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EC number: 232-615-7 | CAS number: 9001-57-4
- 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:
- 11 - 22 February 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- yes
- Remarks:
- occlusive dressing used: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal, this coverage
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin, Berlin, Germany
Test material
- Reference substance name:
- Xylanase, endo-1,4-
- EC Number:
- 232-800-2
- EC Name:
- Xylanase, endo-1,4-
- Cas Number:
- 9025-57-4
- Molecular formula:
- Not applicable, see remarks.
- IUPAC Name:
- endo-1,4-beta-xylanase
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxicology department Rallis Research Centre, Bangalore, India
- Age at study initiation: 5 - 6 months
- Weight at study initiation: 2.16 - 2.31 kg
- Housing: individually in fibre board cages (size: L 77 x B 54 x H 63 cm) with steam sterilized paddy husk bedding
- Diet: Rabbit feed (Nav Maharashtra Chakan Oil Mills Ltd., Maharashtra, India), ad libitum
- Water: Deep bore-well water, ad libitum
- Acclimation period: 7 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 Feb 2002 To: 18 Feb 2002
Test system
- Type of coverage:
- other: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
NEGATIVE CONTROL
- bare cotton gauze of similar size without any test item applied - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left side of the dorso-lateral thoracic surface, appriximately 6 cm² (2 x 3 cm)
- Type of wrap if used: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing: flushed with deionised water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize scroing system
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
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No local reactions (erythema, edema) indicative for skin irritation have been observed 1 h after patch removal in any animal.
- Other effects:
- - Other adverse local effects:
There were no skin reactions.
- Other adverse systemic effects: There were no pre-termial deaths, no effects on body weight and no signs of toxicity observed. Also at necropsy no abnormaility was detected.
Any other information on results incl. tables
Table 1: Test for Irritant Effects on the Skin (Expos.: 4 h) Draize grade
animal number |
1 h |
24 h |
48 h |
72 h |
||||
|
erythema |
edema |
erythema |
edema |
erythema |
edema |
erythema |
edema |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- A reliable study conducted in accordance with OECD 404 and GLP, determined the test material to be non-irritating to the skin of rabbits. No edema or erythema were observed at any time point. CLP: not classified
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