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EC number: 431-090-3 | CAS number: 190085-41-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 April 1996 to 19 April 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Although conducted by a test method and following good laboratory procedures of the US FDA, there were several inconsistencies noted. The study protocol was not approved by the Sponsor prior to conduct of the study. The Study Director did not sign the study protocol. The study was not inspected by the Quality Assurance Unit during the progress of the study. The study was not conducted for sufficient time to determine reversibility of effects, although, after 72 hours effects observed were only minimal to mild. The dates of study conduct and final signed report dates differ by nearly 2 years.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Hazardous Substance Act, 16 CFR 1500.41
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- deviations: the study protocol was not approved by the Sponsor or signed by the Study Director; the study was not inspected by the Quality Assurance Unit during it progress.
Test material
- Reference substance name:
- -
- EC Number:
- 431-090-3
- EC Name:
- -
- Cas Number:
- 190085-41-7
- Molecular formula:
- C19 H30 O3
- IUPAC Name:
- 2-butyloctyl 2-hydroxybenzoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A USDA licensed supplier
- Age at study initiation: not supplied
- Weight at study initiation: not supplied
- Housing: Animals were randomly assigned to cages on arrival and were housed individually in suspended stainless steel cages, six cages to a unit, in an environmentally controlled room.
- Diet (ad libitum): Agway Prolab High Fiber 5P25 Rabbit feed, alfalfa cubes
- Water (ad libitum): city tap water
- Acclimation period: at least 4 days prior to the start of testing
IN-LIFE DATES: From: 16 April 1996 To: 19 April 1996
Test system
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The sample was dosed by volume (0.5 ml) as received with a sterile syringe.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- The skin was graded for dermal irritation at 24 and 72 hours after administration.
- Number of animals:
- 6
- Details on study design:
- Site Preparation
Animals were clipped free of fur at the test site with Oster(TM) electric clippers. On the right side of the test site a 21 gauge needle was used to make three 2-3 cm long longitudinal abrasions through the stratum corneum but not so deep as to disturb the dermal or cause bleeding (abraded). The left side was left intact.
Application
The test substance was applied to both intact and abraded skin, and each area was covered with a 1 inch square gauze patch. The entire area was covered with plastic wrap and over-wrapped with Elastikon tape to ensure contact of the test substance with the skin and to prevent ingestion of the test substance.
The skin was exposed for a period of 24 hours after which the patch and any residual material was removed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 and 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks:
- 48h observation not performed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 72h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 72h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 72h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 72h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 72h
Any other information on results incl. tables
Primary Rabbit Skin Irritation Scores
Erythema & Eschar Formation | Reading(Hours) | Rabbit No.1 | 2 | 3 | 4 | 5 | 6 | Average |
Intact Skin | 24 | 2 | 1 | 2 | 2 | 2 | 2 | 1.83 |
72 | 1 | 1 | 1F | 1F | 1 | 1 | 1.00 | |
Abraded Skin | 24 | 2 | 2 | 2 | 2B | 2 | 2 | 2.00 |
72 | 1 | 1 | 2F | 2F | 1 | 1 | 1.33 | |
Subtotal | 6.16 |
B = Blanching F = Flaking
Edema Formation | Reading(Hours) | Rabbit No.1 | 2 | 3 | 4 | 5 | 6 | Average |
Intact Skin | 24 | 1 | 0 | 1 | 1 | 1 | 1 | 0.86 |
72 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Abraded Skin | 24 | 1 | 1 | 1 | 2 | 1 | 1 | 1.17 |
72 | 0 | 0 | 1 | 1 | 0 | 0 | 0.33 | |
Subtotal | 2.33 |
Primary Irritation Score = (6.16 + 2.33) / 4 = 8.49 / 4 = 2.12
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a primary dermal irritant
- Remarks:
- Criteria used for interpretation of results: other: US Federal Hazardous Substances Act 16 CFR 1500.3(c)(4)
- Conclusions:
- The test material would not be considered a primary dermal irritant as defined by the Federal Hazardous Substance Act 16 CFR 1500.3 (c) (4) because it did not induce skin reactions with a primary irritation score of 5 or greater.
The test material is not irritating to intact skin according to the EU Directive 67/548/EEC as mean scores for either erythema and eschar formation or edema for intact skin either averaged over all animals or individually did not equal or exceed 2. No labeling is required.
The test material is not classified according to GHS criteria based on mean overall erythema and eschar formation scores for intact skin of = 2.3 for all observation times and for all animals. - Executive summary:
The test article, C.P. Hall Company's sample of RX-13643, lot B.N. YZH012396, was dosed as supplied in accordance with the method described in the Federal Hazardous Substance Act (USA) 16 CFR 1500.41. It produced very slight to well-defined erythema and very slight to well-defined edema. One animal had blanched skin at a test site; two animals had flaking skin. The Primary Irritation Score was 2.12.
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