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Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- tris (4-nonylphenol, branch) phosphorous acid ester
- Cas Number:
- 26523-78-4
- Molecular formula:
- C45H69O3P
- IUPAC Name:
- tris (4-nonylphenol, branch) phosphorous acid ester
- Reference substance name:
- Nonylphenol
- EC Number:
- 246-672-0
- EC Name:
- Nonylphenol
- Cas Number:
- 25154-52-3
- IUPAC Name:
- 2-nonylphenol
- Test material form:
- liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25, 50, 100%
- No. of animals per dose:
- 3
- Details on study design:
- After an acclimation period of 5 days, animals were randomly selected into cages and assigned a number. All animals were nulliparous and not pregnant. The mice were 8-12 weeks old at the start of the study. Based on a preliminary screening study that found no systemic toxicity or excessive loirritation, doses were set at 25%, 50%, and 100% concentrations. A control group was run in the vehicle only.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 25% - 1.5250% - 2.47100% - 0.87
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0% (Vehicle) - 2254.5925% - 3435.0350% - 5559.62100% - 1970.86
Any other information on results incl. tables
Conc |
dpm/ node |
Test / Control Ratio |
Result |
Blank |
2254.59 |
N/A |
N/A |
25% |
3435.03 |
1.52 |
Negative |
50% |
5559.62 |
2.47 |
Negative |
100% |
1970.86 |
0.87 |
Negative |
EC3 value = Not established (all concentrations negative). |
|||
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- TNPP was not sensitising at all concentrations (25, 50 and 100%).
- Executive summary:
This study indicates that TNPP is not a skin sensitiser.
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