Registration Dossier
Registration Dossier
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EC number: 805-659-5 | CAS number: 848820-98-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - April 2014
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- butyl 3-{9-oxo-8-oxa-9λ⁵-phosphatricyclo[8.4.0.0²,⁷]tetradeca-1(14),2(7),3,5,10,12-hexaen-9-yl}propanoate
- Cas Number:
- 848820-98-4
- Molecular formula:
- C19H21O4P
- IUPAC Name:
- butyl 3-{9-oxo-8-oxa-9λ⁵-phosphatricyclo[8.4.0.0²,⁷]tetradeca-1(14),2(7),3,5,10,12-hexaen-9-yl}propanoate
- Reference substance name:
- 805-659-5
- EC Number:
- 805-659-5
- IUPAC Name:
- 805-659-5
- Test material form:
- liquid: viscous
- Details on test material:
- Name: KCCS DOB11
Batch no.: DOB11-1301
Test material form: yellow to brown viscous liquid
Composition: 6H-Dibenz[c,e][1,2]oxaphosphorin-6-propanoic acid, butyl ester, 6-oxide (DOB11) ca. 97.7%; 10-Hydroxy-9,10-Dihydro-9-oxa-10-phosphaphenantrene-10-oxide (DOPO-Ox) ca. 0.7%; Butylacrylat ca. 0.2%; o-Cyclohexylphenol ca. 0.1%; others unknown
CAS No.: 848820-98-4
EINECS-No.: 805-659-5
Molecular formula: C19H21O4P
Molecular weight: 344.34 g/mol
Purity: 97.7% GC
Homogeneity: homogenous liquid
Production date: 12. Dec. 2013
Expiry date: 12. Dec. 2014
Storage: Room Temperature: (20 ± 5°C)
Constituent 1
Constituent 2
Test system
- Type of coverage:
- other: Commercially available Epi-200-Kit
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: erythema score
- Value:
- >= 1
- Remarks on result:
- other:
- Remarks:
- Time point: 2014. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Three tissues of the human skin model EpiDermTMwere treated with KCCS DOB11 for 60 minutes.
30 µL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm2; as indicated by supplier).
DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8≤mean OD≤2.8. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).
After the treatment with the test item, the relative absorbance values were reduced to 3.3 %. This value is well below the threshold for irritation potential (50%).
Therefore, KCCS DOB11 is considered as “irritant in the Human Skin Model Test”.
In the UN GHS System for skin irritating substances, KCCS DOB11should be classified in UN GHS category 2.
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