Registration Dossier
Registration Dossier
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EC number: 405-400-2 | CAS number: 54253-62-2 KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study conducted by GLP accredited lab according to recognised guideline method. Data provided by ECHA from migrated NONS file. Litle detail available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- not specified
Test material
- Reference substance name:
- Copper(II) methanesulfonate
- EC Number:
- 405-400-2
- EC Name:
- Copper(II) methanesulfonate
- Cas Number:
- 54253-62-2
- Molecular formula:
- C2H6CuO6S2
- IUPAC Name:
- copper(2+) dimethanesulfonate
- Test material form:
- solid - liquid: suspension
- Remarks:
- migrated information: dispersion
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- stage a) 0.01% (w/v) in distilled water (intradermal) and 75% w/w (dermal)
stage b) 0.01% (w/v) in Freud's complete Adjuvans plus distilled water 1:1 (intradermal)
Challengeopen allclose all
- Route:
- other: dermal
- Vehicle:
- water
- Concentration / amount:
- stage a) 0.01% (w/v) in distilled water (intradermal) and 75% w/w (dermal)
stage b) 0.01% (w/v) in Freud's complete Adjuvans plus distilled water 1:1 (intradermal)
- No. of animals per dose:
- 20
- Challenge controls:
- concentration of test material and vehicle used at each challenge:
a) 1. dermal: 50% (w/w) in distilled water
2. dermal: 10% (w/w) in distilled water
b) -
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- see remarks
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: see remarks.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- see remarks
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: see remarks.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: positive control. No with. + reactions: 1.0. Total no. in groups: 10.0.
Any other information on results incl. tables
All treatment sites were blue-coloured stained by the test material.
very slight or well defined erytema and incidents of oedema were noted an hour after removal of the patch.
very slight erythem persisted at two skin sites at the 24h observation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- the substance is not classified as a skin sensitiser
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