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EC number: 402-130-7 | CAS number: 106246-33-7
- 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 in vivo:
The study was performed 1988 as GLP-test following OECD-method 404. The used species were New Zealand White rabbits; 3 females were treated with 500 mg test item, moistened with water. No effects were observed throughout the study period, all irritation scores were 0. In conclusion, the test item is not irritant to rabbit skin.
Skin irritation in-vitro:
The test item was found to be non-irritating in an in vivo skin irritation study on rabbits performed for new substance notification (ELINCS). Therefore, an in vitro skin irritation study does not need to be conducted.
Eye irritation in vivo:
The study was performed 1986 as GLP-test following EC-test method B.5. The used species were New Zealand White rabbits; 100 mg test item was instilled in the conjunctival sac of two males and one female. Conjunctival irritation was limited to slight redness and chemosis (score 1) in 1/3 rabbits and moderate redness, chemosis and discharge (score 2) in 2/3 rabbits at 1 h post instillation. After 24 h, slight redness persisted in 2/3 rabbits. By 48 h all treated eyes were normal. In conclusion, P5367 is not irritant to rabbit eyes.
Eye irritation in vitro:
The test item was found to be non-irritating in an in vivo eye irritation study on rabbits performed for new substance notification (ELINCS). Therefore, an in vitro eye irritation study does not need to be conducted.
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:
- key study
- Study period:
- April 1985
- 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
- GLP compliance:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: Ranch Rabbits, Crowley
- Age: at least 12 weeks
- Weight at study initiation: 2.10 - 4.05 kg
- Housing: individually in grid floor cages
- Diet: Standard Rabbit Diet, Special Diets Services Ltd., Stepfield
- Water: Mains water was provided at all times and dispensed from glass water bottles
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16 - 22°C
- Humidity: 40 - 70%
- Air changes: 10 changes /hour; single air-conditioned room
- Photoperiod: 14 hours darkness; 10 hours fluorescent lightning - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- observations were done 1, 24, 48 and 72 hours after treatment
- Number of animals:
- 3
- Details on study design:
- TREATMENT:
The back of each animal was clipped free of hair the day prior to treatment using electric veterinary clippers. A portion of test article (500 mg, moistened with water) was applied to an area of skin approximately 6 cm2 on each animal and covered with a gauze patch. The patch was occluded and secured using a strip of impermeable adhesive tape. A plastic collar was placed around the neck of each animal to prevent premature removal of the wrappings and ingestion of the test article. Four hours after application the patches were removed and the skin wiped with a disposable paper towel moistened with water to remove any test article still remaining.
EVALUATION OF EFFECTS:
One hour after removal of the wrappings the skin reactions were scored using the scale below.* The evaluation was repeated 24, 48 and 72 hours after removal of the patches. No irritation was noted at the 72 hour observation and the study was terminated. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No adverse skin reactions were noted up to 72 hours post-administration, when the study was terminated.
- Other effects:
- No adverse skin reactions were noted up to 72 hours post-administration, when the study was terminated.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be non-irritating to rabbit skin.
- Executive summary:
The study was performed 1988 as GLP-test following OECD-method 404. The used species were New Zealand White rabbits; 3 females were treated with 500 mg test item, moistened with water. No effects were observed throughout the study period, all irritation scores were 0. In conclusion, the test item is not irritant to rabbit skin.
- 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
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The test item was found to be non-irritating in an in-vivo skin irritation study on rabbits performed for new substance notification (ELINCS). Therefore, an in-vitro skin irritation study does not need to be conducted.
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:
- September 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: Two males and one female
- Source: Cheshire Rabbit Farms Ltd.
- Weight at study initiation: 2.5 - 3 kg
- Housing: individually in aluminium cages
- Diet: Special Diet Services Expanded Rabbit Diet
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 21°C
- Humidity: mean 58% - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for one or 2 s. The other eye remained untreated to serve as a control.
- Observation period (in vivo):
- Observations were done 1, 24, 48 and 72 hours after treatment
- Number of animals or in vitro replicates:
- 3 (2 males & 1 female)
- Details on study design:
- Approximately 24 h before test commencement, both eyes of each rabbit were examined for defects. The quantity of material instilled into each treated eye was 100 mg. Instillation of the test material was by the following technique: The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for one or 2 s. The other eye remained untreated to serve as a control.The eyes were examined for irritation using standard illumination. The ocular reaction was recorded at 1, 24, 48 and 72 h after
instillation. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.23
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks:
- score 1 observed in two animals at 24h observation time
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks:
- score 1 observed in one animal one hour after treatment
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 2 days
- Other effects:
- Conjunctival redness, chemosis and discharge were recorded at 1 hour (maximum score was 2 in two animals). By 48 hours all treated eyes were normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be non-irritating to rabbit seyes.
- Executive summary:
The study was performed 1986 as GLP-test following EC-test method B.5. The used species were New Zealand White rabbits; 100 mg test item was instilled in the conjunctival sac of two males and one female. Conjunctival irritation was limited to slight redness and chemosis (score 1) in 1/3 rabbits and moderate redness, chemosis and discharge (score 2) in 2/3 rabbits at 1 h post instillation. After 24 h, slight redness persisted in 2/3 rabbits. By 48 h all treated eyes were normal. In conclusion, P5367 is not irritant to rabbit eyes.
- 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
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The test item was found to be non-irritating in an in-vivo eye irritation study on rabbits performed for new substance notification (ELINCS). Therefore, an in-vitro eye irritation study does not need to be conducted.
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 data available the substance is not classified or labelled according to Regulation 1272/2008/EC (CLP).
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