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EC number: 232-615-7 | CAS number: 9001-57-4
- 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
Skin irritation (OECD 404, GLP), rabbit: not irritating
Read-across substance: Endoxylanase (CAS 9025-57-4)
Eye irritation (OECD 405, GLP), rabbit: not irritating
Read-across substance: Endoxylanase (CAS 9025-57-4)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The read-across approach is detailed in the analogue justification. The target and source substances are considered unlikely to differ in their skin irritation potential. Based on the results of the available skin irritation/corrosion study conducted with the source substance endoxylanase (CAS 9025-57-4) the test substance did not show irritant properties towards the skin. The target substance β-fructofuranosidase (CAS 9001-57-4) is not expected to be irritant towards the eyes. CLP: not classified
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 22 February 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- yes
- Remarks:
- occlusive dressing used: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal, this coverage
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin, Berlin, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxicology department Rallis Research Centre, Bangalore, India
- Age at study initiation: 5 - 6 months
- Weight at study initiation: 2.16 - 2.31 kg
- Housing: individually in fibre board cages (size: L 77 x B 54 x H 63 cm) with steam sterilized paddy husk bedding
- Diet: Rabbit feed (Nav Maharashtra Chakan Oil Mills Ltd., Maharashtra, India), ad libitum
- Water: Deep bore-well water, ad libitum
- Acclimation period: 7 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 Feb 2002 To: 18 Feb 2002 - Type of coverage:
- other: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
NEGATIVE CONTROL
- bare cotton gauze of similar size without any test item applied - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left side of the dorso-lateral thoracic surface, appriximately 6 cm² (2 x 3 cm)
- Type of wrap if used: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing: flushed with deionised water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize scroing system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No local reactions (erythema, edema) indicative for skin irritation have been observed 1 h after patch removal in any animal.
- Other effects:
- - Other adverse local effects:
There were no skin reactions.
- Other adverse systemic effects: There were no pre-termial deaths, no effects on body weight and no signs of toxicity observed. Also at necropsy no abnormaility was detected. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- A reliable study conducted in accordance with OECD 404 and GLP, determined the test material to be non-irritating to the skin of rabbits. No edema or erythema were observed at any time point. CLP: not classified
Referenceopen allclose all
The read-across approach is detailed in the analogue justification. The target and source substances are considered unlikely to differ in their skin irritation potential. Based on the results of the available dermal irritation/corrosion study conducted with the source substance endoxylanase (CAS 9025-57-4), the test substance was not irritating to skin. The target substance beta-fructofuranosidase (CAS 9001 -57 -4) is not expected to be hazardous to be irritant to skin..
Table 1: Test for Irritant Effects on the Skin (Expos.: 4 h) Draize grade
animal number |
1 h |
24 h |
48 h |
72 h |
||||
|
erythema |
edema |
erythema |
edema |
erythema |
edema |
erythema |
edema |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Vehicle:
- unchanged (no vehicle)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Additional time point 1h (for further details please refer to table 1 in the "Any other information on results incl. tables):
Cornea opacity: mean / of 3 animals was 0.
Iris score: mean / of 3 animals was 0.
Conjuctivae score: mean / of 3 animals 0.
Chemosis score: mean / of 3 animals 0. - Other effects:
- - Ophthalmoscopic findings:
No eye reactions, indicating irritation, were observed.
- Other observations: No deaths were observed and the body weights of all rabbits increased during the observation period. There were no signs of toxicity observed and necropsy did not reveal any abnormalities. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- The read-across approach is detailed in the analogue justification. The target and source substances are considered unlikely to differ in their eye irritation potential. Based on the results of the available eye irritation/corrosion study conducted with the source substance Endoxylanase (CAS 9025-57-4) the test substance did not show irritant properties towards the eyes. The target substance β-fructofuranosidase (CAS 9001-57-4) is not expected to be irritant towards the eyes. CLP: not classified
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 - 24 February 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin, Berlin, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Toxicology department Rallis Research Centre, Bangalore, India
- Age at study initiation: 5 - 6 months
- Weight at study initiation: 2.09 - 2.29 g
- Housing: individually in fibre board cages (size: L 77 x B 54 x H 63 cm) with steam sterilized paddy husk bedding
- Diet: Rabbit feed (Nav Maharashtra Chakan Oil Mills Ltd., Maharashtra, India), ad libitum
- Water: Deep bore-well water, ad libitum
- Acclimation period: 7 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 Feb 2002 To: 24 Feb 2002 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: eyes were irrigated with deionised water
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
INTERPRETATION OF RESULTS: Modified version of the Kay and Calandra System. The numeric values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae was designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:
Score for conjunctivae = (A+ B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C. 1962., (J. Soc. Cosmet. Chem., 13:281 -289) was used to classify the ocular irritancy potential of the test item. This is achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation was calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled the classification of the eye irritancy potential of the test item.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Additional time point 1h (for further details please refer to table 1 in the "Any other information on results incl. tables):
Cornea opacity: mean / of 3 animals was 0.
Iris score: mean / of 3 animals was 0.
Conjuctivae score: mean / of 3 animals 0.
Chemosis score: mean / of 3 animals 0. - Other effects:
- - Ophthalmoscopic findings:
No eye reactions, indicating irritation, were observed.
- Other observations: No deaths were observed and the body weights of all rabbits increased during the observation period. There were no signs of toxicity observed and necropsy did not reveal any abnormalities. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the acute eye irritation/corrosion test, the test substance did not show irritant properties towards the eyes. CLP: not classified
Referenceopen allclose all
Table 1: Results of eye irritation study.
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
swelling |
||||
1 |
1 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.0 |
0.0 |
0.0 |
0.0 |
|
2 |
1 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.0 |
0.0 |
0.0 |
0.0 |
|
3 |
1 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.0 |
0.0 |
0.0 |
0.0 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
0.00 |
0.00 |
0.00 |
0.00 |
24 |
0.00 |
0.00 |
0.00 |
0.00 |
|
48 |
0.00 |
0.00 |
0.00 |
0.00 |
|
72 |
0.00 |
0.00 |
0.00 |
0.00 |
|
24+48+72 |
0.00 |
0.00 |
0.00 |
0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for read-across:
There are no experimental data available regarding the skin and eye irritation/corrosion of β-fructofuranosidase (CAS 9001-57-4). It must be noted however that β-fructofuranosidase is produced by a classical strain of Saccharomyces cerevisiae, which has a long history of safe use in food applications globally. Read-across from an appropriate analogue substance endoxylanase (CAS 9025-57-4) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5 in order to fulfil the standard information requirements defined in Regulation (EC) No 1907/2006, Annex VII and VIII, 8.1.
Common functional groups and structural similarities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin irritation in vivo
In the reliable skin irritation study, performed according to OECD TG 404 and in compliance with GLP, three New Zealand White rabbits were exposed to 0.5 mL of enzyme preparation (CAS 9025-57-4) onto clipped skin (6 cm2) for 4 h (Ravi, 2002). Cotton gauze without any dressing was used as control. Patches were secured to the body of the animal by adhesive tape and a crepe elastic bandage.
Skin reactions were evaluated according to the Draize scoring system 1, 24, 48 and 72 h post-application. No erythema or edema formation and no further local or systemic effects were observed in any animal during the study period. In addition, no deaths were observed during the study period, there were no effects on body weight and at necropsy, there were no abnormalities detected. Based on the study results, the test substance is not considered to be irritating to the skin.
A further reliable skin irritation study performed according to OECD TG 404 and in compliance with GLP, three New Zealand White rabbits were exposed to 0.5 g of enzyme preparation containing endoxylanase activity (CAS 9025 -57 -4) onto clipped skin (6 cm2) for 4 h under semi-occlusive conditions (Rees, 1995). Before test substance administration, the skin was moistened with 0.2 mL water. Semi-occlusive dressing without any substance served as control. Skin reactions were evaluated according to the Draize scoring system 1, 24, 48 and 72 h post-application. No erythema or edema formation and no further local or systemic effects were observed in any animal during the study period. Based on the study results, the test substance is not considered to be irritating to the skin.
Eye irritation in vivo
In the reliable eye irritation study with enzyme preparation containing endoxylanase activity (CAS 9025-57-4) was performed according to OECD TG 405 and in compliance with GLP (Ravi, 2002). In this study, 0.1 mL of the test substance was instilled in the eyes of three albino rabbits. The untreated eye served as control. After an exposure period of 24 hours, the treated eye was rinsed with deionised water. The eyes were observed and reactions were evaluated according to the Draize scoring system, 1, 24, 48, and 72 h after application. No effects on corneal opacity, conjunctival redness, chemosis and iris were noted at any time point in any animal. No deaths, no local or systemic effects and no necropsy findings were observed in any animal. Based on the obtained results, the test substance is not considered eye irritating.
A further reliable eye irritation study with enzyme preparation containing endoxylanase activity (CAS 9025 -57 -4) was performed according to OECD TG 405 and in compliance with GLP (Rees, 1995). In this study, 0.1 g of the test substance was instilled in the eyes of three albino rabbits. The untreated eye served as control. The eyes were observed and reactions were evaluated according to the Draize scoring, 1, 24, 48, 72 h and 8 and 15 days after application. No effects on corneal opacity and chemosis were noted at any time point in any animal. Iritis grade 1 was observed in one animal at the 1 h reading time point, but not at any later time point. Very slight conjunctivitis (redness) was evident in the treated eye of each animal 1 h after instillation. The conjunctival redness resolved by the 48 h observation in one animal and by Day 8 in the remaining rabbits. Based on the obtained results, the test substance is not considered to cause eye irritation requiring classification according to Regulation(EC) No. 1272/2008.
Conclusion on skin and eye irritation properties
The read-across approach is detailed in the analogue justification. The target and source substances are considered unlikely to differ in their skin or eye irritation potential. Based on the results of the available skin and eye irritation/corrosion studies conducted with the source substance endoxylanase (CAS 9025-57-4), the test substance did not show irritant properties towards the skin or eyes. Therefore the target substance β-fructofuranosidase (CAS 9001-57-4) is also not expected to be a skin or eye irritant. CLP: not classified
Justification for classification or non-classification
Based on the available data, the registration substance is considered not to meet the classification criteria according to Regulation (EC) No. 1272/2008 (CLP).
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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