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Registration Dossier
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EC number: 275-063-2 | CAS number: 70955-74-7
Endpoint summary
Administrative data
Description of key information
Data show slight irritation to the skin and eye, which is fully reversible and below the level of classification.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young adult/males 2280-2634 grams at experimental start. The animals were singly housed in suspended stainless steel caging with mesh floors, which conform 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. Animal Room Temperature and Relative Humidity Ranges: 19-23ºC and 42-54%, respectively.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 male
- Details on study design:
- Five-tenths of a milliliter of the undiluted test substance was applied to one 6-cm2 intact dose site on each animal and covered with a 1-inch x 1-inch, 4-ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.
After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 30 min - 72 hr
- Score:
- 0.9
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritant / corrosive response data:
- All animals appeared active and healthy during the study, with one animal losing body weight by the end of the study. There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
For the first 48 hours after patch removal, all three treated sites exhibited very slight erythema and two sites exhibited very slight edema. The overall incidence and severity of irritation decreased over time. All animals were free of dermal irritation by Day 7 (study termination).
The Primary Dermal Irritation Index for triisotridecyl phosphite is 0.9. - 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 slightly irritating to the skin. 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 slightly irritating to the skin. 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.
Reference
Individual dose sites were scored according to the Draize scoring system1 (see Table 4) at approximately 30-60 minutes, 24, 48, and 72 hours and at 7 days after patch removal.
The classification of irritancy was obtained by adding the average erythema and edema scores for the 30-60 minute, 24, 48, and 72-hour scoring intervals and dividing by the number of evaluation intervals (4).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- 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.
- 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. - 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. - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
New testing (Lowe 2014) on TiTDP indicates that it is not a skin and eye irritant. TiTDP was only slightly irritating to the skin and mildly irritating to the eye. These results are similar to those of triisodecyl phosphite (TDP), which is also not a skin and eye irritant, supporting the case that these phosphites have similar mammalian toxicity profiles (see Justification in Section 13).
Justification for selection of skin irritation / corrosion endpoint:
New testing (Lowe 2014) on TiTDP indicates that it is not a skin and eye irritant. TiTDP was only slightly irritating to the skin and mildly irritating to the eye. These results are similar to those of triisodecyl phosphite (TDP), which is also not a skin and eye irritant, supporting the case that these phosphites have similar mammalian toxicity profiles (see Justification in Section 13).
Justification for selection of eye irritation endpoint:
New testing (Lowe 2014) on TiTDP indicates that it is not a skin and eye irritant. TiTDP was only slightly irritating to the skin and mildly irritating to the eye. These results are similar to those of triisodecyl phosphite (TDP), which is also not a skin and eye irritant, supporting the case that these phosphites have similar mammalian toxicity profiles (see Justification in Section 13).
Justification for classification or non-classification
Results from new GLP guideline studies shows slight to mild skin and eye irritation, well below the level of classification.
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