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EC number: 642-981-3 | CAS number: 148465-73-0
- 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
Renilase SP 252 was tested in rabbits for skin and eye irritation.
- The skin irritation study was conducted according to the Code of Federal Regulations 1979, title 16 § 1500.41. Two of the six female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal, which gave a primary irritation score of 0.16. However, the reaction was fully reversible, and no irritation signs were seen at the reading at 24 hours. The irritation score for the mean of 24, 48 and 72 hours was 0. Therefore, according to the current classification, rennilase SP 252 is classified as a 'non irritant' to the skin.
- In the eye irritation study, no corneal opacity or iris reactions were noted in any of the animals at any time during the test. Mild redness and slight chemosis were seen in all of the rabbits estimated at 1 hour. At 24 hours mild redness was seen in 1 rabbit. At 48 and 72 hours no conjunctival reactions were seen in any of the rabbits. In conclusion, rennilase SP 252 can be classified as a 'non-irritant' to the rabbit 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:
- 1982-05-11 to 1982-06-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP and according to the Code of Federal Regulations 1979, title 16, 1500.41 and adapted to OECD Guidelines for Testing Chemicals
- Qualifier:
- according to guideline
- Guideline:
- other: Study conducted according to GLP and according to the Code of Federal Regulations 1979, title 16, 1500.41 and adapted to OECD Guidelines for Testing Chemicals.
- Version / remarks:
- 1979
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP equivalent at the time. The study was subject to appropriate inspection by the quality assurance unit.
- Species:
- rabbit
- Strain:
- other: Danish Landstrain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: 2.9-3.3 kg
- Housing: Individually in galvanized steel cages with mesh floors and automatic watering
- Diet (e.g. ad libitum): Standard diet
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22°C
- Humidity (%): 40 - 50%
IN-LIFE DATES: From: 1982-05-11 To: 1982-05-14 - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Remarks:
- Hair was clipped and skin abraded.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes, 24 hours, 48 hours and 72 hours.
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch by 1 inch
- Type of wrap if used: A coat of PVC
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30-60 minutes, 24 hours, 48 hours and 72 hours
SCORING SYSTEM:
Erythema and eschar formation
No erythema ....................................................................................................................................0
Very slight erythema (bar ely perceptible) ......................................................................................1
Well-defined erythema .....................................................................................................................2
Moderate to severe erythema ..........................................................................................................3
Severe erythema (beet redness) to slight eschar formations (injuries in the depth) ......................4
Edema formation
No edema ..........................................................................................................................................0
Very slight edema (bar ely perceptible) ............................................................................................1
Slight edema (edges of area well-defined by definite raising) .........................................................2
Moderate edema (raised approximately 1 millimeter) ........................................................................3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) ......... 4 - Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Two of the female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal. The reaction was reversible, and no signs were seen at the reading at 24 hours.
None of the other animals showed any signs of reaction to the test substance during the observation period. - Interpretation of results:
- not irritating
- Conclusions:
- The study was conducted according to the Code of Federal Regulations 1979, title 16 § 1500.41. Two of the six female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal, which gave a primary irritation score of 0.16. However, the reaction was fully reversible, and no signs were observed at the reading at 24 hours. The irritation score for the mean of 24, 48 and 72 hours was 0. Therefore, according to the current classification, rennilase SP 252 was classified as a "non irritant" to the skin.
- Executive summary:
The skin irritation effect of rennilase SP 252, batch PPR1289 was investigated according to the Code of Federal Regulations 1979, title 16 § 1500.41 and adapted to the OECD guidelines for testing of chemicals.
The study was performed on six rabbits. They were each exposed to 0.5 mL of the test material, applied under occlusive conditions to clipped intact and abraded skin (1 x 1 inch) on the back.
After a 4-hour exposure period, the test item was removed from the test site and the skin was examined after 30-60 minutes, 24 h, 48 h and 72 h.
Two of the six female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal, which gave a primary irritation score of 0.16. However, the reaction was fully reversible, and no irritation signs were seen at the reading at 24 hours. The irritation score for the mean of 24, 48 and 72 hours was 0.
Therefore, according to the current classification, rennilase SP 252 was classified as a "non irritant" to the skin.
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:
- key study
- Study period:
- 1982-04-20 to 1982-06-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method was proposed by OECD Guidelines for Testing Chemicals and evaluation made according to the Code of Federal Regulations, title 16, §1500.42.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing Chemicals and evaluation made according to the Code of Federal Regulations, title 16, §1500.42.
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP equivalent at the time where the conduct of the study was subject to appropriate inspection by the quality assurance unit.
- Species:
- rabbit
- Strain:
- other: Danish Landstrain
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: 2.9-3.2 kg
- Housing: Individually in galvanized steel cages with mesh floors and automatic watering
- Diet (e.g. ad libitum): Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 30 - 35%
IN-LIFE DATES: From: 1982-04-20 To: 1982-04-23 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Test batch used as is:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL into the left eye - Duration of treatment / exposure:
- 0.1 mL of the test substance was installed into the left eye of each rabbit by gently pulling the lower lid away from the eye ball, and the test substance was carefully introduced into the resulting cup. The lids were then gently held together for one second.
The right eye, remaining untreated, served as a control. - Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 6 rabbits (3 female + 3 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the Code of Federal Regulations, title 16 §1500.42 - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: #1, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Ulceration
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal opacity or iris reactions were noted at any time during the test. Mild redness and slight chemosis were seen in all of the rabbits estimated at 1 hour.
At 24 hours mild redness was seen in 1 rabbit.
Both observed reactions were fully reversible and at 48 and 72 hours no conjunctival reactions were seen in any of the rabbits. - Interpretation of results:
- not irritating
- Remarks:
- Not classified, Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, Rennilase SP 252 was regarded as negative to potential for eye injury.
- Executive summary:
In accordance with the proposed test method by OECD Guidelines for Testing Chemicals and with the evaluation conducted according to the Code of Fereral Regulation, title 1500.42, a test for eye irritation in rabbits was performed with rennilase SP 252, batch PPR 1289.
0.1 mL of rennilase SP 252, batch PPR 1289 was placed in the conjunctival sac of the left eye of six rabbits 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 or iris reactions were noted at any time during the test. Mild redness and slight chemosis were seen in all of the rabbits estimated at 1 hour. At 24 hours mild redness was seen in 1 rabbit. At 48 and 72 hours no conjunctival reactions were seen in any of the rabbits.
In conclusion, rennilase SP 252 was classified as a 'non-irritant' to the rabbit eye.
- 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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Not classified.
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