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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-377-9 | CAS number: 94-96-2
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data obtained from a publication in a peer-reviewed journal
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Repeated exposure toxicity of 2-ethyl-1,3-hexanediol by cutaneous applications to the rat for 9 and 90 days.
- Author:
- Van Miller JP, Losco PE, Neptun DA, Ballantyne B.
- Year:
- 1 995
- Bibliographic source:
- Vet Hum Toxicol. 37(1): 33-36
- Reference Type:
- publication
- Title:
- Toxicology Update 2-Ethyl-1,3-hexanediol
- Author:
- Ballantyne B
- Year:
- 2 005
- Bibliographic source:
- J. Appl. Toxicol 25: 248-259
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylhexane-1,3-diol
- EC Number:
- 202-377-9
- EC Name:
- 2-ethylhexane-1,3-diol
- Cas Number:
- 94-96-2
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2-ethylhexane-1,3-diol
- Test material form:
- liquid: viscous
- Details on test material:
- 98.9% purity.
Impurities were two isomers of monbutyrate ester of EHD.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on exposure:
- Dosages were 0.5, 2.0 and 4.0 ml/kg (equivalent to 471, 1884 and 3768 mg/kg) applied occlusively for 6 h per day. Controls received 2.0 ml/kg distilled water, also applied for 6 h/day. Applications of EHD and distilled water were made for five days/week for 13 weeks (65 applications to the skin over 91 days).
- Duration of treatment / exposure:
- 13 weeks, 5 days per week
- Frequency of treatment:
- daily, 6 h per day under occlusive patch
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
3768 mg/kg bw/d
Basis:
- Remarks:
- Doses / Concentrations:
1884 mg/kg bw/d
Basis:
- Remarks:
- Doses / Concentrations:
471 mg/kg bw/d
Basis:
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- An additional 5 animals per sex were added to the high dose EHD and water control groups and sacrificed 6 weeks after the final skin application (recovery group).
Examinations
- Observations and examinations performed and frequency:
- Monitors for toxicity were clinical signs, body weights, food consumption, hematology (erythrocyte count, hemoglobin concentration, packed cell volume (PCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), platelet count, total and differential white cell count), clinical chemistry (aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, gamma-glutamyl transferase (ɣ-GT), creatine phosphokinase (CPK), lactate and sorbitol dehydrogenases, glucose, total protein, albumin, globulin, bilirubin, creatine, urea nitrogen, phosphorus, Ca2+, Na+, K+ and Cl−), urinalysis (volume, specific gravity, pH, microscopy, blood, protein, ketones, glucose, bilirubin and urobilinogen), organ weights and gross and microscopic pathology.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased body weight gain in males at week 2 and in females during interim weeks and 1 week during recovery.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased during interim weeks; no difference after a 6 week recovery.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Increased liver weight in high-dose males
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- At the high dose there were interim body weight changes. Body weight gain was slightly but statistically significantly reduced the high-dose males at week 2, and with females for weeks 3–10 and 18 (9–18% reduction). At the end of the dosing period the difference in weight gain was 8%. At the end of the recovery period there were no differences in body weight gain between treatment and control groups. A statistically significant reduction in food consumption occurred for weeks 3, 4 and 6–12 with high-dose female rats, for weeks 3 and 7 for mid-dose females, and for weeks 3, 4, 6, 7 and 9 with low-dose females, but no differences were recorded during the recovery period with high-dose females. Relative liver weight was increased slightly (4%) in high-dose males (3.160 ± 0.147% versus 3.020 ±0.079%; P < 0.05) at the end of the dosing period; this resolved during the recovery period. The slight increases in relative liver weight were not accompanied by any biochemical or cytological evidence of liver injury.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 884 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- 2-Ethylhexane-1,3-diol (EHD) at doses of 0.5, 2.0, and 4.0 ml/kg bw/d were applied daily under occlusive bandages to Fisher 344 rats for 13 weeks, with some rats continuing for 6 weeks in a recovery protocol. The rats were assessed for signs of toxicity and growth impairment. No deaths or signs of significant toxicity occurred. There was decreased body weight gains in high-dose females and increased relative liver weight without histopathology in high dose males. The NOAEL is the mid-dose of 2.0 ml/kg bw/d or 1884 mg/kg bw/d.
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.