Registration Dossier
Registration Dossier
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EC number: 701-028-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Testing conducted prior to REACH regulations.
Test material
- Reference substance name:
- 4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
- EC Number:
- 701-028-2
- Cas Number:
- 26523-78-4
- Molecular formula:
- C45H69O3P
- IUPAC Name:
- 4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
- 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:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Induction phase : 0.4 ml
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Induction phase : 0.4 ml
- No. of animals per dose:
- 38
- Details on study design:
- MAIN STUDY1st application: Induction undiluted occlusive epicutaneous 2nd application: Challenge undiluted occlusive epicutaneous Induction phase : 0.4 ml of the test substance, undiluted, was applied once per week for 3 consecutive weeks (Day 0,7 and 14) on one side of the animal, directly to the skin and covered with a gauze pad of approximately 4-6 cm2. The positive control substance, dinitrochlorobenzene (DNCB), was applied in the same manner. Naive animals (i.e. untreated during the induction phase) served as a negative control. CHALLENGE EXPOSUREThe skin was exposed to the test substance for 6 hours in the same way as for the induction phase. At approximately 21 hours after removal of the challenge dose, the area of the challenge was marked and the whole back shaved. Approximately 3 hours after shaving, the test site was examined for erythema and edema. Reading of the skin area was repeated at approximately 48 hours after removal of the challenge dose and the skin reactions were graded.
- Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene (DNCB)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 mL undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- All scores were 0
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 mL undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
-
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The results of the study were negative for skin sensitisation.
- Executive summary:
TNPP (neat; 100% concentration) was negative for skin sensitisation in this Buehler assay.
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