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EC number: 242-149-6 | CAS number: 18268-70-7
- 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
- Remarks:
- Primary skin irritation study in rabbits
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 18 1992 to December 8 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- A study conducted under Good Laboratory Practice Standards (40 CFR) and conforming with internationally recognized protocols and in particular satisfying criteria of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and OECD Guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: The protocol satisfies the criteria established by the Federal Insecticide, Fungicide, and Ro denticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.
- Deviations:
- no
- Principles of method if other than guideline:
- Young adult, male and female New Zealand White rabbits were used. The test material was administered as received.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- All aspects of this study, as defined in the Protocol and the Project Instruction Sheet, were conducted in accordance with Good Laboratory Practice Standards (40 CFR).
Test material
- Reference substance name:
- 3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
- EC Number:
- 242-149-6
- EC Name:
- 3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
- Cas Number:
- 18268-70-7
- Molecular formula:
- C24H46O7
- IUPAC Name:
- 3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
Constituent 1
- Specific details on test material used for the study:
- The test material was a clear, golden-yellow liquid and was stored at room temperature throughout the study in two clear, glass jars.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young adult male and female New Zealand White rabbits were used. The animals were purchased from a U.S.D.A. approved supplier.
All animals were acclimated to the laboratory for one day before use. Animals were housed singly in wire mesh suspension cages and were supplied PURINA LABORATORY RABBIT CHOW (or other comparable diet) and tap water ad libitum except for the withholding of food overnight prior to dosing. The animals were maintained in 12-hour light/12-hour dark cycles.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male and 3 female
- Details on study design:
- On the day prior to the dosing the application sites were prepared by clipping the hair from the dorsal surface of each animal.
A 0.5 gram aliquot of the undiluted test material was applied to to each animal under a one inch X one inch gauze patch, two layers thick. Each patch was held in place with adhesive tape. After application of the patch, the trunk of each animal was wrapped with rubber dental dam and this secured with staples. An outer layer of gauze was wrapped around the trunk of each animal and secured with tape. Each animal was fitted with an appropriate restraining device to prevent wrapping and patch removal. Following approximately 4 hours of exposure, the wrapping and patches were removed. The test sites were wiped free of residual test material by gentle sponging using a moistened towel.
The application sites were scored for each rabbit according to Draize at approximately 1/2 to 1 hour, 24 hours, 48 hours and 72 hours. Any other notable responses were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Hair on site and minor desquamation at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Hair on site and minor desquamation at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Hair on site and minor desquamation at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Hair on site at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Hair on site at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Hair on site at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Minor desquamation at site at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Minor desquamation at site at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Remarks:
- Minor desquamation at site at 168 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Skin Irritation Test Ref.: 92-8820-21 C | |||
Intact Skin | |||
Rabbit No. | Erythema Score | Oedema Score | Comments |
/Observation Time | |||
No. 1 | |||
1 hour | 2 | 2 | Hair on site |
24 hour | 2 | 2 | Hair on site |
48 hour | 2 | 2 | Hair on site |
72 hour | 1 | 0 | Hair on site |
168 hour | 0 | 0 | Hair on site - Desq. |
Mean 24,48, 72 | 1.67 | 1.33 | |
No. 2 | |||
1 hour | 1 | 1 | |
24 hour | 2 | 1 | |
48 hour | 1 | 1 | |
72 hour | 1 | 0 | |
168 hour | 0 | 0 | |
Mean 24,48, 72 | 1.33 | 0.67 | |
No. 3 | |||
1 hour | 2 | 2 | Hair on site |
24 hour | 2 | 2 | Hair on site |
48 hour | 2 | 1 | Hair on site |
72 hour | 1 | 0 | Hair on site |
168 hour | 0 | 0 | Hair on site |
Mean 24,48, 72 | 1.67 | 1.00 | |
No. 4 | |||
1 hour | 2 | 2 | |
24 hour | 2 | 1 | |
48 hour | 2 | 1 | |
72 hour | 2 | 1 | Desq. At site |
168 hour | 0 | 0 | Desq. At site |
Mean 24,48, 72 | 2.00 | 1.00 | |
No. 5 | |||
1 hour | 1 | 1 | |
24 hour | 2 | 2 | |
48 hour | 2 | 1 | |
72 hour | 0 | 0 | |
168 hour | 0 | 0 | |
Mean 24,48, 72 | 1.33 | 1.00 | |
No. 6 | |||
1 hour | 2 | 1 | |
24 hour | 2 | 1 | |
48 hour | 1 | 0 | |
72 hour | 0 | 0 | |
168 hour | 0 | 0 | |
Mean 24,48, 72 | 1.00 | 0.33 |
For each rabbit, erythema and eschar formation scores were recorded at 1/2 to 1 hours, 24 hours, 48 hours and 72 hours and these values totaled for each rabbit. The eight averaged scores from this were added together and the sum divided by 4 to obtain a Primary Irritation Index (PII).
Applicant's summary and conclusion
- Interpretation of results:
- other: Category III accordiing to 40 CFR 156.10
- Remarks:
- Moderate irritation at 72 hours.
- Conclusions:
- The primary skin irritancy of undiluted test material was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.
Moderate irritation persisted 72 hours following applications. All animals were held for 7 days at which time all irriatation had cleared.
The Primary Irritation Index (PII) was found to be 2.8 based on erythema and edema.
The only change noted in the coloration and/or texture of the skin was desquamation that persisted in 2 of the 6 test animals.
No evidence of corrosion was found.
Based on mean 24, 48 and 72 hour scores for erythema/eschar or for oedema, TegMeR(R) 804 would not be classified as a skin irritant under the EU CLP Regulation.
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