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Diss Factsheets
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EC number: 240-198-8 | CAS number: 16052-06-5
- 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:
- October 01, 2002 - May 19,2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- yes
- Remarks:
- The body weight at the start of the study was outside the target range of 2.50-5.50 kg. This deviation did not influence the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid
- EC Number:
- 230-907-9
- EC Name:
- 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid
- Cas Number:
- 7365-45-9
- Molecular formula:
- C8H18N2O4S
- IUPAC Name:
- 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: ~15 weeks
- Weight at study initiation: 2.05 kg (range from 2.00 to 2.13)
- Housing: separately in special rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 19
- Humidity (%): 45 to 72
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: day 1 To: day 8
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of the test material mixed with some drops of Aqua pro injectione to ensure good contact
- Duration of treatment / exposure:
- 4 hour period under semiocclusive conditions
- Observation period:
- 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100 %
- Type of wrap: Fixomull® stretch, Beiersdorf
REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: after 4 hours
SCORING SYSTEM: Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed at the treated areas.
- Other effects:
- - Other adverse systemic effects: No signs of clinical toxicity were detected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected. The test material can be regarded as non irritant.
- Executive summary:
The test performed in accordance with OECD TG 404. 0.5 g of the test material mixed with some drops aqua pro injectione were spread onto 6 cm² patches and applied to the intact skin of 3 previously shaven rabbits (females) for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.
Under the conditions of the present study, no signs of toxicity were seen.
Evaluation of each animal:
Mean score (24h, 48h, 72h)
Maximum value (24h, 48h, or, 72h)
Animal No.
31
32
33
31
32
33
Erythema
0.0
0.0
0.0
0
0
0
Edema
0.0
0.0
0.0
0
0
0
No skin irritating potential could be detected. The test material should not be classified as a skin irritant.
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