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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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed before formal guidelines but according to best practice at that time, and according to GLP .
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study was perfermed before any formal guidelines but according to best practice at that time.
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
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:
- solid: particulate/powder
- Remarks:
- powder
- Details on test material:
- - Lot/batch No.: PPW 1798
- Expiration date of the lot/batch: December 1996
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Manston, Kent, UK.
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 162-219 g
- Housing: 2 per cage.
- Diet (e.g. ad libitum): Rat and Mouse Breeder Diet No. 3 SQC Expanded (ground) ad libitum
- Water : domestic water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%): 55% ± 10%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Diet without test substance
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet: Fresh diet batches were prepared weekly during the study, each dose level being prepared independently.
- Mixing appropriate amounts of lipase with the rat diet to following dose levels, 0, 2, 5 and 10 % in the diet. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples were removed from each mixed batch of diet and despatched to the Sponsor for analysis of enzyme activity in lipase units/g.
- Details on mating procedure:
- 108 female rats arrived timed-mated on day 1 of gestation at the research lab.
- Duration of treatment / exposure:
- 12 days (day 6 - day 17 of gestation).
- Frequency of treatment:
- The diet contained a constant concentration of test material and was available ad libitum.
- Duration of test:
- The animals had access to treated diet from day 6 - day 17 of gestation (day 0 = day of verification of copulatory plug in situ).
- No. of animals per sex per dose:
- 27 mated females
- Control animals:
- yes, plain diet
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: During each day
BODY WEIGHT: Yes, at day 1, 6, 9, 13, 17 and 20 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each cage determined daily
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No - Ovaries and uterine content:
- On day 20, the animals were killed by nitrogen asphyxiation. The reproductive tract was dissected out, weighed and then examined.
- Fetal examinations:
- - External examinations: Yes all per litter
- Soft tissue examinations: Yes, 1/3 of the foetuses by free-hand sectioning (Wilson), while the other 2/3 were fixed for gross visceral abnormalities.
- Skeletal examinations: Yes, 2/3 of the foetuses
- Head examinations: Yes, 2/3 of the foetuses
Number of implants were recorded, if they were alive or dead (late vs early) - Statistics:
- Body weight and foetal weight data were subjected to analysis of variance, using the Normal linear model for a one-way classification. Treatments were then compared using Dunnett’s t test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects: Yes
Details on maternal toxic effects: Slight reductions in maternal body weight gain and food consumption occurred at the 10% lipase dose level only
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: Yes
Details on embryotoxic / teratogenic effects: At 5% and 10% lipase in the diet, there was a very slight reduction in foetal weight, together with some other evidence of slight immaturity amongst parameters of skeletal ossification state and in growth of the viscera of a small number of fetuses.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- other: >= 2% lipase by weight in the diet
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Applicant's summary and conclusion
- Conclusions:
- Maternal effect of treatment in this study were slight reductions in weight gain and food consumption at 10% lipase in the diet.
At 5% and 10% lipase in the diet, there was a very slight reduction in foetal weight, together with some other evidence of slight immaturity amongst parameters of skeletal ossification state and in growth of the viscera of a small number of fetuses.
It was concluded that, under the conditions of this study, dose levels of 5% and 10% lipase by weight in the diet caused slight growth retardation of fetuses, while slight maternal toxicity was confined to the 10% lipase dose level.
No significant effect was considered to have occurred at a dose level of 2% lipase by weight in the diet. No teratogenic potential of lipase was demonstrated at any dose level up to 10% lipase by weight in the diet. - Executive summary:
Lipase, batch PPW 1798 was used for teratogenicity testing in rats.
Mated Sprague-Dawley rats were randomized into 3 treatment groups and one control group, each group containing 27 animals. These animals were exposed continuously to test diets from Day 6 to Day 17 of gestation, where Day 0 was the day of verification of mating by detection of a copulatory plug in situ. Dose levels applied were as follows:
% lipase by Weight in the Diet
Control
Low dose
Intermediate dose
High dose
0
2
5
10
It was concluded that, under the conditions of this study, dose levels of 5% and 10% lipase in the diet caused slight growth retardation of fetuses, while slight reductions in maternal body weight gain and food consumption occurred at the 10% lipase dose level only.
No significant effect was considered to have occurred at the 2% lipase level.
No teratogenic potential of lipase was demonstrated at any of the dose levels used.
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