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EC number: 418-310-3 | CAS number: 126050-54-2
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 August 1989 to 16 October 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic Animals, U. S. Environmental Protection Agency Office of Pesticide and Toxic Substances Series 81-5, pp. 55-59, November 1982.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test Material: Mark HP-10
Physical Description: White powder
Purity and Stability: Sponsor assumes responsibility for purity and stability determinations (including under test conditions).
Storage and Retention: The test material was stored at room temperature.
Any unused material will be discarded according to HLA Standard Operating Procedure.
Safety Precautions: Normal handling procedures were used according to HLA Standard Operating Procedure.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test Animal: Adult albino rabbits, Hra:(NZW)SPF, were procured, maintained individually in screen-bottom cages in temperature- and humidity-controlled quarters, provided access to water ad libitum and a measured amount of High Fiber Rabbit Chow® 5326, Purina Mills, Inc., and held for an acclimation period of at least 7 days. Animal husbandry and housing at HLA comply with standards outlined in the "Guide for the Care and Use of laboratory Animals”. If variations from the prescribed environmental conditions existed, they were documented and considered to have no effect on the study outcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study.
Three male and three female acclimated animals, weighing from 2320 to 2436 g, were chosen at random for the test, and maintained during the observation period as specified for the acclimation period. Test animals were identified by animal number and corresponding ear tag.
Reason for Species Selection: Historically, the New Zealand White albino rabbit has been the animal of choice for evaluating the effect of chemicals on the skin.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 0.5 g and moistened with 0.9% saline.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- three males and three females.
- Details on study design:
- Approximately: 24 hours before treatment the hair was clipped from the back and flanks of each animal.
Preparation of Test Material: The sample was dosed as received.
Treatment: The test material was applied to the intact skin of each rabbit in the amount of 0.5 g and moistened with 0.9% saline. The treated area was covered with a 2.5 x 2.5 cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap® and secured with Elastoplast® tape to provide a semiocclusive dressing. Collars were applied to restrain the test animals for the 4-hour exposure period.
Reason for Route of Administration: Historically the dermal route is the route of choice based on the method of Draize.
Observations: After the exposure period, the patches were removed. The test sites were washed using lukewarm tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritating the skin. Thirty minutes following removal of the test material, the degree of erythema and edema was read according to the Draize technique (recorded as the 4-hour score). Subsequent examinations were made at 24, 48 and 72 hours after patch removal.
Individual body weights were taken just prior to study initiation.
Termination: At study termination all animals were euthanatized and discarded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Application of Mark HP-10 to rabbits under 4-hour semi occluded conditions resulted in no dermal irritation in any of the six albino rabbits.
Any other information on results incl. tables
Individual dermal Irritation Scores
Animal Number |
Sex |
Erythema (hour) |
Edema (Hour) |
||||||
4 |
24 |
48 |
72 |
4 |
24 |
48 |
72 |
||
F29514 |
M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F29498 |
M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F29516 |
M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F29517 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F29518 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F29519 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Average Primary Dermal Irritation Scores*
Observation Period (Hour) |
Average Score |
4 |
0.0 |
24 |
0.0 |
48 |
0.0 |
72 |
0.0 |
*The average primary dermal irritation score is the total dermal irritation score for all the animals (erythema and edema) divided by the number of test sites at each observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Application of Mark HP-10 to rabbits under 4-hour semi occluded conditions resulted in no dermal irritation in any of the six albino rabbits. The average of the 4-, 24-, 48-, and 72-hour scores is 0.0 (considered to be non irritating).
- Executive summary:
To assess the relative level of primary skin irritation of a test material on rabbits under semi occluded conditions according to the U. S. Environmental Protection Agency's Guidelines for Testing Pesticides and Toxic Substances.
Regulatory Compliance: This study was conducted in accordance with the U.S. Environmental Protection Agency Good laboratory Practice Standards, 40 CFR 792 (November 29, 1983), the Food and Drug Administration Good Laboratory Practice Regulati9ns, 21 CFR 58, and the proposed Organisation for Economic Cooperation and Development's Principles of Good Laboratory Practice,
Annex 2, C(81)30. The in-life portion of the study was done before the effective date of the revised EPA standards (September 18, 1989).
The test material, Mark HP-10, was evaluated for its primary dermal irritation potential in male and female albino rabbits. The test material produced no dermal reactions at any of the observations. The average of the 4-, 24-, 48-, and 72-hour scores is 0.0 (considered to be non irritating).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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