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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
Endpoint summary
Administrative data
Description of key information
The skin and eye irritation potential of 4 -phytase has been tested and no dermal or eye irritation was observed.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- 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
- 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. - 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. - 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.
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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, D-88353, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.1 - 5.1 kg
- Housing: Kept individually in PPO- plastic 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: 4 months for first animal and 2 weeks for additional animals
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 3C°
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of undiluted test item was used (equivalent to 26.51 mg enzyme concentrate dry matter/mL or 15.64 mg active enzyme protein/mL) - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: Test substance was not removed after application to the eye.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: At 24 hours after treatment, instillation of Fluorescein followed by flushing with 0.9% NaCl was included. Both eyes were examined again using UV light to detect corneal damage. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: ALL
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: ALL
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: ALL
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: ALL
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed in any of the animals.
- Other effects:
- No clinical signs were observed in daily observations
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritation was observed in any animal tested.
- Executive summary:
The objective of this study was to assess the ocular irritation potential of the test substance following OECD Guideline 405. The initial test, with 0.1 mL of test substance (equivalent to 26.51 mg enzyme concentrate dry matter/mL or 15.64 mg active enzyme protein/mL). applied to the left eye and the right eye as control, was conducted on one rabbit. After 24 hours, fluorescein was instilled and rinsed with 0.9% NaCl. The eye was examined with a UV light to detect corneal damage. The eye was also examined at 48 and 72 hours. Changes in the eye were graded according to a numerical scale 1, 24, 48, and72 hours after treatment. The confirmatory tests were carried out on an additional 2 rabbits and the tests and examinations were performed in a similar manner.
No clinical signs were observed in the animals during the daily observations. The mean values for all three rabbits were 0 for cornea opacity, iris lesion, chemosis of conjunctiva, and redness of conjunctiva.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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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