Registration Dossier
Registration Dossier
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EC number: 302-766-4 | CAS number: 94134-01-7
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
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:
- N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)
- EC Number:
- 302-766-4
- EC Name:
- N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)
- Cas Number:
- 94134-01-7
- Molecular formula:
- C6H9NO6.3C2H7NO
- IUPAC Name:
- 2-[bis(carboxymethyl)amino]acetic acid; tris(2-aminoethan-1-ol)
- Test material form:
- solid: bulk
Constituent 1
In vitro test system
- Test system:
- human skin model
- 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: ~8mm disc (50 mg) prior to wetting of the tissue with 15 µl water
NEGATIVE CONTROL
- Amount applied: 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:
- 82.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 22.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the reported study, mean tissue viability (as a percentage of the negative control) was 22.6 % after a 60-minute exposure and 82.7 % after a 3-minute exposure. N,N’-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3) does not meet the criteria for classification according to CLP Regulation (EC) No. 1272/2008
- Executive summary:
A GLP-compliant study was performed to determine the skin corrosion potential of N,N’-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3) in line with OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method). N,N’-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3) was applied as a ~8 mm disc (50 mg) to reconstructed human epidermal tissue (Epiderm™) prior to wetting with 15 µl of water. Negative controls of tissue grade sterile water and positive controls of potassium hydroxide were prepared and applied at 50 µl. Exposure was permitted for a 3- and 60-minute period at 37 °C, 5 % CO2, 95 % RH. Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are then used to make a prediction of the corrosivity potential of the test item. All controls were valid and demonstrated the reliability of the test system. Mean tissue viability (as a percentage of the negative control), was 82.7 and 22.6 % after 3 and 60 minutes of exposure, respectively. Therefore, N,N’-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3) does not meet the criteria for classification according to CLP Regulation (EC) No. 1272/2008.
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