Registration Dossier
Registration Dossier
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EC number: 401-540-3 | CAS number: 84632-65-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 401-540-3
- EC Name:
- -
- Cas Number:
- 84632-65-5
- Molecular formula:
- C18H10Cl2N2O2
- IUPAC Name:
- 3,6-bis(4-chlorophenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: A01297 (Cinilex DPP RED SR1C)
- Expiration date of the lot/batch: -
- Purity test date: -
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room tempreature in the dark
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -25 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5%, 10% or 25% w/w in acetone/olive oil 4:1
- No. of animals per dose:
- 4
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.99
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Test group / Remarks:
- 10%
- Remarks on result:
- other: no results due to accidential spillage of pooled lymph node cell suspension
- Key result
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 25%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: vehicle: 7694.44 5%: 7593.42 25% 8718.31
Any other information on results incl. tables
Due to accidental spillage of the single cell suspension of pooled lymph node cells for the group treated with the test material at a concentration of 10%, the results obtained cannot be verified as being accurate. For this reason the results for the 10% group were not used for reporting purposes. This was considered not to affect the purpose or integrity of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a GLP-study according to OECD test guideline 429 (LLNA), the substance was not skin sensitising.
- Executive summary:
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Following a preliminary screening test, three groups, each of four animals, were treated with 50 p.1 (25 p1 per ear) of the test material as a suspension in acetone/olive oil 4:1 at concentrations of 5%, 10% or 25% w/w. A further group of four animals was treated with acetone/olive oil 4:1 alone.
Due to accidental spillage of the single cell suspension of pooled lymph node cells for the group treated with the test material at a concentration of 10%, the results obtained cannot be verified as being accurate. For this reason the results for the 10% group were not used for reporting purposes. This was considered not to affect the purpose or integrity of the study.
Simulation Indexes for 5% and 25 % were 0.99 and 1.13, respectively. Therefore, the test material was considered to be a non-sensitiser under the conditions of the test.
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