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Diss Factsheets
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EC number: 413-390-6 | CAS number: 149144-85-4
- 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:
- June 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): COSMACOL EMI
- Substance type: pure active substance
- Physical state: liquid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: conelli Arona (NO), Italy
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: singly in stainless steel cages (dimensions: 450x500x380 mm) equipped with automatic washing cycle
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
Temperature and humidity were regulated by a conditioning plant and were continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01-JUN-1992 To: 08-JUN-1992
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: sesame seed oil
- Controls:
- other: non-treated area of the skin
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 500 mg was turned to a paste with 0.5 mL of sesame oil
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Lot/batch no. (if required): no data
- Purity: no data - Duration of treatment / exposure:
- 4 h
- Observation period:
- after 60 min, 24, 48 and 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: approx. 20 cm² on the right flank
- % coverage: no data
- Type of wrap if used: the sample was placed under a pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape, wrapped with rubberized cloth
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with a pad soaked in distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- see table below
- Other effects:
- none
Any other information on results incl. tables
Table: 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: 4 |
|
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0/ |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
Reversibility*) |
- |
- |
Average time (unit) for reversion |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions the test material Bis(C12-C13)alkyl-2-hydroxybutandioate can be considered as non-irritant.
- Executive summary:
The test was performed by means of a single dose application of the test material Bis(C12-C13)alkyl-2-hydroxybutandioate on the skin of 6 albino male rabbits according to OECD Guideline 404.
The test material was applied to the skin of 6 rabbits at a dose of 500 mg in 0.5 mL sesame seed oil/rabbit for 4 hours. The animals were observed after the removal of the bandages and after 24, 48 and 72 hours for signs of erythema or oedema. During the study no erythema nor oedema were detected.
Under the test conditions the test material Bis(C12-C13)alkyl-2-hydroxybutandioate can be considered non-irritant for the skin.
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