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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Primary eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL undiluted
- Duration of treatment / exposure:
- The undiluted test material was placed into one eye of each rabbit. The untreated eye served as control.
- Observation period (in vivo):
- approximately 1 hour and at 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- The eyes were examined and graded for ocular reaction at approximately 1 hour and at 24, 48 and 72 hours after appliecation using the Draize method. Except for the 1 hour scoring, the eyes were scored again for corneal opacity intensity and area using fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
Table 1: Primary Eye Irritation in Rabbits Following an Ocular Application of Test Material
Rabbit | Cornea | Iris | Conjunctivae | Total | ||||
Number | Hr/Day | (Opacity) | (Area) | Erythema | Swelling | Discharge | Score | |
1 | 1 hours | 0 | 0 | 0 | 1 | 1 | 0 | 4 |
(male) | 24 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2/2 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
Mean/An 1 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.33 | 0.00 | |||
2 | 1 hours | 0 | 0 | 0 | 2 | 2 | 0 | 8 |
(male) | 24 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2/2 |
48 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2/2 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
Mean/An 2 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.67 | 0.00 | |||
3 | 1 hours | 0 | 0 | 0 | 1 | 1 | 0 | 4 |
(male) | 24 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
Mean/An 3 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.00 | 0.00 | |||
4 | 1 hours | 0 | 0 | 0 | 2 | 2 | 0 | 8 |
(female) | 24 hours | 0 | 0 | 0 | 1 | 1 | 0 | 4/4 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
Mean/An 4 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.33 | 0.33 | |||
5 | 1 hours | 0 | 0 | 0 | 1 | 1 | 0 | 4 |
(female) | 24 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2/2 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
Mean/An 5 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.33 | 0.00 | |||
6 | 1 hours | 0 | 0 | 0 | 1 | 1 | 0 | 4 |
(female) | 24 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2/2 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0/0 | |
Mean/An 6 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.33 | 0.00 |
The total score is the sum of the following three sub-totals, with a maximum score of 110; (/) = score without/with sodium fluorescein.
1. Decgree of opacity x area x 5
2. Iris score x 5
3. (Sum of scores for erythema, swelling and discharge) x 2
Applicant's summary and conclusion
- Interpretation of results:
- other: The undiluted test material is classified in Toxicity Category III (40 CFR 156.10) by ocular administration.
- Conclusions:
- The primary eye 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.
The test material produced conjunctival irritation, which had cleared by 72 hour reading.
Maximum total irritation scores for individual animals ranged from 4 to 8.
There was no evidence of corrosion noted.
Based on mean scores following grading at 24, 48 and 72 hours after instillation of the test material, TegMeR(R) 804 would not be classified as an eye irritant due to the minimal sores observed for corneal opacity, iritis, conjunctival redness or conjunctival oedema.
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