Registration Dossier
Registration Dossier
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EC number: 236-783-2 | CAS number: 13479-54-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- other: short communication
- Title:
- Sensitizing potential of beryllium, copper and molybdenum compounds studied by the guinea pig maximization method
- Author:
- A. Boman, J.E. Wahlberg, G Hagelthorn
- Year:
- 1 979
- Bibliographic source:
- Contact Dermatitis 1979 Vol. 5; Iss. 5
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
Test according to the principle of Magnusson & Kligman 1970.
- Short description of test conditions: Two groups of 20 animals were used for each metal compound. One group was actively sensitiactl and the other group (control was treated in the same way as the experimental group (Freund's complete adjuvant, petrolatum occlusion. etc.) except for the test compound. The groups were kept separately in plastic cages. challenged simultaneously and the readings performed blind.
- Parameters analysed / observed: Number of positive animals (as scored according to Magnusson & Kligman (1970)) for each concentration is given. - GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Copper sulphate
- EC Number:
- 231-847-6
- EC Name:
- Copper sulphate
- Cas Number:
- 7758-98-7
- Molecular formula:
- Cu.H2O4S
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Animals were kept in plastic cages, size was not reported. No further details on test animals and environmental conditions were given.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.01%
- Adequacy of induction:
- other: no information on concentration finding test, duration was also not reported
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25%
- Adequacy of induction:
- other: no information on concentration finding tests, duration was not reported
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1.0, 0.5, 0.1%
- Adequacy of challenge:
- other: no information on concentration finding tests, duration was not reported
- No. of animals per dose:
- 10
- Details on study design:
- No further details on study design reported
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% challenge concentration
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% challenge concentration
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test described in the abstract of Boman et al., 1979, was conducted according to Magnusson & Kligman (1970). Groups of 10 guinea pigs were treated intradermally and epicutaneously with 0.01% and 25%, respectively. 21 days after the intradermal application the animals were challenged with 1.0, 0.5, and 0.1% copper sulphate solution in petrolatum. After 24 h (first reading 2 animals were scored positive for sensitisation and after 48h 7 animals were scored positive for skin sensitisation, thus, copper sulphate was regarded positive with respect to skin sensitisation.
- Executive summary:
The test described in the abstract of Boman et al., 1979, was conducted according to Magnusson & Kligman (1970). Groups of 10 guinea pigs were treated intradermally and epicutaneously with 0.01% and 25%, respectively. 21 days after the intradermal application the animals were challenged with 1.0, 0.5, and 0.1% copper sulphate solution in petrolatum. After 24 h (first reading) 2 animals were scored positive for sensitisation and after 48h 7 animals were scored positive for skin sensitisation, thus, copper sulphate was regarded positive with respect to skin sensitisation.
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