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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 February - 6 June 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: J. Schitkovits, A-2620 Natschbach- Weight at study initiation: Animal No. 41: 3.2 kg, Animal No. 42: 3.2 kg, Animal No. 43: 2.9 kg- Weith at study termination: Animal No. 41: 3.4 kg, Animal No. 42: 3.2 kg, Animal No. 43: 2.9 kg- Housing: Optimal hygienic conditions, individual caging in metal wire cages, Ehret GmbH, type KK016R, 79 cm x 59 cm x 35 cm- Diet: Altromin 2023 diet for rabbtis, ad libitum.- Water: tap water from an automatical watering system, ad libitum.- Acclimation period: 6 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): average of 20 °C - Humidity (%): average of 54 %.- Air changes (per hr): 12 per hour.- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs light.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL per animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE- Area of exposure: 2.5 cm x 2.5 cm at dorsal area of the trunk (dorsal thoracal region).- Type of wrap if used: Samples of the test substance were spread on cellulose patches and were applied to the test sites. They were held in place by fixing them marginally with non irritating tapes. The applicatio nsites were covered semi-occlusively by a dressing. Access by the animal to the application sites was prevented by a plastic collar.REMOVAL OF TEST SUBSTANCE- Time after start of exposure: duration of exposure was 4 hours. At the end of the exposure period the dressing, the tapes with the patches and the collar were removed, residual test substance was removed with wet Kleenex-tissues.SCORING SYSTEM:The treated ares and the surrounding untreated skin (control area) were examined for erythema/eschar and oedema as well as for other local signs 1, 24, 48 and 72 hours after patch removal.The skin was examined using a light source KL 1500 electronic. Dermal irritation was described and recorded according to the scoring scheme for acute dermal irritation/corrosion tests. (see below).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all 3 animals
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 3 animals
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All areas treated with the test substance and all control areas were normal before the application.Erythema/eschar: Not observed at any observation point.Oedema: Not observed at any observation point.
- Other effects:
- None
Any other information on results incl. tables
| Mean Scores for Animal No.: | ||
| 41 | 42 | 43 |
Erythema / Eschar: | 0.0 | 0.0 | 0.0 |
Oedema: | 0.0 | 0.0 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test substance did not cause any adverse skin reactions in this study.
- Executive summary:
Aim of the study
The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits.
Methods
Methods and investigations were performed in accordance with the OECD Guideline 404 and the Directive 92/69/EC, method B.4.
Administration of the test substance
0.5 mL "diethylacetylsuccinate" was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by a semi-occlusive dressing. The duration of the exposure was 4 hours.
Investigations
· Body weights: at the start and at the termination of the test.
· General signs of toxicity: once daily.
· Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).
Results
General signs of toxicity: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Skin examinations: All exposed skin sites were normal at each examination term.
Conclusion
The following mean scores were calculated for each animal from the examinations 24 h, 48 h and 72 h p.a.:
Mean Scores for Animal No.:
41
42
43
Erythema / Eschar
0.0
0.0
0.0
Oedema
0.0
0.0
0.0
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