Registration Dossier
Registration Dossier
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EC number: 912-664-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD Guideline 406 and EU Method B.6 The test material has no batch number and no information on purity nor particle size distribution.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The conduct of this study was prior to the establishment of the LLNA method (OECD 429).
Test material
- Reference substance name:
- Coated copper flakes
- IUPAC Name:
- Coated copper flakes
- Details on test material:
Lot/Batch number: not provided
Specification: no information was provided on the specification of the sample used in this study.
Purity: not provided
Stability: active substance: not provided. Dosing preparations: no stability analysis was conducted; however dosing preparations were freshly prepared
Preparation of test substance for application: for both induction and challenge the test material was freshly prepared in arachis oil BP
Pretest performed on irritant effects: yes
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Source: sighting animals were received from David Hall Limited, Burton-on-trent, Staffordshire, UK. Main study animals were received from Harlan UK Ltd., Blackthorn, Bicester, Oxon, UK.
At the start of the main study the animals weighed 340 to 436g and were approximately eight to twelve weeks old.
6 sighting animals, 10 test animals and 5 control animals
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 0.1 % w/w in arachis oil BP.
Topical induction: 50% w/w in arachis oil BP
Topical challenge: 50 and 25% w/w in arachis oil BP
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 0.1 % w/w in arachis oil BP.
Topical induction: 50% w/w in arachis oil BP
Topical challenge: 50 and 25% w/w in arachis oil BP
- No. of animals per dose:
- 10
- Details on study design:
- Day 0: intradermal induction
Day 7: topical induction
Day 21: topical challenge
scoring: 24 and 48h after challenge - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- other: Non-concurrent positive control studies with 2 -mercaptobenzothiazole, showing 90 -100 % incidence of sensitisation, confirmed the sensitivity of this assay
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reactions were noted at the challenge sites of the control group animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 % w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no skin reactions were noted at the challenge sites of the control group animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reactions were noted at the challenge sites of the control group animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no skin reactions were noted at the challenge sites of the control group animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions were noted at the challenge sites of the test group animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reactions were noted at the challenge sites of the test group animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions were noted at the challenge sites of the test group animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reactions were noted at the challenge sites of the test group animals.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material corresponds to the composition of “coated copper flakes” . Under the conditions of this test, copper powder produced a 0% (0/10) sensitisation rate. The test material did not meet the criteria for classification as a sensitiser by skin contact according to labelling regulations outlined in Annex VI of Commission Directive 2001/59/EC
- Executive summary:
The test material identity was not provided in details. Considering the information from the reports on the same material, the tested material falls in the composition category of "coated copper flakes", consistent with a biocidal product use (PBD notification was the reason for doing the test).
Under the conditions of this test, the test material produced a 0% (0/10) sensitisation rate.
Copper powder did not meet the criteria for classification as a sensitiser by skin contact according to labelling regulations outlined in Annex VI of Commission Directive 2001/59/EC
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