Registration Dossier
Registration Dossier
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EC number: 221-088-9 | CAS number: 3001-98-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-06-17 until 2015-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: per guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- the deviation from SOP didn't impact the result of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
- EC Number:
- 221-088-9
- EC Name:
- 3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
- Cas Number:
- 3001-98-7
- Molecular formula:
- C7H14O6P2
- IUPAC Name:
- 3,9-dimethyl-2,4,8,10-tetraoxa-3λ⁵,9λ⁵-diphosphaspiro[5.5]undecane-3,9-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- AFLAMMIT® PCO 962
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: SkinEthic Reconstituted Human Epidermis (RHE)
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- Upon delivery, SkinEthic™ tissues (RHE/S/17) were treated according to the SOP.
At day 18, tissues were transferred to growth culture medium .Tissues were placed in
maintenance culture medium prior to application of test substances.
Test system
- Details on study design:
- The irritant potential of AFLAMMIT® PCO 962 was tested using the SkinEthic™ RHE model and expressed as a percent of the negative control tissue NC (exposed to Phosphate Buffer Saline, PBS).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- > 50
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
| Treatment | Assay acceptance criterion | OD 570nm1 | SD2 |
| PBS (NC) | 0.8 <= OD <= 3 | 1.689 | 0.122 |
| SDS (PC) | - | 0.020 | 0.001 |
| AFLAMMIT® PCO 962 | - | 1.790 | 0.041 |
| Treatment | Assay acceptance criterion | Viability %l | SD %2 | I/NI3 |
| PBS (NC) | SD <= 18% | 100.0 | 7.22 | NI |
| SDS (PC) | SD <= 18% and Viability < 40% |
1.2 |
0.03 |
I |
AFLAMMIT® PCO 962 |
SD <= 18% |
106.0 |
2.42 |
NI |
1: mean of 3 replicates
2: SD: Standard Deviation
3: I: Irritant; NI: Non Irritant
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The viability of the RHE in the presence of the test substance was above 50% at 42 minutes exposure and 42 hours recovery, following analysis by the MTT viability assay.
Therefore, the sample was classified as non-irritant.
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