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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-870-1 | CAS number: 111-44-4
- 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
1. Skin sensitisation:
No information is available in the literature regarding the skin sensitisation potential of Bis(2-chloroethyl) ether. An in vivo study was conducted in 2015, i.e before the amended Reach Annexe VII entered into force the 11th October 2016. The aim of this study was to determine the skin sensitisation potential of Bis(2-chloroethyl) ether following dermal exposure. The study was performed according to OECD Test Guideline No. 429 and EC No 440/2008 Guideline B.42 (reliability 1). The test item was formulated in acetone:olive oil 4:1 (v:v) mixture (abbreviated as AOO). The test item solutions were applied on the dorsal surface of ears of experimental animals (25 μL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI). No mortality or signs of systemic toxicity were observed during the study. No treatment related effects were observed on the mean body weight changes. The stimulation index values were 1.1, 1.0 and 1.3 at concentrations of 50, 25 and 10 % (w/v), respectively. The result of the positive control substance α-Hexylcinnamaldehyde (HCA) showed a significant lymphoproliferative response (stimulation index value of 8.6), which confirmed the validity of the assay. Under the conditions of the present assay Bis(2-chloroethyl) ether, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
1. Respiratory sensitisation:
No study is available regarding the respiratory sensitisation potential of Bis(2-chloroethyl) ether. In addition, information regarding this endpoint is not required according to Annex VIII of Regulation EC No. 1907/2006.
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:
- From 02-oct-2015 to 18-mar-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- temperature range was 18.0-25.9 °C instead of 22 ± 3 °C and the actual relative humidity range was 31-72 % instead of 30-70 %
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- TEST MATERIAL
- Name (as cited): 2,2`- Dichlorodiethyl ether
- Purity: 99.76%
SOURCE OF TEST MATERIAL
- Batch No.: 20150706
- Expiration date of the lot/batch: 01 June 2016
- Purity test date: 28 August 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%), protected from light - Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories S.r.l.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks old (age-matched, within one week)
- Weight at study initiation: 20.0-21.7g (The weight variation in animals in the study did not exceed ± 20 % of the mean weight)
- Housing: Group caging / mice were provided with glass tunnel-tubes
- Diet: ssniff® SM Rat/Mouse ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0 – 25.9 °C
- Humidity (%): 31 - 72 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary Irritation/Toxicity Test:
Item concentrations were 100 % (undiluted) and 50 % (w/v) in AOO
Main Test:
Item concentrations were 50, 25 and 10 % (w/v) in AOO - No. of animals per dose:
- Preliminary Irritation/Toxicity Test: 2 animals/dose
Main Test: 4 animals/dose - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: 10.6 g/L in water at 25°C
- Irritation: No irritation
- Systemic toxicity: Both animals in the 100 % (undiluted) dose group were found dead on Day 2. Animals in the 50% dose group were symptom-free.
- Ear thickness measurements: No change at day 3
- Erythema scores: ES score = 0
MAIN STUDY
No mortality or signs of systemic toxicity. No indications of any irritancy at the site of application. No treatment related effects on the mean body weight changes. Body weight loss of 5.1% was observed for one animal (No. 13) in the 10 % (w/v) dose group but this was considered as animal variability and not related to test item.
ANIMAL ASSIGNMENT AND TREATMENT
- Animal assignment: The animals were randomised and allocated to the experimental groups. The randomisation was checked by computer software using the body weight to verify the homogeneity and variability between the groups.
- Criteria used to consider a positive response: Stimulation index
TREATMENT PREPARATION AND ADMINISTRATION:
- Justification of dose selection: The maximum concentration of test item in an acceptable solvent was established according to OECD guideline 429 and was found to be 100 % (undiluted). During the Preliminary Irritation / Toxicity Test mortality was observed. Both animals in the 100 % (undiluted) dose group were found dead on Day 2. The 50 % (w/v) dose was selected as top dose for the main test as no mortality occur, no marked body weight loss (>5%) and no increased ear thickness values were detected, and draining auricular lymph nodes were normal at this dose. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- No mortality or signs of toxicity were observed. A significant lymphoproliferative response (stimulation index value of 8.6) was noted. The DPN values observed for the vehicle and positive control substance in this experiment were within the historical control range.
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 50% (w/v) in AOO
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 25% (w/v) i n AOO
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 10% (w/v) in AOO
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS
No mortality or signs of systemic toxicity were observed during the main study. There were no indications of any irritancy at the site of application.
BODY WEIGHTS
No treatment related effects were observed on the mean body weight changes. Body weight loss of 5.1% was observed for one animal (No. 13) in the 10 % (w/v) dose group but this was considered as animal variability and not related to test item. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present assay, 2,2`-Dichlorodiethyl ether, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
- Executive summary:
The aim of this study was to determine the skin sensitisation potential of 2,2`-Dichlorodiethyl ether following dermal exposure. The study was performed according to OECD Test Guideline No. 429 and EC No 440/2008 Guideline B.42.
Based on the results of the Preliminary Compatibility Test and on the recommendations of the OECD Guideline, the test item was formulated in acetone:olive oil 4:1 (v:v) mixture (abbreviated as AOO). The Preliminary Irritation / Toxicity Test was performed in CBA/CaOlaHsd mice using two doses: 100 % (undiluted) and 50 % (w/v) in AOO. Based on the observations recorded in the preliminary test, the 50 % (w/v) was selected as top dose for the main test.
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 μL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).
No mortality or signs of systemic toxicity were observed during the study. No treatment related effects were observed on the mean body weight changes. The stimulation index values were 1.1, 1.0 and 1.3 at concentrations of 50, 25 and 10 % (w/v), respectively. The result of the positive control substance α-Hexylcinnamaldehyde (HCA) showed a significant lymphoproliferative response (stimulation index value of 8.6), which confirmed the validity of the assay.
In conclusion, under the conditions of the present assay 2,2`-Dichlorodiethyl ether, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
1. Skin sensitisation:
Based on a study performed according to OECD Test Guideline No. 429 and EC No 440/2008 Guideline B.42 (reliability 1), Bis(2-chloroethyl) ether was found to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay. Accordingly, the substance shall not be classified as skin sensitiser.
1. Respiratory sensitisation:
No study is available regarding the respiratory sensitisation potential of Bis(2-chloroethyl) ether. In addition, information regarding this endpoint is not required according to Annex VIII of Regulation EC No. 1907/2006. The substance is not classified as repiratory sensitiser.
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.