Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 271-517-9 | CAS number: 68583-52-8
- 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:
- July 19, 1995 to October 13, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Version / remarks:
- July 1, 1991
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
- EC Number:
- 271-517-9
- EC Name:
- Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
- Cas Number:
- 68583-52-8
- Molecular formula:
- C10-H20-O2.C8-H16-O2.C6-H14-O4
- IUPAC Name:
- Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
Constituent 1
- Specific details on test material used for the study:
- The test substance was received from the C.P. Hall Company on July 5, 1995. The BIN number was 024910
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six (3M:3F) New Zealand white rabbits, weighing approximately 1.5 - 2.0 kilograms and about three (3) months of age, were obtained from Davidson Mill Breeding Labs, Jamesburg, NJ. The animals were checked carefully upon receipt for ocular defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general condition.
Animals were acclimated for five (5) days prior to test initiation. They were housed in stainless steel cages, in a room with a 12 hour light/dark cycle. The room temperature was controlled to comply with Animal Welfare regulations with an approximate range of 65° to 75° F. The humidity was also monitored. The animals were identified through individual ink markings on the outer ear of each animal, as well as a cage label. Diet consisted of Lab Diet Certified Rabbit Diet #5322, as well as water, ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The contralateral eye (untreated) served as control.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The eyes of the animals remained unwashed for the duration of the study (72 hours)
- Observation period (in vivo):
- Up to 21 days or until all signs of reversible irritation subsided.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- In the technique of determining toxicity of substances to ocular mucosa, observation of injuries was made on the cornea, iris, and the bulbar and palpebral conjunctivae. Numerical scores were assigned to lesions observed according to the Draize scale. (Refer to appended table). In this
system of scoring, the injuries to the cornea and iris account for approximately 80% of the score; these structures are purposely weighted because of their vital role in vision. The presence of lesions not described in the Draize scale was also noted.
All eyes were examined with fluorescein sodium within 24 hours prior to initiation for ocular defects not visible to the naked eye. Immediately prior to test initiation, the animals were momentarily restrained. A dose of one-tenth (0.1) of a milliliter of the test article was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The eyelids were gently held together for one (1) second. The contralateral eye, remaining untreated, served as a control. The eyes of the animals remained unwashed.
Observations of ocular irritation were recorded 1, 24, 48 and 72 hours following instillation of the test article. Additional readings were made at 4, 7, 10, 14, 18 and 21 days or until all signs of reversible irritation subsided. Readings were made utilizing a hand held ophthalmoscope. All eyes were examined with fluorescein sodium after dosing, until no retention was observed. Bodyweights were recorded prior to initiation and at termination of the study.
Daily scores were determined for each animal using the weighting system described in the Draize scale. Mean daily scores were determined.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Average Draize score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Average Draize score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Average Draize score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Average Draize score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Average Draize score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0.3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Average Draize score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Other effects:
- No anaimals showed fluorescein retention at either 24 or 48 hours
Any other information on results incl. tables
Primary Ocular Irritation Results
Rabbit | Cornea | Iris | Conjunctivae | Total | ||||
Number | Hr/Day | (Opacity) | (Area) | Erythema | Swelling | Discharge | Score | |
1 | 1 hours | 0 | 0 | 0 | 2 | 0 | 0 | 4 |
(male) | 24 hours | 0 | 0 | 0 | 2 | 0 | 0 | 4 |
48 hours | 0 | 0 | 0 | 2 | 0 | 0 | 4 | |
72 hours | 0 | 0 | 0 | 2 | 0 | 0 | 4 | |
96 hours | 0 | 0 | 0 | 2 | 0 | 0 | 4 | |
7 days | - | - | - | - | - | - | - | |
Mean/An 1 | (24,48 and 72 hr) | 0.00 | 0.00 | 2.00 | 0.00 | |||
2 | 1 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
(male) | 24 hours | 0 | 0 | 0 | 2 | 0 | 0 | 4 |
48 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
72 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
96 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean/An 2 | (24,48 and 72 hr) | 0.00 | 0.00 | 1.33 | 0.00 | |||
3 | 1 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
(male) | 24 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
96 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7 days | 0 | - | - | - | - | - | - | |
Mean/An 3 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.67 | 0.00 | |||
4 | 1 hours | 0 | 0 | 0 | 2 | 0 | 0 | 4 |
(female) | 24 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
96 hours | - | - | - | - | - | - | - | |
7 days | - | - | - | - | - | - | - | |
Mean/An 4 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.33 | 0.00 | |||
5 | 1 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
(female) | 24 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
96 hours | - | - | - | - | - | - | - | |
7 days | - | - | - | - | - | - | - | |
Mean/An 5 | (24,48 and 72 hr) | 0.00 | 0.00 | 0.00 | 0.00 | |||
6 | 1 hours | 0 | 0 | 0 | 2 | 0 | 0 | 4 |
(female) | 24 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
48 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
72 hours | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
96 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7 days | - | - | - | - | - | - | - | |
Mean/An 6 | (24,48 and 72 hr) | 0.00 | 0.00 | 1.00 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to 40 CFR 798.4500 (July 1, 1991) and under the conditions of this test, this test article is minimal ocular irritant. All animals returned to normal before seven (7) days.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.