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EC number: 232-766-9 | CAS number: 9015-75-2
- 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
Pectate lyase was tested for skin and eye irritation in rabbits.
- There were no erythema or edema noted at any of the readings of the dermal reactions in treating rabbit skin (2.5 x 2.5 cm) with pectate lyase for 4 hours. Therefore, pectate lyase should not be classified as an irritant.
- No corneal opacity, iris reactions or tear secretion were noted at any time during the test. Slight conjunctival reaction and chemosis were observed earlier on. However, all signs were reversible, and no reactions were seen after 48 or 72 hours. The rabbits showed no signs of systemic reaction to the treatment.
In conclusion, pectate lyase can be classified as a ‘non irritant’ to the eye.
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
- Study period:
- From 1999-02-15 to 1999-05-05
- 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:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC
- Version / remarks:
- EEC (1992) Acute Toxicity (Skin irritation). Section B4 (L383A/124-L383A/127) of the Annex to
the European Communities Directive 92/69/EEC. The Official Journal of the European communities
L383A (vol. 35), 29 December 1992 (ISSN 0378-6978). - Deviations:
- no
- Principles of method if other than guideline:
- During acclimatisation and experimental period the weight of two of the animals was up to 1/2 kg less than aimed in protocol. This was due to reduced water intake of especially rabbit No. 6 during the acclimatisation period. When the rabbits were offered water in a bowl the weight of rabbit No. 6 increased by 1/2 kg within three days. As the skin of all rabbits tested were without signs of dehydration this deviation from protocol are not considered to have had any influence on the conclusion of the study.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Danish Landrace, albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Statens Seruminstitut "Hvidesten", Denmark
- Weight at study initiation: between 2.08 - 2.56 kg
- Age at study initiation: Young adults
- Housing: Individually, in animal room with control of temperature (20±3°C) and humidity (30-70%)
- Diet: 110 g standard diet per day (Altromin 2110, Standard Diet for Rabbits) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 8 days for animal no. 1 and 3 and 14 days for animal no. 6
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
IN-LIFE DATES:
From: 1999-02-22 To: 1999-03-05 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0.5-1, 24, 48, 72 hrs
- Number of animals:
- 3
- Details on study design:
- The test compound Pectate Lyase was assessed by semiocclusive application of 0.5 mL of the test material formulation to an area of 2.5 x 2.5 cm on the closel clipped flank of three male albino rabbits for 4 hrs.
The study was conducted to comply with the following guidelines:
- Organisation for Economic Co-operation and Development (OECD) test guideline 404.
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch and plaster
REMOVAL OF TEST SUBSTANCE
- Washing: Washed with water
OBSERVATION TIME POINTS
0.5-1, 24, 48, 72 hrs
SCORING SYSTEM:
- Method of calculation:
Erythema and eschar formation Grade
No erythema ...................................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................................1
Defined erythema ............................................................................................................................2
Moderate to severe erythema .........................................................................................................3
Severe erythema (beet redness) to slight eschar formations (injuries in depth) ...........................4
Oedema formation
No oedema .......................................................................................................................................0
Very slight oedema (barely perceptible) ..........................................................................................1
Slight oedema (edges of area well defined by definite raising) .......................................................2
Moderate oedema (raised approximately 1 mm) ...............................................................................3 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No erythema, eschar formation or oedema was observed at the test sites at any of the six rabbits at the examinations 1, 24, 48 or 72 hours after termination of exposure.
Two rabbits showed skin reaction related to the outer rim of the application area where the skin was exposed to both plaster and test material. This is not considered as an effect related to irritative properties of the test material. - Other effects:
- No other effects.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no erythema or edema noted at any of the readings of the dermal reactions in treating rabbit skin (2.5 x 2.5 cm) with pectate lyase for 4 hours. Therefore, pectate lyase should not be classified as an irritant.
- Executive summary:
The acute dermal irritant effect of pectate lyase was investigated according to the method recommended in the OECD Guideline No 404, “Acute Dermal Irritation/Corrosion”. The study was conducted in accordance with GLP. The study was performed on three male albino rabbits, Danish Landrace. They were each exposed to 0.5 mL of the undiluted liquid test item applied under semiocclusive conditions to each of three closely-clipped test sites, 2.5 x 2.5 cm. After a 4-hour exposure period, the test item was removed from the test site and the skin was examined.
Dermal reactions were scored at 0.5-1, 24, 48 and 72 hours after patch removal. There were no erythema or edema noted at any of the readings of the dermal reactions.
Under the conditions of this test and criteria of the EEC Directive, pectate lyase should not be classified.
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
- Study period:
- From 1999-02-15 to 1999-05-05
- 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:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC
- Version / remarks:
- EEC (1992). Acute Toxicity (Eye irritation). Section B5 (L383A/127-L383A/130) of the Annex to
the European Communities Commision Directive 92/69/EEC. The Official Journal of the European
Communities L.383A ( Vol. 35), 29 December 1992 (ISBN 0378-6978). - Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Danish Landrace, albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Statens Seruminstitut "Hvidesten", Denmark
- Weight at study initiation: between 2.14 - 2.56 kg
- Age at study initiation: Young adults
- Housing: Individually, in animal room with control of temperature (20±3°C) and humidity (30-70%)
- Diet: 110 g standard diet per day (Altromin 2110, Standard diet for rabbits) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 14 days
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
IN-LIFE DATES:
From: 1999-02-22 To: 1999-03-12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Test batch used as is.
- Amount(s) applied (volume or weight with unit): 0.1 mL into the left eye - Duration of treatment / exposure:
- The test material was applied to the conjunctival sac. The lids were gently held together for approximately 1 second. The untreated eye served as a control.
- Observation period (in vivo):
- The reactions were judged 1, 24, 48 and 72 hours after instillation of the test material.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not specified
SCORING SYSTEM: The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the guideline. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #2, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: Tear secretion
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal opacity, iris reactions or tear secretion were noted at any time during the test. Conjunctiva! reaction (redness, score 1) was observed in two rabbits at the 1 hour reading and in one rabbit at the 24 hour reading. Chemosis (score 1) was observed at the 1 hour reading in two animals. All signs were reversible, and no reactions were seen after 48 or 72 hours. The rabbits showed no signs of systemic reaction to the treatment.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No corneal opacity, iris reactions or tear secretion were noted at any time during the test. Slight conjunctival reaction and chemosis were observed earlier on. However, all signs were reversible, and no reactions were seen after 48 or 72 hours. The rabbits showed no signs of systemic reaction to the treatment.
In conclusion, pectate lyase can be classified as a ‘non irritant’ to the eye. - Executive summary:
In accordance with the OECD guideline 405, a test for eye irritation in rabbits was performed with pectate lyase, batch PPE 6345.
The eyes of three animals were checked for irritation before instillation and only healthy animals were used. 0.5 mL of pectate lyase, batch PPE 6345 was placed in the conjunctival sac of the left eye by pulling the lower eyelid away from the eyeball. The lids were gently held together for about one second after instillation. The untreated eye served as control. The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the specified guideline.
No corneal opacity, iris reactions or tear secretion were noted at any time during the test. Conjunctival reaction (redness, score 1) was observed in two rabbits at the 1 hour reading and in one rabbit at the 24 hour reading. Chemosis (score 1) was observed at the 1 hour reading in two animals. All signs were reversible, and no reactions were seen after 48 or 72 hours. The rabbits showed no signs of systemic reaction to the treatment.
In conclusion, pectate lyase can be classified as a 'non-irritant' to the rabbit eye.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results of skin and eye irritation tests, pectate lyase cannot be classified.
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