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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 232-983-9 | CAS number: 9075-68-7
- 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:
- March 28 - August 3, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICH S4A - Single dose toxicity
- Version / remarks:
- 1991
- Deviations:
- no
- Principles of method if other than guideline:
- A limit acute oral toxicity test was performed. A preliminary group of one male and one female rat received a single dose of the undiluted test material in a volume of 20 mL/kg body weight. These animals were observed for 7 days and since the dosing was well tolerated, additionally five males and females were dosed at 20 mL/kg body weight followed by a 14 days observation period, where clinical conditions and bodyweight were followed. At the end, the animals were killed and macroscopic examination was performed.
- GLP compliance:
- yes
- Test type:
- other: ICH S4A - Single dose toxicity, 1991
- Limit test:
- yes
Test material
- Reference substance name:
- Pullulanase
- EC Number:
- 232-983-9
- EC Name:
- Pullulanase
- Cas Number:
- 9075-68-7
- Molecular formula:
- not available
- IUPAC Name:
- Pullulanase
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- - Substance type: UVCB
- Physical state: Liquid
- Lot/batch No.: PPY 25645
- Expiration date of the lot/batch: 09 March 2016
- Stability under test conditions: The test material and dilutions are stable for at least 24 hours at 5 degrees of C and at room temperature
- Storage condition of test material: Approximately minus 20 degrees of Celcius. Thawed and refrozen on no more than one occasion.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD® (SD)IGS BR rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River (UK) Ltd
- Age: 35 to 41 days at the day of treatment
- Fasting period before dosing: overnight fasting prior to dosing
- Housing: Barriered rodent facility with control of temperature and humidity. Five of the same sex in cages made of a polycarbonate body and floor with a stainless steel mesh lid. Lignocel type 3/4 wood shavings were provided as bedding. Aspen chew block for environmental enrichment.
- Weight at the end of the acclimatisation period: Males 149 - 168 g, females 116 -130 g.
- Diet: Pelleted standard rodent diet (Rat and Mouse No. 1 Maintenance Diet) ad libitum
- Water: Water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23 °C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Undiluted test material
- Doses:
- Dose volume was 20 mL/kg bodyweight (equivalent to 2.012 g TOS/kg bodyweight, 31230 PUN-RPA/kg)
- 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: Observations for clinical signs of effect: soon after dosing, at least twice during the first hour after dosing (approximately 30 minutes apart) and subsequently at approximately one-hour intervals for the remainder of day 1. On subsequent days animals were inspected at least twice daily. Weighing was done immediately before dosing at day 1, and on day 8 and day 15.
- Necropsy of survivors performed: yes - Statistics:
- No
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: Fixed dose method - no effects were seen
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: Fixed dose method - no effects were seen
- Effect level:
- > 2 012 mg/kg bw
- Based on:
- other: Total Organic Solids (TOS)
- Mortality:
- No animals died during the study.
- Clinical signs:
- No animals died and no sign of toxicity or ill health was seen at the routine physical examination.
- Body weight:
- No effect was observed on the body weights.
- Gross pathology:
- Effects on organs:
Macroscopic examination of animals killed on Day 15 of the observation period did not reveal any treatment-related findings. - Other findings:
- Punctate clear cysts were found on the left kidney of female No. 11. This is a common finding in laboratory rodents and was considered to be unrelated to a single administration of Pullulanase, PPY 25645.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of toxicity were observed among the rats treated with a single oral dose of 2012 mg total organic solids/kg, which was the highest possible dose at dose volume 20 mL/kg, using the undiluted test item.
- Executive summary:
The study was conducted as a limit test in accordance with the International Conference on Harmonisation (ICH) S4A – Single dose toxicity guidance, which is principally similar to the OECD Guideline No 420, "Acute Oral Toxicity - Fixed dose Method".
The test item was supplied as a brown liquid. The dose volume administered was 20 mL of the undiluted test material per kg body weight, corresponding to a dosage of 2.012 g Total Organic Solids (TOS)/kg bw. A group of five male and five female rats received the test material by a single oral administration (gavage). The animals were subjected to clinical observations daily for a fourteen day observation period and at termination of the study, gross necropsy of all animals was carried out.
No clinical effects were observed and the overall body weight gain during the study was considered to be normal. The post-mortem inspection revealed no abnormalities.
In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 20 mL of the undiluted test material per kg body weight (= 2.012 g TOS/kg bw).
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.