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EC number: 244-815-1 | CAS number: 22174-70-5
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 04-21, 2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3,3'-[methylenebis(oxymethylene)]bisheptane
- EC Number:
- 244-815-1
- EC Name:
- 3,3'-[methylenebis(oxymethylene)]bisheptane
- Cas Number:
- 22174-70-5
- Molecular formula:
- C17H36O2
- IUPAC Name:
- 3,3'-[methylenebis(oxymethylene)]diheptane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-ethylhexylal
- Analytical purity: 99.766%
- Impurities (identity and concentrations): 2-Ethylhexanol (0.0826 %), Formaldehyde (not found), Water (0.0370 %)
- Lot/batch No.: 1204051500
- Expiration date of the lot/batch: 3 years / 05.04.2015
- Storage condition of test material: Store in supplied bottle in dark at the temperature under 25°C. Provide local exhaust or general room ventilation. Keep container closed when not in use. Keep away from heat.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Age at study initiation: not specified
- Weight at study initiation: average of 254.72 kg for males; average of 2175.75 kg for females
- Fasting period before study: not specified
- Housing: animal room with monitored conditions – one animal in one plastic cage
- Diet (e.g. ad libitum): ST 1 BERGMAN – standard pelleted diet ad libitum (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy).
- Water (e.g. ad libitum): drinking tap water ad libitum (quality corresponding to the Regulation No. 252/2004 of Czech Coll. of Law)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22 + 3 °C, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Preparation of experimental animals
Approximately 24 hours before application, a skin area of about 6 x 6 cm on the back of animals was shaved (aprox. 10% of the body surface). The animals were weighed immediately before application.
Preparation and application of the test substance
The amount of test substance for each animal was weighed out (according to its body weight and the dose) immediately before application.
The test substance in delivered form was applied on the depilated area of skin. The application site was covered by mull and held in contact by plaster (strapping). After 24 hours the semiocclusive dressing was removed, and remains of the test substance were wiped off with water. - Duration of exposure:
- 24 hours
- Doses:
- The study was performed as limit test: two groups of animals – 5 males and 5 females and the dose of 2000 mg/kg. The pre-test was performed with 1 male and 1 female of the groups of the five animals. The pre-test was started one day before the start of limit test.
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight recording
The animals were weighed at the start of the study (before application), at 8th day and at the end of experiment (15th day). The average body weight of the groups was calculated from individual body weights. Body weight increments were calculated from the body weight at the start of the study, during the first week and at the end of the study.
Clinical observation
After application the animals were observed individually – at the first day: twice (30 minutes and 3 hours after application), at the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days. Observations included changes in skin and fur, eyes, visible mucous membranes, nutritive
condition, autonomic and central nervous systems, psychic activity, somatomotor activity, reactions to stimuli, function of respiratory, circulatory, digestive and urogenital system. Also presence of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma was carefully observed.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
All test animals survived to the end of study were sacrificed on the 15th day by injection of
veterinary preparation T61 (1 ml iv.) and gross necropsy was carried out. Nutritious status,
body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross
macroscopic changes of organs and tissues were recorded on special data sheets. - Statistics:
- Not necessary
Results and discussion
- Preliminary study:
- For male:
no death
30 minutes: no clinical signs of intoxication
3 hours: no clinical signs of intoxication
2nd – 14th day: no clinical signs of intoxication
For female:
no death
30 minutes: no clinical signs of intoxication
3 hours: no clinical signs of intoxication
2nd – 14th day: no clinical signs of intoxication
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was recorded
- Clinical signs:
- other: No clinical signs of intoxication were detected after application in all animals
- Gross pathology:
- No macroscopic changes were diagnosed during pathological examination in all animals
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance toxicity was evaluated on the basis of mortality, body weight changes, and clinical signs of toxicity during the observation period and necropsy findings at the end of study.
The test substance applied on skin at a dose of 2000 mg/kg of animal weight did not cause death of animals.
No clinical signs of intoxication were observed. No macroscopic changes were diagnosed during pathological examination of animals.
According to the results of study, the value of LD50 (dermal) of the test substance, 2-ETHYLHEXYLAL, is higher than 2000 mg/kg of body weight for rats of both sexes. - Executive summary:
Acute dermal toxicity of 2 -ethylhexylal was evaluated in an in vivo test performed according to OECD TG 402 (limit test).
The test substance toxicity was evaluated on the basis of mortality, body weight changes, and clinical signs of toxicity during the observation period and necropsy findings at the end of study. The test substance applied on skin at a dose of 2000 mg/kg of animal weight did not cause death of animals. No clinical signs of intoxication were observed. No macroscopic changes were diagnosed during pathological examination of animals. According to the results of study, the value of LD50 (dermal) of the test substance, 2-ETHYLHEXYLAL, is higher than 2000 mg/kg of body weight for rats of both sexes.
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