Registration Dossier
Registration Dossier
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EC number: 609-124-5 | CAS number: 3541-81-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Only two animals were used in the epidermal pretest.
- Principles of method if other than guideline:
- -
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- test was done before the legislation entered into force
Test material
- Reference substance name:
- Phosphonium, (3-methyl-4-oxo-2-butenyl)triphenyl-, chloride
- EC Number:
- 609-124-5
- Cas Number:
- 3541-81-9
- Molecular formula:
- C23 H22 O P . Cl
- IUPAC Name:
- Phosphonium, (3-methyl-4-oxo-2-butenyl)triphenyl-, chloride
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 1% in water, 20% in PEG-400
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 1% in water, 20% in PEG-400
- No. of animals per dose:
- 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- erythema and oedema reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- erythma reactions, no oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythma reactions, no oedema.
Any other information on results incl. tables
-
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- substance is sensitizing
- Executive summary:
Wittigaldehydechlorid was administered intradermally at a concentration of 1% in H20 and epicutaneous under occlusion at 20% in PEG-400 for induction. The challenge and rechallenge tests were performed with 20% Wittigaldehydechlorid in PEG-400.
These experimental data indicate that Wittiagaldehydechloride possesses allergenic potential for guinea pigs. Contamination of human skin surface by this chemical may cause skin allergy. During handling protective health measures, i.e. wearing of gloves
and respirator, therefore are obligatory.
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