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EC number: 208-857-4 | CAS number: 544-01-4
- 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
Endpoint summary
Administrative data
Description of key information
The substance showed no acute oral toxicity in female rats with an LD50 of > 2000 mg/kg bw. In an acute inhalation study, the LC50 was determined at 2-10 mg/L for male and female rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier (53940 Le Genest St Isle - France)
- Age at study initiation: 8 weeks old
- Weight at study initiation: 191 - 205 g
- Housing: group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid containing sawdust bedding
- Diet (e.g. ad libitum): free access to standard diet (M20, SDS).
- Water (e.g. ad libitum): free access to tap water.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h
- Air changes (per hr): approx. 15 changes per hour - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test item was administered as supplied by gavage under a volume of 2.57 mL/kg body weight (corresponding to 2 g/kg bw, according to the calculated density).
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- six females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for a period of 14 days to identify any behavioural or toxic effects. The rats were weighed on day 0 (just before administering the test item) and at 2, 7 and 14 days after dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Preliminary study:
- Not applicable
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test item were observed.
- Gross pathology:
- Macroscopical examination of the animals at the end of the study did not reveal treatment related changes.
- Other findings:
- Not applicable.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of diisopentyl ether is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered as 5000 mg/kg body weight by oral route in the rat.
- Executive summary:
In a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, the test item diisopenyl ether was administered to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight.
No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normaly throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related changes.
In conclusion, the LD50 of diisopentyl ether is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered as 5000 mg/kg body weight by oral route in the rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 12 weeks old
- Weight at study initiation: 197-225 (females); 331-371 (males)
- Housing: group housing of 5 aminals per sex per cage in Makrolon cages (type IV; height 18 cm) containing sterilised sawdust as bedding material (Litalabo, France) and paper as cage-enrichment.
- Diet (e.g. ad libitum): free access to pelleted rodent diet (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): free access to tap water.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12h/12h
- Air changes (per hr): approx. 15 changes per hour - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose-only exposure units. The chamber consisted of three animal sections with eight animal ports each. Each animal port had its own atmosphere inlet and exhaust outlet.
- Method of holding animals in test chamber: plastic animal holders, positioned radially through the outer cylinder around the central column
- Source of air: compressed air
- System of generating particulates/aerosols: a vapor was generated by nebulization of the test substance. For 2 mg/L, a LC SPRINT STAR nebulizer (Pari, Starnberg, Germany) was used, dried pressurized air was used for dilution (main total airflow 21 L/min). For 10 mg/L, a type 950 nebulizer (Hospitak Inc., Lindenhurst, NY, USA) was used, humidified pressurized air was used for dilution (mean total airflow 19 L/min.).
- Method of particle size determination: Not applicable.
- Treatment of exhaust air: exhaust air is passed through a filter before it was released to the exhaust of the fume hood.
- Temperature, humidity, pressure in air chamber: 21-22°C; 16-18% (exposure to 2 mg/L) and 49-50% (exposure to 10 mg/L).
TEST ATMOSPHERE
- Brief description of analytical method used: The actual concentration was determined continuously during each exposure. A small stream of the test atmosphere was drawn through a tube mounted in one of the free animal ports. The tube was heated to avoid condensation of the test atmosphere. The tube was connected to a gas cell which was mounted in a FTIR spectrophotometer. The mean values and the SD were calculated.
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Target: 2 and 10 mg/L
Nominal: 1.8 and 6.7 mg/L
Analytical: 1.9 (± 0.15), 7.1 (± 1.8)
Remark: Due to a technical failure of the FTIR, the exposure was interrupted for approx. 20 minutes. The generation time was elongated to compensate for this interruption and to achieve an actual exposure time of 4 hours. Following this interruption, it was technically not possible to meet the target concentration of 10 mg/L. - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Frequency of observations and weighing: The animals were inspected twice daily for mortality throughout the test. During exposure, the animals were observed three times for mortality, behavioural signs of distress and effects on respiration. After exposure, animals were checked one and three hours after exposure and once daily thereafter until Day 15. The body weight of each animal was recorded on Days 1 ( just prior to exposure), 2, 4, 8 and 15 and at death (if found dead or sacrificed after Day 1).
- Necropsy of survivors performed: Yes. Particular attention was given to any changes in the respiratory tract. - Preliminary study:
- Not applicable.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1.9 - 7.1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- At 2 mg/L, no mortality occurred. At 7 mg/L, one male was found dead and the remaining two males were sacrificed for human reasons on Day 1 post-exposure. Two females were found dead on Day 2 and one female survived the observation period of 14 days.
- Clinical signs:
- other: At 2 mg/L, no clinical signs were noted during and after exposure. At 7 mg/L, slow breathing was noted in two males and one female during exposure. After exposure, hunched posture, laboured respiration and piloerection were seen in all animals on Day 1.
- Body weight:
- Overall body weight gain in males and females exposed to 2 mg/L was within the range expected for rats of this strain and age used in this type of study. Body weight loss was seen in the surviving female of the study period following exposure to 7 mg/L.
- Gross pathology:
- Macroscopic post mortem examination of the animals that were found dead or sacrificed for ethical reasons during the study revealed abnormalities at the lungs (dark red discolouration). No abnormalities were found at macroscopic examination of the surviving animals.
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The inhalatory LC50 (4 h) value of diisopentyl ether in Wistar rats was established to be within the range of 1.9 and 7.1 mg/L. Based on these results, the inhalatory LC50 (4h) value of diisopentyl ether in Wistar rats was considered to fall within the range of 2 - 10 mg/L.
- Executive summary:
In a GLP compliant study, performed according to OECD guideline 436, the acute inhalation toxicity of Diisopentyl ether was investigated. Diisopentyl ether was administered as a vapor by inhalation for 4 hours to two groups of three male and three female Wistar rats. At 2 mg/L, no mortality occurred. At 7 mg/L, one male was found dead and the remaining two males were sacrificed for human reasons on Day 1 post-exposure. Two females were found dead on Day 2 and one female survived the observation period of 14 days. The inhalatory LC50 (4 h) value of diisopentyl ether in Wistar rats was established to be within the range of 1.9 and 7.1 mg/L. Based on these results, the inhalatory LC50 (4h) value of diisopentyl ether in Wistar rats was considered to fall within the range of 2 - 10 mg/L.
Reference
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 7 000 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral route
In a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, 6 female rats were exposed to 2000 mg/kg bw of Diisopentyl ether (Phycher, 2011). No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normaly throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related changes. In conclusion, the LD50 of diisopentyl ether is higher than 2000 mg/kg body weight by oral route in the rat.
Inhalation route
In an acute inhalation study performed according to OECD guideline 436 and GLP guidelines, diisopentyl ether was administered as a vapor by inhalation for 4 hours to two groups of three male and three female Wistar rats. Animals were observed daily and body weight measurements were taken on Days 1, 2, 4, 8 and 15. Macroscopic examination was performed on the day of death or after terminal sacrifice (day 15).
At 2 mg/L, no mortality occurred. At 7 mg/L, one male was found dead and the remaining two males were sacrificed for human reasons on Day 1 post-exposure. Two females were found dead on Day 2 and one female survived the observation period of 14 days. Based on these results, the inhalatory LC50 (4h) value of diisopentyl ether in Wistar rats was considered to fall within the range of 2 - 10 mg/L.
Dermal route In accordance with column 2 of REACH Annex VIII-IX, as acute toxicity studies for the oral and inhalation route are available, no study regarding the dermal route is needed.
Justification for classification or non-classification
As no mortality was observed after administration of a single dose of 2000 mg/kg bw, Diisopentyl ether does not have to be classified for acute oral toxicity.
According to Directive 67/48/EEC, Diisopentyl ether has to be classified as Xn; R20 (Harmful if inhaled) based on the acute inhalation LC50 value of 2 - 10 mg/L. Based on the same data, the substance has to be classified for Acute toxicity, Cat. 3, via inhalation route (H331, Toxic if inhaled) according to the EU Classification, Labeling and Packaging of Substance and Mixtures (CLP) Regulation (EC) No. 1272/2008
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