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EC number: 205-524-5 | CAS number: 142-16-5
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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:
- 1994-02-18 to 1994-04-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(2-ethylhexyl) maleate
- EC Number:
- 205-524-5
- EC Name:
- Bis(2-ethylhexyl) maleate
- Cas Number:
- 142-16-5
- Molecular formula:
- C20H36O4
- IUPAC Name:
- bis(2-ethylhexyl) but-2-enedioate
- Reference substance name:
- Dioctyl maleate
- EC Number:
- 220-835-6
- EC Name:
- Dioctyl maleate
- Cas Number:
- 2915-53-9
- Molecular formula:
- C20H36O4
- IUPAC Name:
- dioctyl but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): Dioctylmaleinat; (Z)-2-Butendisäure-bis-(2ethylhexyl)ester
- Substance type: active substance
- Physical state: colourless-yellowish liquid
- Analytical purity: 96.1%
- Lot/batch No.: Ch 35559, Beh. 828
- Expiration date of the lot/batch: August 1994
- Storage condition of test material: Under exclusion of oxygen in a tightly closed container under a laboratory flu
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach an der Riss, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.3 - 2.6 kg
- Sex: male
- Housing: individual housing
- Diet: Ssniff K 4 - Alleindiät for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³ of the undiluted test item - Duration of treatment / exposure:
- Animals were exposed over a period of 4 hours.
- Observation period:
- 30 - 60 min, 24, 48 and 72 hours after patch removal and on Day 6, 8, 10 and 13 after patch removal
- Number of animals:
- Three. Each animal was individually labelled with an earmark.
- Details on study design:
- TEST SITE
- Area of exposure: skin area of about 6 cm²
- % coverage: 100% of the exposed area
- Type of wrap if used: gauze bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After patch removal, the skin was washed with warm water
- Time after start of exposure: 4
SCORING SYSTEM: according to the guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- A table describing the effects observed for each animal is given in the sector "Remarks on results"
- Other effects:
- At day 6 after the end of the exposure period, dandering skin has been observed at all animals. On day 13 of exposure, no skin effects were observed anymore.
Any other information on results incl. tables
Table 1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
30 - 60 min |
2/2/1 |
2/1/0 |
24 h |
2/2/2 |
2/2/2 |
48 h |
2/2/2 |
1/1/1 |
72 h |
2/2/2 |
1/1/1 |
Average 24h, 48h, 72h |
2/2/2 |
1.33/1.33/1.33 |
Reversibility*) |
c/c/c |
c/c/c |
*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observations, dioctyl maleate is a mild or slightly skin irritating but does not require classification.
- Executive summary:
In a primary dermal irritation study, three adult male Himalayan rabbits were dermally exposed to 0.5 cm³ of dioctyl maleate (purity 96.1%) for 4 hours to about 6 cm² of the body surface area. Animals then were observed for 13 days. Irritation was scored by the method of OECD 404.
At 24 hours after end of exposure, all animals showed clearly defined erythema and slight edema. After 48 to 72 hours after the end of the exposure period, all animals still showed clearly defined erythema, but only minimal edema and fully reversible within 8 days.
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