Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 March - 6 April 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- yes
- Remarks:
- animal number and schedule of administration: 5 animals per sex were used (Limit test) and a preliminary test was conducted using 2 females administered doses of 400 or 800 mg/kg bw/day
- GLP compliance:
- yes
- Limit test:
- yes
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:
- rat
- Strain:
- other: CD strain (remote Sprague-Dawley origin)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK), Margate, England
- Age at study initiation: 5 weeks
- Weight at study initiation: 109 - 136 g (males), 99 - 117 g (females)
- Fasting period before study: overnight
- Housing: 5 animals per sex in stainless steel grid cages (RS Biotech, Northants, England)
- Diet: complete pelleted rodent diet (RM 1 (E) SQC,Special Diets Services Limited, Witham, England), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- purifed (obtained by the reverse osmosis of water)
- Details on oral exposure:
- VEHICLE
- purified water (obtained by the reverse osmosis of water)
- Concentration in vehicle: the test material was prepared at the appropriate concentration in purified water
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations and inspections for morbidity / mortality were performed two times within the first hours after test substance application and two forther ones at Day 1. From Day 2 onwards animals were inspected twice daily and bodyweights were determined on the the day before dosing and on Day 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: larger organs were sectioned and gastrointestinal tract was opened at intervals for examination of the mucosal surfaces
Results and discussion
- Preliminary study:
- A preliminary study was carried out using two female rats given an oral administration of [test substance] at a dosages of 400 or 800 mg/kg bw, at a constant volume-dosage of 20 mL/kg bw in purified water. In this study no deaths occurred.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths observed during the study.
- Clinical signs:
- There were no clinical signs observed.
- Body weight:
- The animals showed expected gains in body weight over the observation period.
- Gross pathology:
- No abnormalities were noted at the macroscopic examination at study termination.
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:
- In this acute oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was determined. CLP: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.