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EC number: 232-766-9 | CAS number: 9015-75-2
- 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:
- February 22, 1999 to May 5, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC directive 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Lyase, pectate
- EC Number:
- 232-766-9
- EC Name:
- Lyase, pectate
- Cas Number:
- 9015-75-2
- Molecular formula:
- Not available
- IUPAC Name:
- Pectate lyase IUBMB 4.2.2.2
- 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:
- - Lot/batch No.: PPE 6345
- Expiration date of the lot/batch: 2008-11-30
- Stability under test conditions: Stability at ambient temperature >4 hours
- Storage condition of test material: Stored below minus 18 degrees of C in the dark.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Avlslaboratorium, Ejby, DK
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Not specified
- Fasting period before dosing: 20 hours prior to dosing and until 1 hour after the last dosing procedure.
- Housing: Barriered rodent facility with control of temperature and humidity. Five of the same sex per cage in transparent plastic boxes with wire grid tops with aspen wood chips as bedding.
- Weight at the end of the acclimatisation period: Males 172-184 g, females 137-147 g.
- Diet: Altromin rat/mouse Breeding 1320 diet pellets ad libitum
- Water: Tap water added citric acid to pH 2-3 ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 30-70%
- Air changes/hr: 8-12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1999-02-26 To: 1992-03-12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Undiluted test material.
- Doses:
- Dose volume was 24 mL/kg bodyweight. The animals were dosed twice with 12 mL/kg bodyweight within 2 hours.
24 mL/kg bodyweight is equivalent to 2064 mg TOS/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 symptoms after the first and second dosing procedure and 2 hours after the last dosing. Thereafter clinical observations were carried out once a day for the following 14 days. Animals were weighed on day 1 (before dosing) and on day 8 and before necropsy on day 15.
- Necropsy of survivors performed: yes - Statistics:
- No
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 24 mL/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 064 mg/kg bw
- Based on:
- other: Total Organic Solids (TOS)
- Mortality:
- No animals died during the observation period.
- Clinical signs:
- other: No clinical symptoms were seen during the observation period.
- 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 for pectate lyase tested on rats treated with a single oral dose of 2064 mg total organic solids/kg, which was the highest possible dose at dose volume 24 mL/kg, using the undiluted test item.
- Executive summary:
The objective of the study was to assess the acute toxicity of pectate lyase when administered by gavage as a single oral dose to one group of five male and five female rats followed by an observation period of 14 days.
The study was conducted in accordance with the OECD Guideline No 401, 1987 “Acute Oral Toxicity”. The limit test was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 2x12 mL/kg bodyweight of the undiluted test material.
No clinical signs 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 2064 mg Total Organic Solids (TOS)/kg.
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