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EC number: 229-114-0 | CAS number: 6413-10-1
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The methodology and results were reported in very limited detail. It was not possible to assess the quality of the reported results from the data presented. From the limited information available, the study appears to have been conducted in compliance with good scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- A Maximisation test was conducted in line with the method described in the Journal of Investigative Dermatology, Volume 47, No. 5; 1966; 393-409. During the test, the test material was applied under occlusion to the same sites on the volar aspects of the forearms of all subjects, for five alternate day 48 hour periods. The patch sites were pre-tested for 24 hours with 5 % aqueous sodium lauryl sulphate under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of the test material were applied under occlusion for 48 hours. Challenge applications were preceded by 30 minute applications of 5 % aqueous sodium lauryl sulphate under occlusion for without sodium lauryl sulphate treatment on the right side. Additional sodium lauryl sulphate controls were placed on the left and petroleum on the right. The challenge sites were read at 48 and 72 hours. Questionable reactions were biopsied and subjects re-tested whereby the test material was applied at new sites one week later and examined in the same manner.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
Test material
- Reference substance name:
- Ethyl 2-methyl-1,3-dioxolane-2-acetate
- EC Number:
- 229-114-0
- EC Name:
- Ethyl 2-methyl-1,3-dioxolane-2-acetate
- Cas Number:
- 6413-10-1
- Molecular formula:
- C8H14O4
- IUPAC Name:
- ethyl 2-(2-methyl-1,3-dioxolan-2-yl)acetate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 35 healthy inmate volunteers were screened, and 32 completed the study (see Tables 1 and 2).
- Sex: Male
- Age: 21 - 49 - Clinical history:
- The volunteers were reported as healthy.
- Route of administration:
- dermal
- Details on study design:
- PRE-TEST
- Method: Before the Maximisation test was conducted, the test material was pre-tested on all subjects in order to determine whether sodium lauryl sulfate pre-treatment was required. A patch of the test material was applied to normal sites on the backs for 48 hours under occlusion.
- Results of pre-test: No significant evidence of irritation was observed and all subjects were pre-tested with 5 % aqueous sodium lauryl sulphate.
TYPE OF TEST USED: Maximization test (epicutaneous test).
ADMINISTRATION
- Pre-treatment of test site: The test site on the volar forearm was pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion.
- Type of application: occlusive.
- Induction exposure: Five 48 hour exposures on alternative days.
- Rest period: A 10-14 day rest period was left between the induction and challenge exposures.
- Challenge exposure: 48 hour applications to fresh test sites.
- Post-exposure treatment: Preceding the challenge application, 30 minute 2 % aqueous sodium lauryl sulphate applications were performed without sodium lauryl sulphate treatment on the right side. Additional sodium lauryl sulphate controls were placed on the left and petroleum on the right.
- Concentrations: Not reported.
- Testing/scoring schedule: the challenge site was assessed for dermal reactions on removal of the patch at 48 and 72 hours.
Results and discussion
- Results of examinations:
- There were no instances of contact-sensitization in any of the volunteer’s exposed to the test material.
Any other information on results incl. tables
Table 1: Results (treatment sites)
Subject no. |
Challenge |
Race |
Age |
Sex |
|||
SLS |
No SLS |
||||||
48 hours |
72 hours |
48 hours |
72 hours |
||||
1 |
0 |
0 |
0 |
0 |
WHITE |
40 |
M |
2 |
+- |
B |
+- |
0 |
WHITE |
45 |
M |
3 |
0 |
0 |
0 |
0 |
MEXICAN |
34 |
M |
4 |
0 |
0 |
0 |
0 |
ORIENTAL |
33 |
M |
5 |
PAROLED |
WHITE |
33 |
M |
|||
6 |
0 |
0 |
0 |
0 |
WHITE |
35 |
M |
7 |
PAROLED |
MEXICAN |
34 |
M |
|||
8 |
+- |
0 |
0 |
BLACK |
29 |
M |
|
9 |
+- |
0 |
0 |
0 |
BLACK |
27 |
M |
10 |
0 |
0 |
0 |
0 |
WHITE |
28 |
M |
11 |
0 |
0 |
0 |
0 |
INDIAN |
25 |
M |
12 |
+- |
0 |
0 |
0 |
WHITE |
28 |
M |
13 |
0 |
0 |
0 |
0 |
WHITE |
28 |
M |
14 |
0 |
0 |
+- |
0 |
INDIAN |
29 |
M |
15 |
0 |
0 |
0 |
0 |
BLACK |
29 |
M |
16 |
0 |
0 |
0 |
0 |
WHITE |
31 |
M |
17 |
TRANSFERRED |
BLACK |
31 |
M |
|||
18 |
0 |
0 |
0 |
0 |
WHITE |
26 |
M |
19 |
+- |
0 |
+- |
+- |
WHITE |
23 |
M |
20 |
+- |
0 |
+- |
0 |
WHITE |
28 |
M |
21 |
0 |
B |
+- |
0 |
WHITE |
32 |
M |
22 |
+- |
0 |
0 |
0 |
BLACK |
43 |
M |
23 |
0 |
0 |
0 |
0 |
BLACK |
23 |
M |
24 |
0 |
B |
0 |
0 |
WHITE |
42 |
M |
25 |
0 |
0 |
+- |
0 |
BLACK |
24 |
M |
26 |
0 |
0 |
0 |
0 |
BLACK |
38 |
M |
27 |
+- |
0 |
+- |
0 |
BLACK |
42 |
M |
28 |
0 |
0 |
0 |
0 |
WHITE |
29 |
M |
29 |
0 |
0 |
0 |
0 |
BLACK |
35 |
M |
30 |
+- |
B |
0 |
0 |
WHITE |
40 |
M |
31 |
0 |
0 |
+- |
0 |
WHITE |
44 |
M |
32 |
+- |
H |
+- |
0 |
BLACK |
36 |
M |
33 |
0 |
0 |
0 |
0 |
WHITE |
49 |
M |
34 |
+- |
B |
0 |
0 |
WHITE |
21 |
M |
35 |
0 |
0 |
0 |
0 |
INDIAN |
32 |
M |
Table 2: Results (control sites)
Subject no. |
Challenge |
Race |
Age |
Sex |
|||
SLS |
No SLS |
||||||
48 hours |
72 hours |
48 hours |
72 hours |
||||
1 |
0 |
0 |
0 |
0 |
WHITE |
40 |
M |
2 |
+- |
B |
0 |
B |
WHITE |
45 |
M |
3 |
+- |
B |
0 |
0 |
MEXICAN |
34 |
M |
4 |
0 |
0 |
0 |
0 |
ORIENTAL |
33 |
M |
5 |
PAROLED |
WHITE |
33 |
M |
|||
6 |
0 |
0 |
0 |
0 |
WHITE |
35 |
M |
7 |
PAROLED |
MEXICAN |
34 |
M |
|||
8 |
+- |
0 |
+- |
0 |
BLACK |
29 |
M |
9 |
0 |
0 |
0 |
0 |
BLACK |
27 |
M |
10 |
0 |
0 |
0 |
0 |
WHITE |
28 |
M |
11 |
0 |
0 |
0 |
0 |
INDIAN |
25 |
M |
12 |
0 |
0 |
0 |
0 |
WHITE |
28 |
M |
13 |
0 |
0 |
0 |
0 |
WHITE |
28 |
M |
14 |
+- |
0 |
0 |
0 |
INDIAN |
29 |
M |
15 |
0 |
0 |
0 |
0 |
BLACK |
29 |
M |
16 |
0 |
0 |
0 |
0 |
WHITE |
31 |
M |
17 |
TRANSFERRED |
BLACK |
31 |
M |
|||
18 |
+- |
0 |
+- |
0 |
WHITE |
26 |
M |
19 |
0 |
0 |
0 |
0 |
WHITE |
23 |
M |
20 |
0 |
0 |
0 |
0 |
WHITE |
28 |
M |
21 |
0 |
B |
0 |
0 |
WHITE |
32 |
M |
22 |
0 |
0 |
0 |
0 |
BLACK |
43 |
M |
23 |
0 |
0 |
0 |
0 |
BLACK |
23 |
M |
24 |
0 |
B |
0 |
0 |
WHITE |
42 |
M |
25 |
0 |
0 |
0 |
0 |
BLACK |
24 |
M |
26 |
0 |
0 |
0 |
0 |
BLACK |
38 |
M |
27 |
+- |
0 |
0 |
0 |
BLACK |
42 |
M |
28 |
0 |
0 |
0 |
0 |
WHITE |
29 |
M |
29 |
0 |
0 |
0 |
0 |
BLACK |
35 |
M |
30 |
0 |
B |
0 |
0 |
WHITE |
40 |
M |
31 |
0 |
0 |
+- |
0 |
WHITE |
44 |
M |
32 |
0 |
0 |
0 |
0 |
BLACK |
36 |
M |
33 |
0 |
0 |
0 |
0 |
WHITE |
49 |
M |
34 |
0 |
0 |
0 |
0 |
WHITE |
21 |
M |
35 |
0 |
0 |
0 |
0 |
INDIAN |
32 |
M |
Applicant's summary and conclusion
- Conclusions:
- There were no instances of contact sensitisation from the test material during the Maximisation Test. It is therefore considered unlikely that the test material is a skin sensitiser.
- Executive summary:
A Maximisation Test was conducted to determine the skin sensitisation potential of the test material in line with the method described in the Journal of Investigative Dermatology, Volume 47, No. 5; 1966 p 393-409. During the study, the test material was applied under occlusion to sites on the volar aspects of the forearms of all subjects, for five 48 hour periods administered on alternate days. The patch sites were pre-tested for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. Following a 10 -14 day rest period, challenge patches of the test material were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2 % aqueous sodium lauryl sulphate under occlusion without sodium lauryl sulphate treatment on the right side. Additional sodium lauryl sulphate controls were placed on the left and petroleum on the right. The challenge sites were read at 48 and 72 hours. Questionable reactions were biopsied and followed by retests, whereby the test material was applied at new sites one week later; they were examined in the same manner.
Before the Maximisation Test was conducted, the test material was pre-tested on all subjects in order to determine whether sodium lauryl sulphate pre-treatment was required. A patch of the test material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-tested with 5% sodium lauryl sulphate.
Under the conditions of the study there were no instances of contact sensitisation from the test material during the Maximisation Test. It is therefore considered unlikely that the test material is a skin sensitiser.
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