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EC number: 232-979-7 | CAS number: 9074-98-0
- 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
The acute oral LD50 of four close analogues of the test substance was determined to be ≥ 2000 mg/kg bw.
The acute inhalation LC50 (4h) of a close analogue of the test substance was determined to be ≥ 2.25 mg/L air, which was the highest attainable concentration.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to the read-across justification attached to section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Based on read-across from Cellulase 2000L and endo-1,3-beta-glucanase
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Based on read-across from Hostazym C
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Remarks on result:
- other: Based or read-across from VR002 Pyrolase HT Cellulase
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to the read-across justification attached to section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 3 830 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Based on read-across from endo-1,3-beta-glucanase
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 2.25 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Based on read-across from Cellulase 2000L
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 2 250 mg/m³ air
- Quality of whole database:
- Technically attainable concentrations were below the highest classification limit of the CLP Regulation.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Since no acute toxicity studies are available for the substance itself, read-across is made to close structural analogues of the substance.
Acute toxicity: oral
No acute oral study was available for the test substance itself. A very close analogue of the test substance, consisting of a complex substance in which the major enzyme activity is from the cellulase, which is basically the same enzyme as the test substance (Cellulase 2000 L), was tested in an OECD TG 401 acute toxicity limit test (Dupont, 2015). Five male and five female Sprague-Dawley rats were exposure orally to 2000 mg/kg bw/d of the test material. They were observed for 15 days. No mortality, nor overt signs of toxicity were noted throughout the observation period. All animals achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The LD50 was determined to be ≥2000 mg/kg bw.
Another study (Calvert Laboratories, 2013) assessed the acute oral toxicity of the structural analogue (source substance) VR002 Pyrolase HT Cellulase, according to OECD 425. Female rats were exposed via the oral route (by gavage) to a single dose (1000 mg/kg) of the test item for 14 days. Clinical signs, weight changes, mortality were observed. No adverse effects were observed and the LD50 was determined to be > 1000 mg/kg bw/day.
An oral toxicity study was carried out with Hostazym C (endo-1,4-beta-glucanase), in compliance with OECD Guideline 401 (EFSA, 2013). Five male and five female rats (strain Charles River Crl:CD BR) were given a single dose of 5 g/kg bw in distilled water by gavage. No treatment-related effect on body weight, food consumption or water consumption and no abnormal behaviour were reported during the observation period (14 days). Necropsy of all animals at the end of the study revealed no findings attributable to treatment with the enzyme.
Acute toxicity: inhalation
No acute inhalation study was available for the test substance itself. A very close analogue of the test substance, consisting of a complex substance in which the major enzyme activity is from the test substance (Cellulase 2000 L), was tested in an OECD TG 403 acute toxicity limit test (Dupont, 2015). A dust atmosphere was generated, in which approximately 76% of the particles were respiratory. The highest attainable concentration of 2.25 mg/L did not result in any mortality in five male and five female rats after an exposure of 4 hours. There were also no overt signs of toxicity in relation to clinical signs, body weight, food consumption or gross pathology at necropsy after the 14 day observation period. The LC50 was concluded to be > 2.25 mg/L, the highest attainable concentration.
Justification for classification or non-classification
Based on the available information classification for acute oral or dermal toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008. Based on the fact that there were no treatment related effects in the two inhalation studies at concentrations clearly above the limit for classification for Category 3, nor in both oral studies, it is concluded that classification for acute inhalation toxicity is also not warranted, although this cannot be fully ascertained, because it is technically impossible to test the substance up to the highest classification limit.
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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