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EC number: 271-708-7 | CAS number: 68604-99-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26-Jul-2017- 10-Oct-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-(dimethoxyphosphoryl)octadecanoic acid 10-(dimethoxyphosphoryl)octadecanoic acid
- Molecular formula:
- C20H41O5P
- IUPAC Name:
- 9-(dimethoxyphosphoryl)octadecanoic acid 10-(dimethoxyphosphoryl)octadecanoic acid
- Reference substance name:
- 9,12-bis(dimethoxyphosphoryl)octadecanoic acid 9,13-bis(dimethoxyphosphoryl)octadecanoic acid 10,12-bis(dimethoxyphosphoryl)octadecanoic acid 10,13-bis(dimethoxyphosphoryl)octadecanoic acid
- Molecular formula:
- C22H46O8P2
- IUPAC Name:
- 9,12-bis(dimethoxyphosphoryl)octadecanoic acid 9,13-bis(dimethoxyphosphoryl)octadecanoic acid 10,12-bis(dimethoxyphosphoryl)octadecanoic acid 10,13-bis(dimethoxyphosphoryl)octadecanoic acid
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Reference substance name:
- Linoleic acid
- EC Number:
- 200-470-9
- EC Name:
- Linoleic acid
- Cas Number:
- 60-33-3
- Molecular formula:
- C18H32O2
- IUPAC Name:
- octadeca-9,12-dienoic acid
- Reference substance name:
- Dimethyl (2-oxopropyl)phosphonate
- EC Number:
- 224-110-5
- EC Name:
- Dimethyl (2-oxopropyl)phosphonate
- Cas Number:
- 4202-14-6
- Molecular formula:
- C5H11O4P
- IUPAC Name:
- dimethyl (2-oxopropyl)phosphonate
- Reference substance name:
- Dimethyl propylphosphonate
- EC Number:
- 242-555-3
- EC Name:
- Dimethyl propylphosphonate
- Cas Number:
- 18755-43-6
- Molecular formula:
- C5H13O3P
- IUPAC Name:
- dimethyl propylphosphonate
- Reference substance name:
- Dimethyl methylphosphonate
- EC Number:
- 212-052-3
- EC Name:
- Dimethyl methylphosphonate
- Cas Number:
- 756-79-6
- Molecular formula:
- C3H9O3P
- IUPAC Name:
- dimethyl methylphosphonate
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
- Specific details on test material used for the study:
- Identification: Fatty acids, C18-unsatd., phosphates.
CAS number: 68604-99-9
EC number: 271-708-7
Appearance: Yellow liquid
Batch: 0101891886
Purity/Composition: 100% UVCB
Test item storage: At room temperature
Stable under storage conditions until: 02 November 2017 (retest date)
Test Facility test item number: 208073/A
Chemical name (IUPAC, synonym or trade name: Phosphorylated fatty acid
pH (1% in water, indicative range): 2.28 – 2.21 (determined by Charles RiverDen Bosch)
Specific gravity / density: 1.04
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- 1 male
- Details on test animals or tissues and environmental conditions:
- Target temperatures of 18 to 24°C with a relative target humidity of 40 to 70% were maintained. The actual daily mean temperature during the study period was 19 to 20°C with an actual daily mean relative humidity of 58 to 90%
12-hour light/12-hour dark cycle was maintained. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms.
Pelleted diet for rabbits (Global Diet 2030 Teklad®, Mucedola, Milanese, Italy) was provided once daily throughout the study. In addition, hay (TecniLab-BMI BV, Someren, The Netherlands) was available during the study period. The feed was analyzed by the supplier for nutritional components and environmental
contaminants. Results of the analysis were provided by the supplier and are on file at the TestFacility.It is considered that there were no known contaminantsin the feed that would interfere withthe objectives of the study.
Municipal tap-water was freely available to each animal via water bottles. Periodic analysis of the water was performed.It is considered that there were no known contaminants in the water that would interfere with the objectives of the study.
For psychological/environmental enrichment, the animal was provided with shelter (Ebeco, Germany, dimensions 40 x 32 x 23 cm) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) except when interrupted by study procedures/activities.
Veterinary care was available throughout the course of the study; however, no examinations or treatments were required.
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel).
One hour prior to instillation of the test item, buprenorphine (Buprenodale®) 0.01 mg/kg was administered by subcutaneous injection in order to provide a therapeutic level of systemic analgesia. Five minutes prior to instillation of the test item, two drops of the topical anaesthetic 0.5% proparacaine hydrochloric ophthalmic solution (Alcaine eye drops®) were applied to botheyes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 21 d
- Details on study design:
- The animal was treated by instillation of 0.1 mL of the test item, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test item. The other eye remained untreated and served as the reference control. Additional injections of buprenorphine 0.01 mg/kg were administered immediately after the 1-hour observation and at the end of the first day to reduce pain and distress.Additional injections of buprenorphine 0.03 mg/kg were supplied approximately 4.5 hours after dosing to reduce pain and distress.Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt,Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. This procedure was repeated to assess recovery. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area. Immediately after fluorescein examination on Day 2, in order to provide a continued level of systemic analgesia, buprenorphine 0.01 mg/kg and meloxicam (Metacam®, Boehringer Vetmed GmbH, Ingelheim/Rhein, Germany) 0.5 mg/kg were administered by subcutaneous injection. Additional injections of buprenorphine 0.01 mg/kg and meloxicam 0.5 mg/kg were administered immediately after the 48-hour observation to reduce pain and distress.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 1
- Irritation parameter:
- other: conjuctivae disharge score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- other: conjuctivae disharge score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Irritation parameter:
- other: conjuctivae disharge score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Irritation parameter:
- other: conjuctivae disharge score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 1
- Irritation parameter:
- other: conjuctivae disharge score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 1
- Irritation parameter:
- other: conjuctivae disharge score
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 1
- Irritant / corrosive response data:
- The corneal injury consisted of opacity and epithelial damage. As a result of the corneal injury, pannus (neovascularization of the cornea) was apparent between 7 and 21 days after instillation. The corneal injury did not completely resolve within 21 days. Iridial irritation was observed and resolved within 72 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and did not completely resolve within 21 days.
Any other information on results incl. tables
Mean value eye irritation scores (mean 24, 48, 72 hours): corneal opacity: 1.0, iris 0.7, conjuctivae redness 3.0, conjuctivae chemosis 2.3.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), Fatty acids, C18-unsatd., phosphates. should be classified as: having irreversible effects on the eyes (Category 1).
- Executive summary:
The objective of this acute eye irritation study was to assess the possible irritation or corrosion potential when a single dose of Fatty acids, C18-unsatd., phosphates. was placed in the conjunctival sac of the rabbit eye. The study was carried out in compliance with the guidelines described in:
• OECD No.405 (2012) "Acute Eye Irritation / Corrosion"
• EC No 440/2008, part B: "Acute Toxicity: Eye Irritation/Corrosion"
• EPA, OPPTS 870.2400 (1998), "Acute Eye Irritation"
• JMAFF Guidelines (2000), including the most recent revisions.
A single sample of 0.1 mL of Fatty acids, C18-unsatd., phosphates. was instilled into one eye of one rabbit. Observations were made 1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation.
Instillation of the test item resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity and epithelial damage. As a result of the corneal injury, pannus (neovascularization of the cornea) was apparent 7, 14 and 21 days after instillation. The corneal injury did not completely resolve within 21 days.
Iridial irritation was observed and resolved within 72 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and did not completely resolve within 21 days.
Based on these results:
• according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), Fatty acids, C18-unsatd., phosphates. should be classified as: having irreversible effects on the eyes (Category 1).
• according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Fatty acids, C18-unsatd., phosphates. should be classified as Irreversible effects on the eye (Category 1) and labeled as H318: Causes serious eye damage.
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