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EC number: 203-311-1 | CAS number: 105-58-8
- 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 irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- performed according to an official method by a renowned institution using "Diäthylcarbonat", no info about purity, origin or batch of the test substance, no GLP, no control animals, in general good documentation of methodology and evaluation of results
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.41
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: "Lippische Versuchstierzucht / Exertal 1"
- Sex: male
- Weight at study initiation: 2.3 kg (average)
- Housing: kept in single cages
- Diet ad libitum: "mümmel z"; English: "ssniff / Soest"
- Water ad libitum
- Acclimation period: 7-14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: no data - Type of coverage:
- occlusive
- Preparation of test site:
- other: hair cut with electric hair cutter and not scarified/scarified with scarificator
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 microliter - Duration of treatment / exposure:
- 24 h
- Observation period:
- 8 d; times of observation, after start of application of test substance: 24 h (detailed: 24.5 h), 48 h (data not reported), 72 h, 8d
- Number of animals:
- 6
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h and 72 h
- Score:
- 0.3
- Reversibility:
- other: no erythema at all; yes for edema
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h and 72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: until 72 h
- Remarks on result:
- other: single scores: 0, 1, 1, 1, 1, 2; not scarified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: until 72 h
- Remarks on result:
- other: single scores: 0, 0, 0, 1, 0, 0; scarified
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: conclusion in study report
- Conclusions:
- The test substance diethyl carbonate was not irritating to rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test animal: mouse (not first choice as test animal for skin irritation test); results on skin irritation from a dose range finding test in the course of determining the skin sensitisation potential of diethyl carbonate
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 429 (Skin sensitisation test)
- Principles of method if other than guideline:
- Preliminary irritation/toxicity screen test in the course of a skin sensitisation study with diethyl carbonate (there: dose range finding test).
See also under 7.4.1. Skin sensitisation (7.4.1.001) for further details. - GLP compliance:
- yes (incl. QA statement)
- Species:
- mouse
- Details on test animals or test system and environmental conditions:
- Info specific to dose range finding animals in skin sensitisation test:
Species and strain: CRL: NMRI BR mice
Source: TOXI-COOP ZRT. H-1103, Budapest, Cserkesz u. 90.
Hygienic level at arrival: SPF
Hygienic level during the test: Good conventional
Justification of strain: The aim of the preliminary screen was to assess the ability of the test item causing irritation and/or systemic toxicity (not the sensitizing effect), CRL: NMRI BR mice were used in the pre-screen test for a better visibility of erythema and oedema.
Number of animals: 4 animals (2 animals/group);
Sex: Female, nulliparous, non pregnant
Age of animals: Young adult mice, 6-7 weeks old
Husbandry:
Animal health: Only healthy animals were used
Housing during acclimatization period: Grouped caging in small groups
Housing during the test: Grouped caging (4 animals/cage)
Cage type: Type II. Polypropylene / polycarbonate
Bedding: Laboratory bedding
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Housing/Enrichment: Mice were group-housed to allow social interaction, and with deep wood sawdust bedding, to allow digging and other normal rodent activities.
Food and Water Supply:
Animals received ssniff (R) SM R/M-Z+H complete diet for rats and mice produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, and tap water from municipal supply, as for human consumption, from a bottle ad libitum. For contents of standard diet for rats and mice and actual batch number of the diet see Appendix III.
Bedding:
Lignocel (R) Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH+Co.KG (D-73494 Rosenberger (Germany) Holzmühle 1) was available to animals during the study.
Identification of Animals:
The individual identification of the animals was performed by numbers on the tail. The cages were marked with identification cards, with information about study number, sex, dose group and individual animal numbers.
Randomization:
The animals were set in order of their body weight. The animals were randomly assigned to control and test groups using a randomization scheme. The randomization was checked by computer software according to the actual body weights verifying the homogeneity and deviations between the groups. - Amount / concentration applied:
- 100 % (the undiluted test item itself)
50 % in AOO (acetone:olive oil = 4:1 (v/v)) - Irritation parameter:
- erythema score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- non of the animals showed any sign of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Diethyl carbonate did not cause skin irritation in this test. All values of erythema scores were 0.
This is only supplementary data as the test is not officially acknowledged (e.g. by OECD) to evaluate the skin irritation properties of a substance. - Endpoint:
- skin irritation / corrosion
- Remarks:
- no data
- Type of information:
- other: no data
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only two one-sentence statements without background data; data from HSDB database; content in original publication that is referred to on HSDB was checked and verfied
- GLP compliance:
- not specified
- Endpoint:
- skin irritation: in vitro / ex vivo
- Remarks:
- In-vitro data on skin irritation is not provided due to availability of in-vivo data.
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
8 d value with no valuation for irritation index as value was “0” for all six animals, scarified and non-scarified areas.
According to the preliminary test results, test item concentration of 100 % (the undiluted test item) was selected as the highest test concentration in the main test (for skin sensitisation).
No mortality or any signs of systemic toxicity were observed. No signs of irritation (indicated by an erythema score ≥ 3 and/or an increased ear thickness of ≥ 25 % on any day of measurement) were observed in the treatment groups.
Results table:
Summarised table of erythema scores in the preliminary irritation/toxicity test:
Dose group | Animal no. | Ears | Day | Day | Day | Day | Day | Day | Day | Day | Day |
1 | 1 | 2 | 2 | 3 | 3 | 4 | 5 | 6 | |||
PT | AT | PT | AT | PT | AT | NT | NT | NT | |||
Diethyl carbonate 100 % | 110 | Left | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diethyl carbonate 100 % | 110 | Right | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diethyl carbonate 100 % | 111 | Left | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diethyl carbonate 100 % | 111 | Right | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diethyl carbonate 50 % | 112 | Left | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diethyl carbonate 50 % | 112 | Right | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diethyl carbonate 50 % | 113 | Left | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diethyl carbonate 50 % | 113 | Right | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PT = prior to treatment
AT = after treatment
NT = no treatment
As stated in HSDB database (http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB):
Human Toxicity Excerpts:
MODERATELY TOXIC BY INGESTION & INHALATION; STRONG IRRITANT.
[Hawley, G.G. The Condensed Chemical Dictionary. 9th ed. New York: Van Nostrand Reinhold Co., 1977., p. 287] **PEER REVIEWED**
Skin, Eye and Respiratory Irritations:
STRONG IRRITANT.
[Hawley, G.G. The Condensed Chemical Dictionary. 9th ed. New York: Van
Nostrand Reinhold Co., 1977., p. 287] **PEER REVIEWED**
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- performed according to an official method by a renowned institution using "Diäthylcarbonat", no info about purity, origin or batch of the test substance, no GLP, no control animals, in general good documentation of methodology and evaluation of results
- Qualifier:
- according to guideline
- Guideline:
- other: "Test for eye irritants", Code of Federal Regulations, Title 16, Section 1500.42
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: "Lippische Versuchstierzucht / Exertal 1"
- Sex: male
- Weight at study initiation: 2.3 kg (average)
- Housing: kept in single cages
- Diet ad libitum: "mümmel z"; English: "ssniff / Soest"
- Water ad libitum
- Acclimation period: 7-14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 microliter - Duration of treatment / exposure:
- 8 d (at no stage flushing of eye after substance was applied)
- Observation period (in vivo):
- 8 d; times of observation, after application of test substance: 24 h, 48 h, 72 h, 8d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing/flushing: not done
SCORING SYSTEM: - Irritation parameter:
- cornea opacity score
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Time point:
- 72 h
- Score:
- 0
- Irritant / corrosive response data:
- Results of the test
(1)Cornea
(A) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(B) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(2)Iris
(A) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(3)Conjunctiva
(A) : 0, 0, 0, 0, 1, 1 after 24 h; 0, 0, 0, 0, 0, 1 after 48 h; 0 for all 6 animals after 72 h and 8 d
(B) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(C) : 0 for all 6 animals after 24, 48, 72 h and 8 d
24 h values, sums of a+b+c: 0, 0, 0, 0, 2, 2
48 h values, sums of a+b+c: 0, 0, 0, 0, 0, 2
72 h values, sums of a+b+c: 0, 0, 0, 0, 0, 0
Primary irritation value = (15*0 + 2 + 2 + 2) / 18 = 0.3
Classification: 0 – 10 = not irritating
On a scale of 0-110 for primary eye irritation, the substance has reached 0.3 in the present study and will therefore be classified as not irritating. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: conclusion in study report
- Conclusions:
- The test substance diethyl carbonate was not irritating to the rabbits eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- not specified
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only two one-sentence statements without background data; data from HSDB database; content in original publication that is referred to on HSDB was checked and verfied
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- In-vitro data on eye irritation is not provided due to availability of in-vivo data.
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
8d results not included in the calculation of irritation index. All values were zero.
As stated in HSDB database (http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB):
Human Toxicity Excerpts:
MODERATELY TOXIC BY INGESTION & INHALATION; STRONG IRRITANT.
[Hawley, G.G. The Condensed Chemical Dictionary. 9th ed. New York: Van Nostrand Reinhold Co., 1977., p. 287] **PEER REVIEWED**
Skin, Eye and Respiratory Irritations:
STRONG IRRITANT.
[Hawley, G.G. The Condensed Chemical Dictionary. 9th ed. New York: Van Nostrand Reinhold Co., 1977., p. 287] **PEER REVIEWED**
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
The study was performed according to an official method (Code of
Federal Regulations, Title 16, Section 1500.41).
Justification for selection of eye irritation endpoint:
The study was performed according to an official method ("Test for
eye irritants", Code of Federal Regulations, Title 16, Section 1500.42).
Justification for classification or non-classification
The test substance diethyl carbonate was not irritating to rabbit skin (see endpoint record 7.3.1.001, study report, Saltigo, key data) as well as not irritating to the rabbits eye (see endpoint record 7.3.2.001, study report, Saltigo, key data). According to these results there is no need to perform a respiratory irritation test.
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