study: 0.5, 1, 2, 3 (ml/kg/day) equivalent to 420, 840, 1680, 2520 (mg/kg/day). Positive control: 2-methoxyethanol: 0.5 and 1.5 (ml/kg/day) equivalent to 420 and 1260 (mg/kg/day). Oral cavage reference compound: Valproic acid 400 mg/kg bw/day.
2. Main study: 0.3, 1, 3 (ml/kg/day) equivalent to 252, 840, 2520 (mg/kg/day).Positive control: 2-methoxyethanol 1 (ml/kg/day) equivalent to 840 (mg/kg/day)
- Concentration (if solution): 100%
- Constant volume or concentration used: no
VEHICLE
- No vehicle - Duration of treatment / exposure:
- 6-hours day
- Observation period:
- Before and after treatment
- Number of animals:
- Range-finding study: 8 animals per group
Main study: 25 animals per group - Details on study design:
- TEST SITE
- Area of exposure: clipped and shaved dorsal skin of 9,7 cm2 (in the report ca. 1,5 cupic inches)
- Type of wrap if used:2 cupic inch gauze square, occluded with a Lycra-Spandex with Velcro closures. A 1.5x2.5 in. polyethylene patch was attached at the application site under the jacket.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped gently with moist gauze and blotted dry.
- Time after start of exposure: 6-hours
SCORING SYSTEM:
Draize score, FHSA (1987)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- Draize score
- Time point:
- other: before and after 6-hour treatment
- Score:
- < 1.1
- Max. score:
- 1.1
- Reversibility:
- fully reversible within: 18 hours
- Remarks on result:
- other: effects occurred during treatment and were transient or ameliorated after treatment ceased
- Irritant / corrosive response data:
- DERMAL IRRITATION
Treatment -related effects attributable to 2-ethylhexanol at the application site were exfoliation, encrustation and erythema. There was no edema. Exfoliation and encrustation occurred in both range-finding and main studies at all treatment levels of 2-ethylhexanol. There was no erythema or edema in sham controls. Erythema occurred during treatment with 2-ethylhexanol at levels of 830 mg/kg bw/day and above. Draize scores revealed that irritation was essentially mild. Maximum mean treatment scores occurred on gd10 at 1680 mg/kg bw/day (draize-score 0.4, range-finding study), on gd 11 at 2520 mg/kg bw/day (draize-score 1.1, range-finding study), and on gd 14 at 1680 mg/kg bw/day (draize-score 0.3, main study).
There was no exacerbation by continuent treatment. Erythema subsided immediately after cessation of treatment. There was no exfoliation, encrustation, erythema or edema at the application of control, 2-methoxyethanol.
Nasal encrustation and ocula encrustation and discharge were seen mostly in the main study with 2-ethylhexanol and 2-methoxyethanol and in sham controls. Since these effects occurred in controls and mostly disappeared after treatment ceased they are attributed to handling stress. - Other effects:
- Weight reduction at highest concentrations (1680 and 2520 mg/kg bw/day).
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Repeated dermal exposure of 2-ethylhexanol lead with high doses (1680 and 2520 mg/kg bw/day) to slight reduction in body weight, otherwise it did not indicate properties which would lead to a concern for toxicity via dermal route. There was no exacerbation by continuent treatment. Erythema subsided after cessation of treatment. The only effect was mild skin irritation.
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