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EC number: 618-333-0 | CAS number: 9001-85-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 23, 2013 - November 21, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted 17 December 2001.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Active enzyme protein of lysophospholipase ( (EC no.618-333-0, CAS no. 9001-85-8, EC name Lysophospholipase, Enzyme class no 3.1.1.5 )
- Molecular formula:
- Not available
- IUPAC Name:
- Active enzyme protein of lysophospholipase ( (EC no.618-333-0, CAS no. 9001-85-8, EC name Lysophospholipase, Enzyme class no 3.1.1.5 )
- 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:
- 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:
- 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:
- 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:
- - Lot/batch No.: PPW35424
- Expiration date of the lot/batch: 01 July 2023
- Stability under test conditions: The test material is stable for at least 24 hours at room temperature
- Storage condition of test material: Frozen (-20°C)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- other: CD (Crl:CD ‘SD’) albino rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 221 to 238 g
- Fasting period before study: overnight fasting prior to dosing
- Housing: Barriered rodent facility with control of temperature, humidity and lighting. The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Softwood bark-free fibre were provided as bedding. Aspen chew block and plastic shelter for environmental enrichment.
- Diet: standard rodent diet (Rat and Mouse No. 1 Maintenance Diet) ad libitum
- 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
IN-LIFE DATES: From: 2013-10-01 To: 2013-10-15
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Undiluted test material for the top dose.
- Doses:
- Dose volume was 16 mL/kg bodyweight (equivalent to 2085 g TOS/kg bodyweight).
- No. of animals per sex per dose:
- 6 (female only)
- 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, and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded. - Statistics:
- No
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 085 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.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of toxicity were observed in any of the rats treated with a single oral dose of 2085 mg total organic solids/kg body weight for a period of 14 days.
- Executive summary:
The objective of the study was to assess the acute toxicity of lysophospholipase when administered by gavage as a single oral dose to one group six female rats followed by an observation period of 14 days.
The study was conducted in accordance with the OECD Guideline No 423, “Acute Oral Toxicity – Acute Toxic Class method”. The design of the limit test was used. The test item was supplied as a liquid ready to use. The dose volume administered was 2085 mg/kg body weight, based on the Total Organic Solids (TOS) content of the test substance.
A group of three fasted female rats received a single oral gavage dose of the test substance. As results at this dose level indicated the acute lethal oral dose of the test substance to be greater than 2085 mg TOS/kg body weight, in compliance with the study guidelines, a further group of three fasted females was similarly dosed at 2085 mg TOS/kg body weight to complete the study.
There were no deaths during the study. There were no clinical signs of reaction to treatment throughout the study. All animals were considered to have achieved satisfactory body weight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
In conclusion, the acute median lethal oral dose (LD50) to rats of lysophospholipase, batch PPW35424 was demonstrated to be greater than 2085 mg TOS/kg body weight.
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