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EC number: 203-328-4 | CAS number: 105-76-0
- 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:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to OECD guideline 404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dibutyl maleate
- EC Number:
- 203-328-4
- EC Name:
- Dibutyl maleate
- Cas Number:
- 105-76-0
- Molecular formula:
- C12H20O4
- IUPAC Name:
- dibutyl but-2-enedioate
- Details on test material:
- Dibutyl maleate
clear colourless liquid
Batch #: FASS 859 vom 24.02.98
Expiration date: 1 Nov 1999
Purity: 98.5%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source - Commercial supplier
Weight at study - 2.2 to 2.6 kg
Age - at least 11 weeks old
Acclimation - a period of five days prior to the start of the study.
Housing - individually in stainless steel cages
Diet - standard laboratory rabbit diet ad libitum
Drinking - potable water ad libitum
Test - routine physical and chemical examination of drinking water was conducted
Animal room temperature was maintaned at 15 to 16 Celsius degree and relative humidity at 38 to 57%. These parameters were recorded daily.
Lighting - available 12 hours period in each 24 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- Rabbits were each administered a single dermal dose of 0.5 ml of DBM.
- Observation period:
- Rabbits were observed for up to eight days.
- Number of animals:
- Three
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 72h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Well-defined erythema was observed in rabbit # 1 and very slight erythema in rabbits #2 and 3. The rabbits were gradually recovered by day 5, 7 and 8, respectively.
Any other information on results incl. tables
Dermal Reactions
Rabbit No/Sex |
E=Erythema O= Oedema |
Day |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
||
1627/Female |
E |
0 |
2 |
2 |
1 |
1 |
1 |
0 |
|
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1628/Female |
E |
0 |
1 |
1 |
1 |
0 |
|
|
|
|
O |
0 |
0 |
0 |
0 |
0 |
|
|
|
1637/Female |
E |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* Approximately 60 minutes after removal of the dressing
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dibutyl maleic is slightly irritant to the skin.
- Executive summary:
The potential for DBM was assessed according to the OECD guideline 404 in an acute dermal irritation/corrosion test. The test substance was administered in a single dermal dose of 0.5 ml and observed for eight days. The reaction in all three animals were resolved by Day 5, 7,and 8 respectively. DBM was determined to be slightly irritating in all three rabbits during the observation period. One animal showed a well-defined dermal irritanting response on days 2 -3 only. Based on the results, it was concluded that DBM is a slightly to well defined irritating to the skin.
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