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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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to the OECD guideline No.429 (July 2010) and in compliance with the GLP guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source : Harlan Laboratories B.V., The Netherlands
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: 19.8 g (+/- 1.1 g)
- Housing: group in Makrolon Type II/III cages with wire mesh top containing granulated soft wood bedding.
- Diet (e.g. ad libitum): free access to pelleted standard diet (Harlan Laboratories B.V., The Netherlands).
- Water (e.g. ad libitum): free access to tap water.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+/- 2°C)
- Humidity (%): 30-65%
- Photoperiod (hrs dark / hrs light): 12h/12h - Concentration / amount:
- Not applicable
- Concentration / amount:
- Not applicable
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable
- Challenge controls:
- Not applicable
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- (Acetone, batch No. K40835814 (Merck, Darmstadt, Germany); Olive oil, batch No. 0001428703 (Sigma/Aldrich Chemicals, Taufkirchen, Germany))
- Concentration:
- For the preliminary test the concentrations were 50 (w/v) and 100% of the test item.
For the main test the concentrations were 0, 25, 50 (w/v) and 100% of the test item. - No. of animals per dose:
- For the preliminary test: 1 female/dose (no control): left ear and right ear were treated with 50 and 100% of the test item.
For the main test: 4 females/dose and 4 females for the negative control (total of 16 animals) - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The highest test item concentration, which could be technicallly used was 100% of the undiluted test item. The test item was soluble in the first recommended vehicle, acetone/olive oil (4/1, v/v). A solution was obtained at the maximum tested concentration of 50%.
- Irritation: Measurement of the ear thickness (using a micrometer) was performed prior to the first application (day 1), on day 3 and before sacrifice (day 6). Clinical signs and signs of local skin irritation were recorded daily. On day 4 to 6, the animals treated with 100% showed an ear erythema (score 1), in the animal treated with 50% this was only observed on day 4 of the pre-test. No signs of systemic toxicity were observed. Based on these results, the test item in the main study was assessed at 25, 50 (w/v) and 100%.
- Lymph node proliferation response: no measurement
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node cell proliferative responses were measured as described by Kimber and Dearman (1991).
- Criteria used to consider a positive response: The results were expressed as disintegration per minute (dpm) per group and per node. Stimulation indices (SI) were calculated according to the following formula: SI = dpm of treated group / dpm of control group. The test item was considered as a skin sensitizer when the SI for a dose group is higher than or equal to 3 and the data are compatible with a conventional dose response.
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was prepared in the vehicle at the chosen concentrations. All dosage form preparations were made freshly on the day of the administration and any unused material was discarded that same day. On days 1, 2 and 3, a dose-volume of 25 μL of the control or dosage form preparations was applied to the dorsal surface of both ears. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The EC3 value was calculated according to the equation:
EC3 = (a-c)[(3-d)/(b-d)]+c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; (a,b) and (c,d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I. value of 3 on the local lymph node assay dose response plot. - Positive control results:
- In the positive control group given HCA at the concentration of 25%, a stimulation index exceeding the threshold value of 3 (SI=9.03) was noted.
The study was therefore considered valid. - Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- In this study Stimulation Indices (S.I.) of 1.74, 5.39 and 9.68 were determined with the test item at concentrations of 25 and 50% (w/v) in acetone:olive oil (4 +1 v/v) and 100% (undiluted test item), respectively. A clear dose response was observed. The EC3 value calculated was 33.6%.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table below (7.4.1).
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Diisopentyl ether was found to be a skin sensitizer under the test conditions of the study.
- Executive summary:
In a local lymph node assay (LLNA) performed according to the OECD guideline No.429 and in compliance with the GLP guidelines, diisopentylether (purity 99.2%) dissolved in acetone/olive oil was assessed for its possible contact allergenic potential. The test item was administered to mice at concentrations of 25, 50% (w/v) and 100%.
The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed.
Stimulation Indices (S.I.) of 1.74, 5.39 and 9.68 were determined with the test item at concentrations of 25 and 50% (w/v) in acetone:olive oil (4 +1 v/v) and 100% (undiluted test item), respectively. A clear dose response was observed. The EC3 value calculated was 33.6%.
Reference
All treated animals survived the scheduled study period and no signs of systemic toxicity or local skin irritation were observed. The results of the main test are presented in the Table below.
Table 7.4.1: Results of the main test
Test item concentration % (w/v) |
Group |
DPM (after correction of background) |
Number of lymph nodes |
DPM per lymph node |
S.I. |
0 |
1 |
1754 |
8 |
219.2 |
1.00 |
25% |
2 |
3055 |
8 |
381.8 |
1.74 |
50% |
3 |
9450 |
8 |
1181.2 |
5.39 |
100% |
4 |
16981 |
8 |
2122.6 |
9.68 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In a local lymph node assay (LLNA) performed according to the OECD guideline No.429 and in compliance with the GLP guidelines, mice were exposed to the test substance in concentrations of 25, 50% (w/v) and 100%. The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 1.74, 5.39 and 9.68 were determined in the test item at concentrations of 25 and 50% in a blend of acetone and olive oil and 100% (undiluted test item), respectively. A clear dose reponse was observed and for this reason it was concluded that the test substance was a skin sensitizer under the test conditions.
Migrated from Short description of key information:
The test item Diisopentyl ether was found to be a skin sensitizer under the test conditions of the study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
For skin sensitisation, classification is warranted according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Cat. 2; H317). This classification translates into the classification according to EU Directive 67/548/EEC as Xi, R43 (May cause sensitisation by skin contact).
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