Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 629-845-9 | CAS number: 9001-89-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Active enzyme of 4-phytase (CAS 9001-89-2, IUBMB 3.1.3.26)
- Molecular formula:
- Not applicable, see remarks.
- IUPAC Name:
- Active enzyme of 4-phytase (CAS 9001-89-2, IUBMB 3.1.3.26)
- 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:
- 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:
- 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:
- 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:
- liquid
- Details on test material:
- % Total Organic Solids: 25.27%
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: Charles River, D-88353 Kisslegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.5-3.7 kg
- Housing: Individually kept in PPO-plast cages (floor area: 4200 cm2) with perforated floor. The tray under the floor was cleaned twice per week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 2 months
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 3°C
- Humidity (%): 55% ±°15%
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hour dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The fourth quadrant of the preliminary test was used as a negative control
- Amount / concentration applied:
- 0.5 mL (which is equivalent to 132.51 mg enzyme concentrate dry matter/mL or 78.19 mg active enzyme protein/mL)
- Duration of treatment / exposure:
- Preliminary Test: 3 minutes, 1 hour, 4 hours
Confirmatory Test: 4 hours - Observation period:
- 72 hours; one animal was further observed on Day 8
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze patch to cover the test area. Each gauze patch was fixed to the site with Scanpor tape. Nobafix gauze was loosely wound the trunk to secure the dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water and mild soap
- Time after start of exposure: Initial Test: 3 minutes
OBSERVATION TIME POINTS: Immediately after patch removal, 1 hour, 24, 48, and 72 hours
SCORING SYSTEM: See another information on materials and methods for scoring scale.
- Method of calculation: The animals were graded on a numerical scale for the 4 hour exposure time based on 3 readings (24, 48, and 72 hours) for both erythema and edema. The scores were then divided by 3 to obtain to obtain Individual Mean Scores for each rabbit. The mean score erythema and edema for the three rabbits was calculated from the Individual Mean Scores.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: mean score of all animals
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days for initial animal and 48 hours for other 2 animals
- Irritation parameter:
- edema score
- Basis:
- other: mean score of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Initial Test
No clinical signs were observed in the animal during daily observations. No oedema was observed at the test or control sites at any of the examinations at termination of exposure, and neither at the examinations at 1, 24, 48, or 72 hours after exposure termination. Very slight erythema was observed at the 4-hour exposure test site at 1, 24, 48, and 72 hours after exposure. No reactions were observed 8 days after treatment. For the 4- hour test site, the Individual Mean Score calculated using only the scores from the 24, 48, and 72 hour observations points were 1.0 and 0.0 for erythema and oedema, respectively.
Confirmatory Test
No clinical signs were observed in the animals during daily observations. No oedema was observed at the test or control sites at any of the examinations at termination of exposure, and neither at the examinations at 1, 24, 48, or 72 hours after exposure termination. Very slight erythema was observed in both animals. One animal had very slight erythema at the readings 24 and 48 hours after exposure and the other had very slight erythema 1, 24, and 48 hours after exposure. The Individual Mean Scores for erythema and oedema for both of the remaining animals were 0.7 and 0.0, respectively.
The Individual Mean Scores were combined to give an overall Mean Score for the test item, which were 0.8 and 0.0 for erythema and oedema, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The overall test substance Mean Scores (all three animals) was 0.8 and 0.0 for erythema and oedema, respectively.
- Executive summary:
The objective of the study was to evaluate local irritant effects of the test substance to rabbit skin following a single topical exposure. The study was conducted according to OECD Guideline 404 and evaluated by the Commission Directive 2001/59/EC of 6 August 2001 adapting to technical for the 28th time Council Directive 67/548/ECC.
The initial test was carried out on one rabbit with the back divided into 4 quadrants. The sites were used to examine the test substance at 3 minutes, 1 hour, and 4-hour exposure times and the last quadrant was a negative control. The animal was observed and scored at 1, 24, 48, and 72 hours after exposure. Very slight erythema (barely perceptible) was observed at the 4-hour test site at the readings 1 hour, 24, 48, and 72 hours after termination of exposure. No oedema was observed.
A confirmatory test was carried out concurrently with two additional rabbits with only a 4-hour exposure site (0.5 mL per test site which is equivalent to 132.51 mg enzyme concentrate dry matter/mL or 78.19 mg active enzyme protein/mL) and a negative control. The animals were observed and scored 1, 24, 48, and 72 hours. Very slight erythema (barely perceptible) was observed in one animal at 24 and 48 hours after termination of exposure and at 1, 24, and 48 hours in the second animal. No oedema was observed. No clinical signs were observed in any of the animals during the daily observations.
The overall test substance Mean Scores (all three animals) was 0.8 and 0.0 for erythema and oedema, respectively.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.