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EC number: 604-471-9 | CAS number: 14543-49-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guidelines for testing of chemicals No.404 and EU method B.4 No.L251.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Purity: 99.2%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Females, approx. 14 weeks old and weighing 2416-2876g at the start of treatment, sourced from Broekman Institute, Someren, The Netherlands.
Conditions: Standard Laboratory Conditions. Air-conditioned with 7.5-15 air changes per hour and hourly monitored environment with temperature 20 ± 3°C, relative humidity 30-70 %, 12 hours artificial fluorescent light / 12 hours dark.
Accommodation: Individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
Diet: Pelleted standard LKK-20 rabbit maintenance diet (Hope Farms, Woerden, The Netherlands) approx. 100 g per day.
Water: Free access to tap-water diluted with decalcified water.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5mL
- Duration of treatment / exposure:
- 4h
- Observation period:
- 14days
- Number of animals:
- 3
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper , exposing an area of approximately 100 square centimeters (10 cm x 10 cm).
Prior to test article administration, the animals were physically examined and the skin found to be intact and normal.
On test day 1, 0.5 ml of the test article was applied to the intact skin of the shaved area, using a surgical gauze patch 2x3 cm mounted on Micropore tape (3M, St. Paul, U.S.A.). The dressing was wrapped around the abdomen and anchored with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).
Duration of exposure was 4 hours.
Four hours after the application, the dressing was removed and the remaining test substance was removed using a dry tissue and subsequently a tissue moistened with tapwater.
The skin reactions were assessed at approximately 55 minutes, 24, 48 and 72 hours and at 7 and 14 days after the removal o f the dressings and test article. In order to facilitate the scoring, the skin area concerned of all animals was shaved again a t least 3 hours before the observation on days 2, 8 and 15.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 14d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: new skin formation in 2/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7d
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 14d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: new skin formation in 2/3 animals
- Irritant / corrosive response data:
- The observed skin irritation consisted of very slight to well-defined erythema and slight oedema. The irritation was reversible within 14 days after exposure.
No corrosive effect was evident on the skin. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The primary irritation index of 3.5 which is moderately irritant when applied to the intact rabbit skin. The observed skin irritation consisted of very slight to well defined erythema and slight oedema. The irritation was reversible within 14 days after exposure. No corrosion effect was evident on the skin.
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