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Registration Dossier
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EC number: 232-979-7 | CAS number: 9074-98-0
Endpoint summary
Administrative data
Description of key information
Based on the available information, the test item is determined as a non-irritant for the eye or the skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- Not reported in this summary report
- Specific details on test material used for the study:
- - Name as used in the study report: glucanase preparation
- concentration: 63000 U/g - Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- 3 min, 1 hour, and 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Remarks on result:
- other: see below 'Irritant/corrosive response data'
- Irritant / corrosive response data:
- Erythaema was seen in two out of three rabbits after 24 and 48 hours which had disappeared after 72 hours.
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to the read-across justification attached to section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- overall irritation score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across Cellulase 2000L
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across endo-1,3-beta-glucanase
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across endo-1,3-beta-glucanase
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across endo-1,3-beta-glucanase
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on Read-across Natugrain TS_2006
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on Read-across Natugrain TS_2006
- Irritant / corrosive response data:
- No indications of irritation.
Referenceopen allclose all
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:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- Not reported in this summary report
- Specific details on test material used for the study:
- - Name as used in the study report: glucanase
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A single application to the conjunctival sac.
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- A single application to the conjunctival sac produced moderate conjunctival irritation for two to three days.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to the read-across justification attached to section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Result read-across Cellulase 2000L
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Result read-across Cellulase 2000L
- Irritation parameter:
- other:
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across GBR 50010 (endo-1,3-beta-glucanase)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across GBR 50010 (endo-1,3-beta-glucanase)
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across GBR 50010 (endo-1,3-beta-glucanase)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across GBR 50010 (endo-1,3-beta-glucanase)
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Result read-across GBR 50010 (endo-1,3-beta-glucanase)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on Read-across Natugrain TS_2006
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on Read-across Natugrain TS_2006
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Based on Read-across Natugrain TS_2006
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Based on Read-across Natugrain TS_2006
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
As only limitedly reported studies are available for the test substance itself, also read-across is made to two structural analogues of the test substance.
Skin irritation / corrosion
A skin irritation and corrosion study in accordance with OECD TG 404 on glucanase, the test substance itself, is briefly reported (Efsa, 2011). The test substance was applied to intact skin of three rabbits for an unspecified period and skin reactions were observed up to 72 hours. Some erythema was observed in two out of three rabbits after 24 and 48 hours, but no scores were presented. The effects had disappeared after 72 hours.
A skin irritation and corrosion study in accordance with OECD TG 404 was done on Cellulase 2000L, which is an enzyme complex of cellulase, ß-glucanase and hemicellulase, which are all close analogues (Dupont, 2015). The principal enzyme activity of cellulase is endo-1,4-ß-glucanase. The test substance was applied as a single dose of 0.5 mL on one 6 cm2 intact site of three rabbits for 4 hours. At the end of the exposure period, the skin was washed and dermal irritation evaluated up to 72 hours. No dermal reactions were noted.
Two skin irritation and corrosion studies in accordance with OECD TG 404 are available for endo-1,3-ß-glucanase. In a briefly reported study, 0.5 mL of the test substance was applied for 4 hours to clipped areas of three rabbits. No dermal irritation was observed at any dose site during the study with an observation period up to 72 hours (Dupont, 2015).
Moreover, an acute dermal irritation study in the rabbit, under occlusive conditions, according to OECD guideline 404, was conducted with Natugrain TS powder (BASFSE, 2006), a preparation containing the test item in a mixture with xylanase, and showed that this preparation was non-irritant.
Eye irritation
An eye irritation study in accordance with OECD TG 405 on glucanase, the test substance itself, is briefly reported (Efsa, 2011). A single application to the conjunctival sac of three rabbits produced moderate conjunctival irritation for two to three days.
An eye irritation study in accordance with OECD TG 405 was also done on Cellulase 2000L, which is an enzyme complex of cellulase, ß-glucanase and hemicellulase, which are all close analogues (Dupont, 2015). The principal enzyme activity of cellulase is endo-1,4-ß-glucanase. 0.1 mL of the test substance was instilled onto the conjunctival sac of one eye of each of three rabbits, while the untreated eye served as a control. Observations were made up to 72 hours and then up to 7 days. A very slight irritation was seen (mean overall score of 2.0 at a maximum of 110.0) after 1 hour, which was fully reversible within 24 hours. The mean overall irritation score of 24/48/72 hours was 0.0.
Two eye irritation studies according to OECD TG 405 are also reported for GBR50010 (endo-1,3-ß-glucanase). In a briefly reported study (Dupont, 2015), 0.1 mL was instilled into one eye of 3 rabbits, while the other eye was used as a control. One animal showed a conjuctivae score of 1.0 (maximum is 4.0) after 1 hour, which was fully reversible within 24 hours. There were no indications of irritation in any of the animals after 24/48/72 hours.
In addition, an acute eye irritation study with Natugrain TS powder, a preparation containig the test item as a mixture with xylanase, was performed in rabbits (BASFSE, 2006), in accordance to OECD guideline 405, and it was concluded that the preparation did not show an eye irritation potential.
Justification for classification or non-classification
Based on the available data classification and labelling for skin and eye irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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.
