Registration Dossier
Registration Dossier
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EC number: 700-453-0 | CAS number: 59802-05-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- other: EPISKIN Skin Irritation Test-42 hours
- Adequacy of study:
- key study
- Study period:
- 22.11.2010 to 14.02.2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- EC Number:
- 700-453-0
- Cas Number:
- 59802-05-0
- Molecular formula:
- C26H42O4
- IUPAC Name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- distilled water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Skin Irritation Test-42 hours
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 37 ± 2°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1 x 25 ml of sterile Dulbeccos Phosphate
Buffered Saline (DPBS)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2 ml of 0.3 mg/ml MTT
- Incubation time: 3 hours ± 5 minutes
- Wavelength: 540 nm
NUMBER OF REPLICATE TISSUES: triplicates
PREDICTION MODEL / DECISION CRITERIA
If the mean tissue viability was equal to or less than 50% of the negative control value, the
sample was classed as Irritant R38 (EU classification) or Category 2 (GHS classification). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 μl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µl
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µl
- Concentration (if solution): 5 % - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- >= 98.6 - <= 118
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The results of the assay are summarised in the table below.
| Sample | Tissue viability as percentage of mean OD negative control |
Prediction | |||
| Mean ± SD | |||||
| a | b | c | |||
| Negative Control | 100.7 | 101.7 | 97.7 | 100.0±2.1 |
Not applicable |
| Positive Control | 13.1 | 49.6 | 13.8 | 25.5±20.9 |
Irritant |
Bis(C9(branched)alkyl) benzene-1,4-dicarboxylate |
118.0 | 98.6 | 113.2 | 109.9±10.1 |
Non-irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that the test substance, Bis(C9(Branched)Alkyl)Benzene-1,4-Dicarboxylate,
with a mean tissue viability of 109.9 ± 10.1%, was predicted as non-irritant to the skin.
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