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EC number: 947-719-4 | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 October 1987 to 30 October 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure to test material took place over 24 hours and reversibility of skin reactions was not investigated
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phosphoric acid, butyl ester, potassium salt
- EC Number:
- 258-379-5
- EC Name:
- Phosphoric acid, butyl ester, potassium salt
- Cas Number:
- 53126-06-0
- Molecular formula:
- KO4P
- IUPAC Name:
- Potassium butyl hydrogen phosphate
- Test material form:
- solid - liquid: aqueous solution
- Details on test material:
- Phosphoric acid, n-butyl ester, potassium salt (1.37 ester groups per molecule)
Constituent 1
- Specific details on test material used for the study:
- - Physical form: Colourless to light amber liquid
- Purity: 50 % active ingredient
- Lot: 369
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- male
- Details on test animals or test system and environmental conditions:
- ANIMAL HUSBANDRY
- Young adult male and female New Zealand White rabbits were received from Hare Marland, Hewitt, New Jersey.
- Rabbits were housed singly in suspended, stainless steel, wire-mesh cages.
- Each rabbit was assigned a unique identification number which was recorded on a card affixed to the cage.
- Purina Certified Rabbit Chow #5322 and water were available ad libitum except during the 24-hour period when exposure to test material took place.
- Rabbits were weighed and observed for general health for approximately two weeks.
- Animal rooms were maintained on a timer-controlled 12-hour light and 12-hour dark cycle.
- Target environmental conditions of the animal rooms were 20 ± 2 °C with relative humidity of 50 ± 10 %. Any excursions outside these ranges were of small magnitude and/or brief duration and did not adversely affect the validity of the study.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Six
- Details on study design:
- PROTOCOL
- On the day prior to study initiation, the hair of six male rabbits was closely clipped to expose the skin from the scapular to the lumbar region of the back.
- Rabbits weighed 2625 to 3130 g on the day of treatment.
- Each rabbit was placed into a stock which had been fitted with a piece of rubber sheeting approximately 8" x 18 ".
- Rabbits remained in the stocks throughout the exposure period and did not have access to food or water during that time.
- An aliquot (0.5 mL) of test material was applied directly onto the test site beneath a 1" gauze square that was held in place with tape.
- The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test material in contact with the skin without undue pressure.
- Three other test materials were applied to three other sites on the same animal.
- Approximately 24 hours after application of the test material, the rubber sheeting was loosened and the skin at the corners of the gauze squares was marked with a waterproof pen. Wrappings were then removed.
- The test sites were gently washed with warm water to remove excess test material.
- The skin was gently patted dry and the animals were returned to their cages.
- Approximately 24, 48 and 72 hours after application of the test material, the test sites were evaluated for erythema, edema and other evidence of dermal effects.
- The test sites were scored according to the Draize scale (see Table 1, attached). Adjacent areas of skin were used for comparison.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Animal 21955
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Animal 21956
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Animal 21957
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Animal 21958
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Animal 21959
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Animal 21960
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Animal 21955
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Animal 21956
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Animal 21957
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Animal 21959
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Animal 21960
- Irritant / corrosive response data:
- - By 24 hours following treatment, the test item produced severe erythema with moderate edema in one rabbit and moderate erythema with slight edema in five rabbits.
- By 48 hours following treatment, one rabbit exhibited moderate erythema with slight edema and five rabbits exhibited slight or mild erythema with no edema.
- The skin irritation had subsided by 72 hours with slight erythema being observed in five rabbits.
- A summary of skin responses to test material is attached.
- Individual skin responses following exposure to test material are shown in Table II (attached).
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Following exposure to test material for 24 hours and grading at 24, 48 and 72 hours, the mean scores for erythema were ≥ 2.3 in 1/6 rabbits and the mean scores for edema were < 2.3 in 6/6 animals. Study duration did not permit demonstration of full reversibility of skin irritation in all animals.
- Executive summary:
In a study similar to OECD 404, the test material was evaluated for acute skin irritation in six male rabbits after 24 hours exposure to the substance under occlusive conditions. Severe erythema with moderate edema was seen in one rabbit and moderate erythema with slight edema in five rabbits at 24 hours after treatment. By 48 hours, one rabbit exhibited moderate erythema with slight edema and five rabbits exhibited slight or mild erythema with no edema. Following grading at 24, 48 and 72 hours, the mean scores for erythema were ≥ 2.3 in 1/6 rabbits and the mean scores for edema were < 2.3 in 6/6 animals. The results do not provide evidence of skin corrosivity but study duration did not permit demonstration that skin irritation would be fully reversible in all animals.
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