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EC number: 232-619-9 | CAS number: 9001-62-1
- 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:
- From February 03, 1997 to August 08, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- and EEC directive 92/69/EEC.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
- Cas Number:
- 9001-62-1
- Molecular formula:
- Not applicable, see remarks
- IUPAC Name:
- Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
- 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. See remarks.
- 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. See remarks.
- 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. See remarks.
- 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.: PPW 5756
- Expiration date of the lot/batch: 02 December 2006
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:
- - Source: Møllegaard Breeder, Ejby, Denmark
- Fasting period before dosing: overnight fasting prior to dosing
- Housing: Five of the same sex in transparent plastic boxes (Type IV 590 MAK overall dimensions 59 x 38 x 20 cm) with wire grid tops and aspen wood chips bedding. In a barrier maintained animal room with control of temperature and humidity
- Weight at the end of the akklimatization period: Males 154-156 g, females 124-131 g.
- Diet: Altromin rat/mouse Breeding 1320 diet pellets ad libitum
- Water: Water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 February 1997 to 26 Februay 1997
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 bw, corresponding to a dose of 2740 mg enzyme concentrate dry matter/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: Observations for clinical signs of effect: before dosing, twice after dosing (day 1) and thereafter once per day for the following 14 days. Weighing immediately before dosing at day 1, day 8 and Day 15.
- Necropsy of survivors performed: yes - Statistics:
- No
Results and discussion
Effect levelsopen allclose all
- 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:
- > 2 740 mg/kg bw
- Based on:
- other: Enzyme concentrate dry matter
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: No clinical signs were observed in the dose group.
- Gross pathology:
- Effects on organs: No macroscopic alterations were observed at the terminal post mortem examination.
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 2740 mg enzyme concentrate dry matter/kg bw (equivalent to 1940 mg active enzyme protein/kg bw), which was the highest possible dose at dose volume 20 mL/kg, using the undiluted test item.
- Executive summary:
The study was conducted in accordance with the OECD Guideline No 420, "Acute Oral Toxicity - Fixed dose Method" and EEC directive 92/69/EEC.
The test item was supplied as a brown liquid ready to use. The dose volume administered was 20 mL of the undiluted test material per kg body weight, corresponding to a dosage of
2.74 g enzyme concentrate dry matter/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 2740 mg enzyme concentrate dry matter/kg bw (equivalent to 1940 mg active enzyme protein/kg bw).
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