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EC number: 700-571-2 | CAS number: -
- 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 / corrosion, other
- Remarks:
- in vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 hr
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK Department of Health, 21 November 2005
Test material
- Reference substance name:
- Renewable hydrocarbons (diesel type fraction)
- EC Number:
- 700-571-2
- Cas Number:
- 928771-01-1
- Molecular formula:
- C10-20H22-42
- IUPAC Name:
- Renewable hydrocarbons (diesel type fraction)
- Details on test material:
- Name of test material (as cited in study report): NExBTL Biodiesel
- Description: Clear colourless liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: accredited supplier
- Age at study initiation: 12-20 wk
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually housed
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 (lights on 0600-1800 hr)
IN-LIFE DATES: From: 23 May 2007 To: 26 May 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml (neat)
- Duration of treatment / exposure:
- 4 hr
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- Skin on the dorsal/flank was clipped free of hair on the day before treatment. On the day of treatment 0.5 ml neat test substance applied to an area of clipped skin, covered with 2.5 cm x 2.5 cm piece of gauze secured with surgical tape and the trunk of animal wrapped with elasticated corset for the duration of the exposure. The wrappings were removed after 4 hr and test site wiped with cotton wool moistened with distilled water. The treatment site was examined for local reactions 24, 48 and 72 hr after patch removal and any dermal responses recorded using Draize criteria.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 2
- Max. score:
- 2
- Remarks on result:
- other: resent in all 3 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hr
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- other: Present in all 3 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hr
- Score:
- 0.33
- Max. score:
- 1
- Remarks on result:
- other: Single animal affected
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hr
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Barely perceptible desquamation present in 1 animal
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- other: Present in all 3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 hr
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating to skin
- Executive summary:
Skin irritation potential was evaluated in a GLP-compliant guideline study (method B4 of directive 2004/73/EC) using 3 male New Zealand White rabbits. The test sample (0.5 ml) was applied undiluted to an area of clipped dorsal skin (approx. 2.5cm x 2.5 cm) and covered with a semi-occlusive dressing for 4 hr and the animals housed individually. The wrappings were then removed, the test skin wiped clean with cotton wool moistened with distilled water and reactions at the test site recorded (Draize criteria) at 1, 24, 48 and 72 hr after patch removal. Well defined erythema (grade 2) and very slight oedema (grade 1) was present 1 hr following patch removal, decreasing to very slight erythema (grade 1; no oedema) at 24 hr, resolving in two animals by 48 hr and in the third by 72 hr. Barely perceptible desquamation of the test site was also visible in one animal only at 72 hr. Under the conditions of the test NExBTL renewable diesel caused mild, fully reversible skin irritation.
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