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Diss Factsheets
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EC number: 942-444-6 | 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: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 1996/04/11 to 1996/06/13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted according to OECD guideline N°404 in compliance with GLP. No test substance rinsed off after 4-hour exposure as no residual test substance noted at dressing removal Substance analytical certificate available Substance identification: information available from supplier for commercial name (Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No test substance rinsed off after 4-hour exposure
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Guideline study
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics
- EC Number:
- 927-632-8
- IUPAC Name:
- Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics
- Reference substance name:
- EDC 95-08
- IUPAC Name:
- EDC 95-08
- Details on test material:
- - Name of test material (as cited in study report): EDC 95-08
- Substance type: petroleum product, UVCB
- Composition of test material, percentage of components: Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics
- Substance state: colourless liquid
- Analytical purity: 100% Commercial product
- Storage condition of test material: at room temperature
- Lot/batch No.: 8865
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour of filtered.
- Photoperiod (hrs dark / hrs light): 12 h/ 12h
IN-LIFE DATES: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Electric clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reaction assessed at 1, 24, 48 and 72 hours after exposure (after the removal of the patch)
- Number of animals:
- 1 animal in the first assay (to assess the irritancy of the substance) and then two remaining animals.
- Details on study design:
- TEST SITE
- Area of exposure: over a 2.5 cm² (approximately 6 cm²)
- % coverage: no data
- Type of wrap if used: a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No test substance rinsed off after 4-hour exposure. No residual test substance noted at removal of the dressing
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- See Table I
- In one animal, no skin reactions were observed
- Very slight erythema was noted in the two other rabbits, at the one-hour and 24 hours readings
Mean scores over 24, 48 and 72 hours for individual animals were 0.0, 0.3 and 0.3 for erythema and 0.0 for oedema. - Other effects:
- None
Any other information on results incl. tables
Table I: 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 |
|
24 h |
0/1/1 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.0-0.3-0.3 |
0-0-0 |
Reversibility* |
c |
- |
Average time (unit) for reversion |
Within 48 h |
- |
* Reversibility: c. = completely reversible
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, EDC 95-08 is not classified as skin irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
- Executive summary:
In a primary dermal irritation study conducted according to OECD guideline N°404 in compliance with GLP, three young adult New Zealand White rabbits were dermally exposed to 0.5 mL of EDC 95-08. Test sites were covered with a semi-occlusive dressing for 4 hours. The skin reactions were assessed at 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times for individual animals: 24, 48 and 72 hours after patch removal, for each animal separately.
The mean individual scores over 24, 48 and 72 hours were 0.0, 0.3 and 0.3 for erythema and 0.0 for oedema.
Based upon the directive 67/548/EEC and the CLP Regulation 1272/2008, EDC 95-08 is not considered as irritating to the rabbit skin.
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