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Diss Factsheets
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EC number: 924-055-3 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Sept 1999 - 10 Sept 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study without deviations from guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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:
- ISOPHEN - 035
- IUPAC Name:
- ISOPHEN - 035
- Details on test material:
- - Name of test material (as cited in study report): KLEMMFILZ ISOPHEN - 035 ( ISOPHEN - 035)
Yellow, solid substance - fibre
Lasting stability
Batch no: C 27.08.99 IV
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding and Reasearch Center A/S Ejby, DK-4623
- Age at study initiation: no data
- Weight at study initiation: 2,3-2,7 kg
- Housing: Individually in PPO cage. floor area: 2576 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: ad least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: sesame oil
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the fibre test article
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after termination of exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: 16-layer gauze patches
REMOVAL OF TEST SUBSTANCE
- Washing (if done): mild soap and luke warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and Escar formation scale:
no erythema: 0
Very light eryhema (barely perceptible): 1
well-defined erythema: 2
Moderate erythema: 3
Severe erythema:4
Oedema formation scale:
no oedema: 0
Very light oedema (barely perceptible): 1
well-defined oedema: 2 (edges of area well-defined by definite raising)
Moderate erythema: 3 (raised approx. 1 mm)
Severe erythema:4 (raised more than 1 mm, extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
Any other information on results incl. tables
|
Erythema formation observed at hours # |
Individual mean scores* |
Oedema formation observed at hours # |
Individual mean scores* |
||||||||
|
Rabbit no |
Weight kg |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
||
PL |
1442 |
2.2 |
0 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0.00 |
PR |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
PL |
1349 |
2.3 |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
PR |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
PL |
1353 |
2.5 |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
PR |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
PL: Posterior left test field
PR: Posterior right test field
# After termination of exposure
*Only the scores from the readings after 24, 48, and 72 hours are incuded in the calculation of the individual values.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the EC-standards as published in Council Directive 67/548/EEC and Regulation (EC) 1272/2008 the test samples examined are not irritating to rabbit skin in vivo. Thus, it is concluded that FMMVF fibres are not irritating to human skin.
- Executive summary:
Three female albino rabbits were exposed to 0.5 g of the test material under a semi-occlusive bandage for 4 hours and subsequently monitored at the intervals of 1, 24, 48, 72 hours as well as 7 and 14 days after termination of exposure. The mean score for erythema was 0.67 and mean score for oedema was 0. Hence the material shall not be classified as skin irritating according to Council Directive 67/548/EEC and Regulation (EC) 1272/2008. It is concluded that MMVF fibres are not irritating to human skin.
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