Registration Dossier
Registration Dossier
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EC number: 278-758-9 | CAS number: 77745-66-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- Triisotridecyl phosphite
- EC Number:
- 278-758-9
- EC Name:
- Triisotridecyl phosphite
- Cas Number:
- 77745-66-5
- Molecular formula:
- C39H81O3P
- IUPAC Name:
- tris(2-methylnonacosyl) phosphite
- Test material form:
- other: liquid
- Details on test material:
- Triisotridecyl phosphite
Lankromark LE571
Batch: W024077 (3284/047)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 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 2% ophthalmic fluorescein sodium 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" (see Table 3). Three healthy naive animals (not previously tested) without pre-existing ocular irritation were selected for test.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye untreated; control eye
- Amount / concentration applied:
- 0.1 mL (undiluted)
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male
- Details on study design:
- One-tenth of a milliliter of the undiluted test substance was 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 Draize et al.1 (see Table 3) 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.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 0-72 hours
- Score:
- 8
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- 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 pharmacologic effects, or abnormal behavior.
There was no corneal opacity or iritis observed in any treated eye during this study. One hour after test substance instillation, all three treated eyes exhibited positive conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72 hours.
The Maximum Mean Total Score for the eye irritation of triisotridecyl phosphite is 8.0.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, triisotridecyl phosphite is found to be mildly irritating to the eye. According to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required. In accordance with the provisions of Regulation (EC) Number 1272/2008 amended by Commission Regulation (EU) Number 286/2011 of 10 March 2011 (ATP002) on the Classification, Labeling, and Packaging of Substances and Mixtures, classification is not required based on the results of this study.
- Executive summary:
Under the conditions of this study, triisotridecyl phosphite is found to be mildly irritating to the eye. According to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required. In accordance with the provisions of Regulation (EC) Number 1272/2008 amended by Commission Regulation (EU) Number 286/2011 of 10 March 2011 (ATP002) on the Classification, Labeling, and Packaging of Substances and Mixtures, classification is not required based on the results of this study.
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