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EC number: 232-668-6 | CAS number: 9003-99-0
- 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
Acute toxicity via the oral route has been tested. No signs of toxicity were observed in rats treated with a single oral dose of 2.1 mg enzyme concentrate dry matter/kg bw. The test was conducted according to OECD guidelines and GLP standards.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 11, 1996 - March 6, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline 401, 1987
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- Deviation had no influence on the outcome of the study.
- Principles of method if other than guideline:
- Deviation from the protocol: Most of the rats included in the present study had a body weight of up to 14 g more than prescribed in the protocol at the time of dosing. Guideline dictates to use young adults in order to use the individual weight and the weight gain as sensitive parameters. The animals used in the present study had, however, more than 4 weeks left of their growth period and this deviation had therefore no influence on the outcome of the study.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding Centre Ltd., Ejby, Denmark.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 4-6 weeks (max 8 weeks)
- Weight at study initiation: Females: 150-164 g and Males: 153-184 g
- Fasting period before study: The animals were fasted from the afternoon the day before the day of dosing until three hours after dosing.
- Housing: Rats were housed in a barrier maintained animal room
- Diet: Ad libitum (Altromin rat/mouse Breeding 1320 diet pellets)
- Water: Ad libitum (The study tap water added citric acid to pH 2-3)
- Acclimation period: 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: 1996-03-14 To: 1996-04-02 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10.3 % w/v
- Amount of vehicle (if gavage): 20 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
- Doses:
- 2.01 g enzyme concentrate dry matter/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females per dose.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Clinical signs observation: All animals were observed for any clinical symptoms before dosing and 2 and 3 hours after dosing and subsequently once a day for the following 14 days.
- Body weight observation: Animals were weighed on day 1 (before dosing), 8 and 15 (before necropsy)
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examination of the animals revealed no abnormalities related to the treatment with peroxidase. - Statistics:
- Body weights and weight gains were compared between groups using a GLM procedure (General Linear Models).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 100 mg/kg bw
- Based on:
- other: enzyme concentrated dry matter
- Mortality:
- No animals died during the observation period.
- Clinical signs:
- other: There were no clinical signs of reaction to the treatment in any of the groups.
- Gross pathology:
- Necropsy findings: Macroscopic examination of the animals revealed no abnormalities related to the treatment with peroxidase.
- Interpretation of results:
- other: Data insufficient for classification as 2100 mg enzyme concentrate dry matter/kg bw correspond to only 795.3 mg active enzyme protein/kg bw.
- Conclusions:
- Peroxidase, batch PPX 5156, can be considered as non-toxic, given as a single orally administered dose up to 2.1 g enzyme concentrate dry material/kg body weight.
- Executive summary:
This study was performed to evaluate the toxic potential of the present peroxidase. The study was conducted in compliance with OECD Guideline No. 401, 1987.
The test substance was administered once orally by gavage to 2 groups of 5 male and 5 female fasted Wistar rats at dose levels of 0 and 2.1 g peroxidase, enzyme concentrate dry matter/kg body weight. Dose volume was 20 ml/kg body weight.
Clinical signs were recorded daily, whilst body weight was recorded on day 1, 8 and 15. After completion of 14 days of observation, all animals were killed and necropsied.
No mortalities occurred and no signs of toxicity were seen during the observation period. At necropsy no treatment-related findings were seen.
Peroxidase, batch PPX 5156, can be considered as non-toxic, given as a single orally administered dose up to 2.1 g enzyme concentrated dry material/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Substantial documentation on the safety of the production strain has been generated, and the enzyme test material was thoroughly characterized. The study was conducted in accordance with OECD test guidline No. 401, 1987 and in compliance with GLP. The database can thus be considered of high quality.
Additional information
Justification for classification or non-classification
Data insufficient for classification as 2100 mg enzyme concentrate dry matter/kg bw correspond to only 795.3 mg active enzyme protein/kg bw.
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