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EC number: 232-802-3 | CAS number: 9025-67-6
- 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
Endpoint summary
Administrative data
Description of key information
Inulinase was tested in rabbits for skin and eye irritation.
- Under the test conditions employed, Novozym 230 had a primary irritation score of 0.0 and was classified as a "non irritant" to skin.
- Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury, and cannot be classified under the GHS criteria.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19-01-1982 to 22-03-1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Code of Federal Regulations 1979, title 16, § 1500.41 with a few modifications.
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations 1979, title 16, § 1500.41 with a few modifications.
- Deviations:
- no
- Remarks:
- A few modifications.
- Principles of method if other than guideline:
- Instead of 24 hours the rabbits were only exposed to the test substance for 4 hours and readings were made 1, 24, 48 and 72 hours after the exposure had ended .
- GLP compliance:
- no
- Remarks:
- Only assessed by Quality Assurance.
- Species:
- rabbit
- Strain:
- other: Albino rabbits, Danish Landstrain.
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by novozymes A/S (previously known as Novo Industri A/S)
- Age at study initiation: Not stated.
- Weight at study initiation: 2.5-3.1 kg
- Housing: Galvanized steel cages with mesh floors and automatic watering in a room with the relative humidity.
- Diet (e.g. ad libitum): Ewos Brood Stock Feed for Rabbits and Guinea Pigs.
- Water (e.g. ad libitum): Automatic watering in a room.
IN-LIFE DATES: From: 1982-01-19 To: 1982-01-22 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- and part abraded
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): used as is (86.6% TOS) - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 1, 24, 48 and 72 hours.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch x 1 inch
- % coverage: 100%
- Type of wrap if used: Surgical gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not stated
- Time after start of exposure: After 4 hours of exposure, the coat, the patches and the test substance were removed and the resulting reactions were evaluated 1 hour later.
SCORING SYSTEM:
- Method of calculation: A primary irritation score was calculated according to 16 CFR 1500.41, 1979 by means of the 1, 24, 48 and 72 hours. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions employed, Novozym 230 had a primary irritation score of 0.0 and was classified as a "non irritant" to skin.
- Executive summary:
A test for primary skin irritation in rabbits was carried out with Novozym 230 (batch PPZ1281) according to the Code of Federal Regulations 1979, title 16, § 1500.41 with a few modifications. Instead of 24 hours the rabbits were only exposed to the test substance for 4 hours and readings were made 1, 24, 48 and 72 hours after the exposure had ended.
Under the test conditions employed, Novozym 230 had a primary irritation score of 0.0 and was classified as a "non irritant" to skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26-01-1982 to 22-03-1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Code of Federal Regulations, title 16, § 1500.42
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, title 16, § 1500.42
- Deviations:
- yes
- Remarks:
- A few modifications.
- GLP compliance:
- no
- Remarks:
- Only inspection from quality assurance.
- Species:
- rabbit
- Strain:
- other: Albino rabbits, Danish Landstrain
- Remarks:
- and part abraded.
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by novozymes A/S (previously known as Novo Industri A/S)
- Age at study initiation: Not stated.
- Weight at study initiation: 2.8-3.1 kg
- Housing: Galvanized steel cages with mesh floors and automatic watering in a room with the relative humidity. - Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The chicken eye cornea was treated with 30 µL.
- Concentration (if solution): undiluted test sample, 86.6% TOS. - Duration of treatment / exposure:
- Eyelids were held together for about one second and then released.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours and again 7 days.
- Number of animals or in vitro replicates:
- 6 animals, 3 female and 3 males.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Except for the examination at 1 hour, one drop of 1% fluorescein sodium was used. The excess of fluorescein was flushed out with 0.9% sodium chloride solution.
- Time after start of exposure: The exposure period was 1 second. The eyes were examined at 1, 24, 48 and 72 hours and again 7 days.
SCORING SYSTEM: Code of Federal Regulations, title 16, § 1500.42
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.167
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- ulceration
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- ulceration
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- ulceration
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury, and cannot be classified under the GHS criteria.
- Executive summary:
An eye irritation test on 6 albino rabbits carried out with Novozym 230 (batch PPZ1281) according to the Code of Federal Regulations, title 16, § 1500.42.
0.06 g of the test substance corresponding to the volume 0.1 mL was placed in the left eye of each rabbit by gently pulling the lower lid away from the eye ball, and the test substance was carefully introduced into
the resulting cup. The lids were then gently held together for one second. The right eye, remaining untreated, served as a control.
The treatments resulted in slight conjunctival redness in two of the rabbits until 24 hours. This effect was reversible within 48 hours.
Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Not classified.
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.
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