Registration Dossier
Registration Dossier
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EC number: 237-158-7 | CAS number: 13674-84-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication/study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Nothing to add in this field.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Tris(2-chloro-1-methylethyl) phosphate
- EC Number:
- 237-158-7
- EC Name:
- Tris(2-chloro-1-methylethyl) phosphate
- Cas Number:
- 13674-84-5
- Molecular formula:
- C9H18Cl3O4P
- IUPAC Name:
- tris(2-chloro-1-methylethyl) phosphate
- Details on test material:
- TCPP
There are differences in the isomer content from each supplier,but these are not important given that the properties of the isomers are expected to be very similar.
Purity
A typical purity(total of the four isomers)is>97.9%.All testing described in this report is for the commercial product.
Impurities
The impurity profile of the commercial product TCPP is specific to individual manufacturers. It is not likely that the impurities will have had particular influence on any of the results obtained.
Additives
No additives are used.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone:olive oil 4:1
- Concentration / amount:
- undiluted TCPP, concentrations of 50% or 25% v/v in acetone:olive oil 4:1 and 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone:olive oil 4:1
- Concentration / amount:
- undiluted TCPP, concentrations of 50% or 25% v/v in acetone:olive oil 4:1 and 100%
- No. of animals per dose:
- No data.
- Details on study design:
- Nothing to add in this field.
- Challenge controls:
- Nothing to add in this field.
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0%, 25%, 50% and 100%
- No. of animals per dose:
- 4 per dose.
- Details on study design:
- no data
- Positive control substance(s):
- not specified
- Statistics:
- no data
Results and discussion
- Positive control results:
- No positive control group in this study, so there is noting should add to this field.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 25%:1.55, 50%: 1.97, 100%:1.56
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 2.0
Any other information on results incl. tables
Nothing should add to this field.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to this study the substance is not sensitising to skin.
- Executive summary:
There were no mortalities or clinical observations and all bodyweights were comparable to those of the control animals.
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