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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-04-19 to 2000-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Peroxidase
- EC Number:
- 232-668-6
- EC Name:
- Peroxidase
- Cas Number:
- 9003-99-0
- Molecular formula:
- Not applicable, see remarks.
- IUPAC Name:
- Peroxidase IUBMB 1.11.1.7
- 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.
- 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.
- 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.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Lot/batch No.: PPX 5156
- Expiration date of the lot/batch: At least 2005.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novozymes A/S (formerly Novo Nordisk A/S), Denmark.
- Age at study initiation: 17-19 weeks.
- Weight at study initiation: Between 2.6 - 2.7 kg.
- Housing: Individually in plastic cages with mesh floor and automatic watering.
- Diet: 130 g standard diet daily (Altromin 2110).
- Water: Ad libitum tap water.
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Remarks:
- 0.5 g of test substance moistened with 0.9 w/v % NaCl.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (equivalent to 0.49 g enzyme concentrated dry matter)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance moistened with 0.9 w/v % NaCl.
Adjacent areas of untreated skin served as control. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0.5-1, 24, 48 and 72 h after patch removal using the scoring system.
If skin reactions were observed, further assessments were conducted up to 21 days after test material application to determine the reversibility of the reactions. - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: The test compound peroxidase was assessed by semiocclusive application of 0.5 g of the test material, moisted with saline, to an area of 2.5 x 2.5 cm on the shaved skin on the back of three rabbits for 4 hrs.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 4 hours of exposure the patches were removed gently and the remaining test substance washed off with water.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 0.5-1, 24, 48 and 72 h after patch removal using the scoring system. In addition, the animals were observed daily for systemic signs of toxicity.
SCORING SYSTEM:
Erythema and eschar fonnation Grade
No erythema .................................................................................................................................0
Very slight erythema (barely perceptible) ....................................................................................1
Well defined erythema ..................................................................................................................2
Moderate to severe erythema ......................................................................................................3
Severe erythema (beet redness) to slight eschar formations (injuries in depth) ........................4
Oedema formation
No oedema ....................................................................................................................................0
Very slight oedema (barely perceptible) ..................................................................................... 1
Slight oedema (edges of area well defined by definite raising) ...................................................2
Moderate oedema (raised approximately 1 mm) ...........................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) .................. 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Dermal reaction was observed at the test site of all animals at the readings 1, 24 and 48 hours after test substance removal. The scores never exceeded 2. At 72 hours after test substance removal and the following two days two animals showed redness at the site of application. From day 6 until day 8 skin reaction (redness) was seen in only one animal. The reaction never exceeded a score of one. Nine days after removal of the test substance no reaction was observed.
- Other effects:
- No other effects.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Under the conditions of this test and criteria of the EEC Guideline, peroxidase batch PPX 5156, was classified as 'non-irritant to skin' as the reaction never exceeded a score higher than 1 and as the skin reaction had disappeared within the first 9 days of the 21-day observation period.
- Executive summary:
The acute dermal irritant effect of peroxidase was investigated according to OECD TG 404 (1992) “Acute Dermal Irritation/Corrosion”. The study was conducted in accordance with GLP.
The study was performed on three New Zealand White rabbits. 0.5 g test substance (equivalent to 0.49 g enzyme concentrate dry matter) was applied once under a semi-occlusive bandage to the shaved back skin of each of 3 rabbits. The length of exposure was 4 hours. The primary skin irritation was evaluated 0.5-1, 24, 48 and 72 hours after removal of the test substance. Irritation was observed in two animals at the reading 72 hours after test substance removal. No irritation was observed nine days after test substance removal. No systemic effects were observed.
Under the conditions of this test and criteria of the EEC Guideline, peroxidase batch PPX 5156, was classified as 'non-irritant to skin' as the reaction never exceeded a score higher than 1 and as the skin reaction had disappeared within the 21 day observation period.
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