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EC number: 701-338-8 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2015- October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-[(2E)-octadec-2-en-1-yl]dihydrofuran-2,5-dione
- Cas Number:
- 1628163-42-7
- Molecular formula:
- C22H38O3
- IUPAC Name:
- 3-[(2E)-octadec-2-en-1-yl]dihydrofuran-2,5-dione
- Reference substance name:
- 3-[(2Z)-octadec-2-en-1-yl]dihydrofuran-2,5-dione
- Molecular formula:
- C22H38O3
- IUPAC Name:
- 3-[(2Z)-octadec-2-en-1-yl]dihydrofuran-2,5-dione
- Reference substance name:
- 3-(octadecenyl)dihydrofuran-2,5-dione excluding 3-(2-octadecen-1-yl)dihydrofuran-2,5-dione
- Molecular formula:
- C22H38O3
- IUPAC Name:
- 3-(octadecenyl)dihydrofuran-2,5-dione excluding 3-(2-octadecen-1-yl)dihydrofuran-2,5-dione
- Reference substance name:
- Hexadecenylsuccinic anhydride
- EC Number:
- 250-911-4
- EC Name:
- Hexadecenylsuccinic anhydride
- Molecular formula:
- C20H34O3
- IUPAC Name:
- 3-(hexadecenyl)dihydrofuran-2,5-dione
- Reference substance name:
- 3-icosenylsuccinic anhydride
- EC Number:
- 258-603-1
- EC Name:
- 3-icosenylsuccinic anhydride
- Molecular formula:
- C24H42O3
- IUPAC Name:
- 3-icosenyldihydrofuran-2,5-dione
- Reference substance name:
- Side products from the reaction of octadec-1-ene and maleic anhydride
- Molecular formula:
- Not applicable - UVCB component
- IUPAC Name:
- Side products from the reaction of octadec-1-ene and maleic anhydride
- Reference substance name:
- C16-20 (even numbered) alkenes (branched and linear)
- Molecular formula:
- C16H32, C18H36, C20H40
- IUPAC Name:
- C16-20 (even numbered) alkenes (branched and linear)
- Reference substance name:
- Maleic anhydride
- EC Number:
- 203-571-6
- EC Name:
- Maleic anhydride
- Cas Number:
- 108-31-6
- Molecular formula:
- C4H2O3
- IUPAC Name:
- furan-2,5-dione
- Test material form:
- solid
- Details on test material:
- off-white solid, amber liquid at 80 °C. Expected to be stable for duration of testing; Expiration date: not applicable.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- Specific details on test material used for the study:
- As a result of increasingly rigorous criteria being applied to the analysis of commercial material used in physical property/toxicity testing, the identity of the material has been modified to reveal a more accurate and precise depiction of the commercial substance. This enhancement is reflected in changes in chemical identifiers such as EC and/or CAS numbers from those noted in earlier versions of data records or in study reports.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals: Females, 13-16 weeks of age, 2521-3028 g in weight at beginning of the experiment. Obtained from Robinson Services Inc. (supplier).
Housing: The animals were singly housed in suspended stainless steel caging which conforms
to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g.,toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
Temperature: 20-23 degrees C, Humidity: 54-60%
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 12 or 47 days
Food: EnvigoTeklad Global High Fiber Rabbit Diet®#2031, 150 g/day provided to each animal, along with a Premium Timothy Cube(TM) (Ontario Dehy Inc.).
Water: Filtered tap water was supplied ad libitum
.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- One-tenth of a milliliter (0.042 grams) of the test substance was instilled into the eye. The test substance was ground into fine pieces using a spatula.
- Duration of treatment / exposure:
- 0.042 grams of the test substance was instilled into the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. Observations were then taken over the next 72 hours.
- Observation period (in vivo):
- Ocular irritation was evaluated using a white light source in accordance with the Draize method of scoring 1, 24, 48, and 72 hours post-instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Prior to test initiation, both eyes of a group of animals were examined using a white light source and a fluorescein dye procedure. One drop of ophthalmic fluorescein sodium dye was instilled into both eyes of each rabbit. The eyes were rinsed with physiological saline (0.9% NaCl) after instillation of the fluorescein and then evaluated for corneal damage using an ultraviolet light source. Prior to test substance instillation, the eyes were re-examined and scored for abnormalities according to the "Scale for Scoring Ocular Lesions" (Draize et al., 1944). Three healthy, naive animals (not previously tested) without pre-existing ocular irritation were selected for test.
A systemic analgesic (Buprenorphine SR®) was administered to relieve potential discomfort associated with eye irritation which provides therapeutic relief for periods of up to 76 hours. Prior to test substance instillation, 0.1 mg/kg of body weight of the analgesic was administered to the animals and at appropriate intervals to maintain therapeutic blood levels.
The test substance, as received, was a solid. Attempts to grind the test substance with a mortar and pestle prior to instillation were unsuccessful. The test substance was ground into fine pieces using a spatula.
Prior to instillation, 1-2 drops of ocular anesthetic (Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%) were placed into both the treated and control eye of each animal.
One-tenth of a milliliter (0.042 grams) of the test substance was then instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control. The rabbits were then returned to their designated cages.
Ocular irritation was evaluated using a white light source in accordance with the Draize method of scoring (Draize et al., 1944) at 1, 24, 48, and 72 hours post-instillation. The fluorescein dye evaluation procedure described in Section 5.A. was used in the treated eye at 24 hours to verify the absence of corneal damage. Individual scores were recorded for each animal. In addition to observations of the cornea, iris and conjunctivae, any other observed lesions were noted. The average score for all rabbits at each scoring period was calculated to aid in data interpretation.
The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra (Kay & Calandra, 1962).
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period.
Individual weights of animals were recorded shortly before instillation of the test substance (initial) and at the completion of testing (terminal). Additional body weights were taken to determine the appropriate amount of analgesic. These additional body weights were recorded in the raw data but are not reported.
Once testing was complete, the animals were released for euthanasia and humanely euthanized.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- #3401
- Time point:
- 24 h
- Score:
- 8
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- #3401
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- #3401
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Remarks:
- #3402
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Remarks:
- #3402
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Remarks:
- #3402
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Remarks:
- #3403
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Remarks:
- #3403
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no corneal opacity or iritis observed in any treated eye during this study. One hour after test substance instillation, two treated eyes exhibited conjunctivitis and one treated eye exhibited minimal conjunctivitis. The overall incidence and severity of irritation decreased with time. Two of three animals were free of ocular irritation at 48 hours, and all animals, by 72 hours.
- Other effects:
- All animals appeared active and healthy and gained body weight during the study. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse clinical effects, or abnormal behavior.
Any other information on results incl. tables
|
Rabbit No.: 3401 (Female)
|
Rabbit No.: 3402 (Female)
|
Rabbit No.: 3403 (Female)
|
|||||||||
Hour |
Hour |
Hour |
||||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
|
I. Cornea |
|
|
|
|
|
|
|
|
|
|
|
|
A. Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II. Iris |
|
|
|
|
|
|
|
|
|
|
|
|
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Ax5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
III. Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
A. Redness |
2 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
B. Chemosis |
4 |
3 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C. Discharge |
2 |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
3 |
1 |
0 |
0 |
(A+B+C)x2 |
16 |
8 |
0 |
0 |
8 |
2 |
4 |
0 |
8 |
2 |
0 |
0 |
Total |
16 |
8 |
0 |
0 |
8 |
2 |
4 |
0 |
8 |
2 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Mean scores for conjunctival redness and chemosis were < 2. Criteria used for interpretation of results: OECD GHS
- Conclusions:
- n-ODSA EC 701-338-8 is not considered irritating to the eyes, although mild conjunctivitis was observed in rabbits which resolved by 72 hours after dosing.
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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