Registration Dossier
Registration Dossier
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EC number: 277-274-5 | CAS number: 73070-48-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]
- EC Number:
- 277-274-5
- EC Name:
- Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]
- Cas Number:
- 73070-48-1
- Molecular formula:
- C16H41N2O8P (Mono-ester salt); C20H46NO6P (Bis-ester salt)
- IUPAC Name:
- Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]
- Test material form:
- liquid: viscous
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™ reconstructed human epidermis
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: Single topical application of 50µl of neat test item
NEGATIVE CONTROL
- Amount applied: 50µl
- Lot/batch no.: RNBG4913
POSITIVE CONTROL
- Amount applied: 50µl
- Lot/batch no.: SLBD3295V - Duration of treatment / exposure:
- 3 and 60 minutes
- Number of replicates:
- Triplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 27.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 26.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- After a 3- and 60-minute exposure period of EpiDerm™ reconstructed human epidermis to phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol], the registered substance was determined to be corrosive to human skin (Skin Corr. 1B/1C) (CLP Regulation (EC) No. 1272/2008). This classification was based on a resulting tissue viability of 27.1 and 26.5 % after 3 and 60 minutes, respectively.
- Executive summary:
An in vitro experiment was undertaken to determine the skin corrosion potential of phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol] in line with OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method). The study was compliant with GLP. A single topical application of phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol] was applied reconstructed human epidermis Epiderm™ neat at 50 µl. A negative control of tissue grade sterile water and positive control of potassium hydroxide was run in parallel and similarly applied at 50 µl. Epiderm™ was exposed to test and reference items for a 3- and 60-minute period at 37 °C, 5 % CO2, 95 % RH. Following the exposure period and prior to final measurement of the tissue viability, all tissues were rinsed, loaded with MTT (3-[4,5dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide), and extracted in isopropanol. Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are subsequently used to make a prediction of the corrosion potential.
All controls were valid and demonstrated the reliability of the test system. Mean tissue viability, calculated as a percentage of the negative control, was 27.1 % after a 3-minute exposure and 26.5 % after a 60-minute exposure. According to CLP Regulation (EC) No. 1272/2008, phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol] should be regarded as corrosive to human skin and classified as Skin Corr. 1B/1C.
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