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EC number: 278-758-9 | CAS number: 77745-66-5
Skin irritation / corrosion
Administrative data
- 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.
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 404 (Acute Dermal 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
- 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.
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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).
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 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.
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