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EC number: 253-446-5 | CAS number: 37288-54-3
- 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
Mannanase is neither a skin nor an eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: 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
- Study period:
- November 5, 2002 – November 8, 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)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals were procured from Millbrook Breeding Labs, Amherst MA 10/23/02. Three healthy animals were selected after an equilibration period of at least five days. The test animals were born the week of August 4th, 2002 and pre-test body weights ranged from 2.3 to 2.5 kg.
Animals were identified by cage notation and metal ear tags. Animals were each housed in a separate suspended wire cage. Bedding was placed beneath each cage and changed at least three times per week. Fresh food (PMI Rabbit Chow Diet #5321) was provided daily. Water was freely available at all times. The animal room was used only for actue testing on rabbits. The room was temperature and humidity controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test article was used as received.
- Controls:
- no
- Amount / concentration applied:
- The test article was dosed by volume at 0.5 mL per rabbit.
- Duration of treatment / exposure:
- The test area was covered with a 4 ply surgical gauze patch and the torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape. The test article was kept in contact with the skin for 4 hours, at which time the wrappings were removed.
- Observation period:
- Observation of any dermal reactions were recorded at 1, 24, 48 and 72 hours after patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.
- Number of animals:
- Three (two males and one female)
- Details on study design:
- The dorsal area of the trunk of each animal was clipped free of hair on the day prior to the application of the test article. The site of administration was approximately 2.5 cm x 2.5 cm. The test article was dosed by volume at 0.5 mL per rabbit. The test area was covered with a 4 ply surgical gauze patch and the torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape. The test article was kept in contact with the skin for 4 hours, at which time the wrappings were removed. Observation of any dermal reactions were recorded at 1, 24, 48 and 72 hours after patch removal. Residual test article was removed from the test site by gentle washing with distilled water prior to scoring observations.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No erythema observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No erythema observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No erythema observed.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No edema observed.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No edema observed.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No edema observed.
- Irritant / corrosive response data:
- There were no erythema or edema noted. There were no overt signs of systemic toxicity. The Primary Irritation Score was determined to be 0.
- Other effects:
- None.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article is not irritating to skin. Mannanase shall be classified as 'Non Irritant'.
- Executive summary:
Three New Zealand White rabbits (2 males : 1 female) were used. The test article (0.5 mL) was applied to one intact dermal site/rabbit. The test article was kept in contact with the skin for 4 hours, at which time the wrappings were removed. Dermal reactions were scored at 1, 24, 48 and 72 hours after patch removal. There were no erythema or edema noted at any time during the study period. There were no overt signs of systemic toxicity. The Primary Irritation Score was determined to be 0 and mannanase shall be classified as 'Non Irritant'.
Referenceopen allclose all
Systemic observations were also made at 1, 24, 48, and 72 hours after patch removal. All observations were normal at all time points in all test animals. There were no abnormal clinical signs observed and all body weight changes were normal.
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:
- key study
- Study period:
- 04 November 2002 - 07 November 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)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The animals were supplied by Millbrook Breeding Labs, Amherst, MA.
The animals were born 08/04/2002. The pre-test body weight range was 2.4-2.6 kg. They were housed 1 per cage in suspended cages. The animal room was temperature controlled and had a 12-hour light/dark cycle. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye was dosed, while the other served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- After instillation, the eyelids were held together for approximately one second.
- Observation period (in vivo):
- The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours.
- Number of animals or in vitro replicates:
- 2 male and 1 female rabbit
- Details on study design:
- Scoring was done according to the Draize technique and OECD TG 405.
The eyes were not washed. Sodium fluorescein dye procedure was used at the 24-hour observation period.
A mini-Maglite flashlight with high intensity bulb was used for the examination. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no corneal opacity or iritis noted at any observation period. As to conjunctival irritation, the following was noted: At the 1 hour reading, slight conjunctival effects in the form of redness, chemosis and discharge were present (score 1 for all parameters) in rabbit # 1, 2 and 3. In two animals this effect had disappeared at the following observations (24, 48 and 72 hours after treatment). At the examination at 24 hours after exposure, slight redness (score 1) without any swelling of the conjunctiva or any discharge remained in one of the three rabbits. All eye effects had cleared completely at the following observations, 48 and 72 hours after treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mannanase is not classified as an eye irritant.
- Executive summary:
Three New Zealand White rabbits (2 males : 1 female) were used. 0.1 mL of mannanase was placed into the conjunctival sac of one eye of each rabbit. The eyes were examined and scored at 1, 24, 48 and 72 hours after dosing using Draize techniques. Sodium fluorescein dye procedure was used at the 24-hour observation period. The untreated eye served as control. No corneal opacity was noted at any scoring period. Slight conjuctival irritation was observed, but this cleared within 48 hours. The Primary Irritation Score was determined to be less than 1 and mannanase shall be classified as 'Non Irritant'.
GHS Classification: Not Classified
- 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
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The skin and eye irritation potential of mannanase has been tested according to OECD guidelines, in compliance with GLP. No effects were seen at all in the skin irritation study. Only transient conjunctival reactions were seen in the eye irritation study. All findings were fully reversible within 48 hrs.
The conclusion was that mannanase is neither a skin nor an eye irritant.
Justification for classification or non-classification
The skin and eye irritation potential of mannanase has been tested according to OECD guidelines and in compliance with GLP. The conclusion was that mannanase did not exert any skin and eye irritation and therefore should not be classified.
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