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EC number: 214-223-8 | CAS number: 1115-30-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 February - 4 May 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- test was performed in 1999.
Test material
- Reference substance name:
- Diethyl acetylsuccinate
- EC Number:
- 214-223-8
- EC Name:
- Diethyl acetylsuccinate
- Cas Number:
- 1115-30-6
- Molecular formula:
- C10H16O5
- IUPAC Name:
- 1,4-diethyl 2-acetylbutanedioate
- Details on test material:
- - Name of test material (as cited in study report): "Diethylacetylsuccinate"- Physical state: Bright yellow liquid.- Lot/batch No.: SLBE 101- Solubility i nwater: ca. 15g/L- Melting point: -8 °C- Boiling point: 180 °C/67 mbar- Density: 1.081- Expiration date of the lot/batch: December 1999- Storage condition of test material: In the refrigerator, in the dark.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen.- Age at study initiation: Approx. 6 weeks at the first application- Weight at first application: 348 g - 459 g- Housing: Single caging in Makrolon cages type III (23 cm x 39 cm x 18 cm) with wire mesh lids- Diet (ad libitum): Altromin Standard Diet No. 3022. Analysis of the feed for ingredients and contaminants are performed randomly by Altromin GmbH, D-32791 Lage.- Water (ad libitum): Tap water, acidified with HCl to pH = 3, offered in Makrolon bottles with stainless steel canules ad libitum. - Acclimation period: Approx. 2 weeks.ENVIRONMENTAL CONDITIONS- Temperature: Approx. 22 °C- Humidity: Approx. 60 %.- Air changes (per hr): 12- Photoperiod: 12 hrs dark, 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: corn oil/acetone (9+1, v/v) for intradermal induction exposure
- Concentration / amount:
- 5 % (v/v) in corn oil/acetone (9+1, v/v) for the intradermal induction100 % (undiluted) for the epicutaneous induction and100 % (undiluted) for the challenge exposure
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: corn oil/acetone (9+1, v/v) for intradermal induction exposure
- Concentration / amount:
- 5 % (v/v) in corn oil/acetone (9+1, v/v) for the intradermal induction100 % (undiluted) for the epicutaneous induction and100 % (undiluted) for the challenge exposure
- No. of animals per dose:
- 20 animals were used as test substance group and 10 animals as negative control group. Spare animals: One additional animal per group was kept and administered under the same conditions as the other animals of the respective group. Findings on the spare animals were only to be incorporated into this report if other animals of the test substance group or of the control group would have died spontaneously. Otherwise, the skin reactions of these animals were not used for the interpretation of the results.
- Details on study design:
- RANGE FINDING TESTS:To obtain the appropriate concentrations of the test substance for the definitive study, a preliminary test was carried out with 3 female guinea pigs. 4 different concentrations of the test substance and FCA were administered intradermally and 7 days later 4 concentrations of the test substance were administered epicutaneously. The modes of application were the same as in the definitive study. The duration of the epicutaneous exposure was 24 hours.The test substance was dissolved in corn oil for the intradermal injections and in acetone for the epicutaneous administration. For results see "Any other information on results incl. tables".MAIN STUDYA. INDUCTION EXPOSURE- Day of exposures: Intradermally on Day 0; epicutaneously on Day 7.- Method, intradermally: Hair was clipped. The application site for all injections was an area of about 2 cm x 4 cm in the interscapular region. In each of the injection rows listed in "Any other information on methods and materials incl. tables" two intradermal injections were made side by side. A volume of 0.1 ml was applied for each injection site.- Method, epicutaneously: Test patches (Pur Zellin-Tupfer, obtained by Fa. Hartmann , A-2355 Wiener Neudorf), about 2 cm x 4 cm, soaked with the test substance (test substance group) and with deionised water (control group), respectively, were applied to the area of the intradermal injections. They were fixed with a strip of non-irritating tape ("Blenderm*" surgical tape, hypoallergenic, 3M, made in USA, Medical Products Division, St. Paul, MN 551444). The area of administration was then covered occlusively with aluminium foil and finally fixed with "Fixomull* stretch" (self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, D-20245 Hamburg). The exposure time was 48 hours.- Concentrations: 5 % (v/v) in corn oil for the intradermal induction, 100 % (undiluted) for the epicutaneous induction.B. CHALLENGE EXPOSURE- No. of exposures: 1- Day(s) of challenge: Day 21- Exposure period: 24 hours- Site: left flanks: test substance, right flanks: deionised water- Concentrations: 100 % (undiluted)- Evaluation: 24 h after the end of the exposure period (Day 23) and a second skin examination further 24 h later (Day 24).
- Challenge controls:
- A negative control group (10 animals) was tested in parallel.
- Positive control substance(s):
- yes
- Remarks:
- HEXYL CINNAMIC ALDEHYDE (HCA), controls tests performed periodically, data attached to the report
Study design: in vivo (LLNA)
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- - Randomisation: The individual animals were allocated to their groups by random numbers. The order of animals for the evaluation of the skin of test and control animals was randomised. A "blind" evaluation was performed.The t-test was used to evaluate differences of the mean body weiths between the test substance group and dthe control group on Day 0 and 24 (P=0.05).The t-test was used to evaluate differences of the mean body weights between the test substance group and the control group on Days 0 and 25 of each step (P = 0.05).
Results and discussion
- Positive control results:
- See attachment.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Test substance 100 % (undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Test substance 100 % (undiluted). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Test substance 100 % (undiluted)
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema and severe erythema/oedema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Test substance 100 % (undiluted). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: very slight erythema and severe erythema/oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Test substance 100 % (undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Test substance 100 % (undiluted). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Test substance 100 % (undiluted)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- severe erythema/oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Test substance 100 % (undiluted). No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: severe erythema/oedema.
Any other information on results incl. tables
Results of the preliminary test:
To obtain the appropriate concentrations of the test substance for the definitive study, a preliminary test was carried out with 3 female guinea pigs, pretreated with FCA. 4 different concentrations of the test substance were administered intradermally and 7 days later
4 concentrations of the test substance were administered epicutaneously. The modes of application were the same as in the definitive study. The duration of the epicutaneous exposure was 24 hours.
The test substance was dissolved in corn oil for the intradermal injections and in acetone for the epicutaneous administration.
Results (scores) of the preliminary test (for scale see Table 4):
Intradermal exposure:
test substance | Scores for animal Nos. * | ||
concentration (w/v) | 4 | 5 | 6 |
20.0 % | 3/3 | 3/3 | 3/3 |
5.0 % | 2/1 | 0/0 | 3/3 |
1.0 % | 0/0 | 0/0 | 0/0 |
0.1 % | 0/0 | 0/0 | 0/0 |
* first numbers / second numbers: scores 24/48 hours after intradermal injection
Epicutaneous exposure:
test substance | Scores for animal Nos. * | ||
concentration (w/w) | 4 | 5 | 6 |
100 % | 0/0 | 0/0 | 0/0 |
50 % | 0/0 | 0/0 | 0/0 |
10 % | 0/0 | 0/0 | 0/0 |
1 % | 0/0 | 0/0 | 0/0 |
* first numbers / second numbers: scores 24/48 hours after the end of the epicutaneous exposure
For the main study the following concentrations of "DIETHYLACETYLSUCCINATE" were therefore selected:
5 % (v/v) in corn oil/acetone (9+1,v/v) for the intradermal induction, 100 % (undiluted) for the epicutaneous induction and for the challenge exposure.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- 10 % of the test substance group aminals were regarded as sensitised. According to the EC Guideline 93/21, the threshold limit for a classification of a test substance as a sensitiser is 30 % of positively reacting animals in the GPMT. As the sensitisation rate in this study was clearly below this threshold, the test substance needs not to be labelled with "R43 may cause sensitisation by skin contact".
- Executive summary:
Method
Twenty female guinea pigs were used as a test substance group and another 10 females were used as a negative control group. There were two induction exposures (intradermally and epicutaneously) and one epicutaneous challenge exposure. Test substance concentrations were
5 % (v/v) in corn oil/acetone (9+1, v/v) for the intradermal induction
100 % (undiluted) for the epicutaneous induction and
100 % (undiluted) for the challenge exposure.
Investigations performed were in conformance with the OECD-Guideline 406 and with the Directive 96/54/EC, B.6. Application of Freund's complete adjuvant was included in the intradermal exposure of both groups to enhance a possible sensitisation. Occlusive dressings were used for the epicutaneous exposures.
Results
General
All animals survived till the end of the study. Intradermal injections of Freund's adjuvant caused severe local reactions in all animals, a known effect of the adjuvant. Sensitisation excluded, no other adverse effects were noted.
Skin reactions after the challenge exposure
The results of these skin examinations were decisive for the grading of the potential of sensitisation.
The control sites of all animals of both groups were normal at each reading time.
In the control group, no positive skin reactions were noted in any animal.
In the test substance group, very slight to severe erythema and/or oedema were noted in 2/20 animals at the test substance treated areas 24 hours and/or 48 hours after the end of the challenge exposure. Therefore 2/20 animals (10 % of the test substance group animals) were regarded as sensitised.
According to the EC Guideline 93/21, the threshold limit for a classification of a test substance as a sensitiser is 30 % of positively reacting animals in the Guinea Pig Maximisation Test. As the sensitisation rate in this study was clearly below this threshold, the test substance "DIETHYLACETYLSUCCINATE" needs not to be labelled with "R43 May cause sensitisation by skin contact".
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