Registration Dossier
Registration Dossier
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EC number: 606-738-5 | CAS number: 213265-81-7
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 study according EU/OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 4-chloro-6-(2-chlorophenoxy)-5-fluoropyrimidine
- Cas Number:
- 213265-81-7
- Molecular formula:
- C10H5Cl2FN2O
- IUPAC Name:
- 4-chloro-6-(2-chlorophenoxy)-5-fluoropyrimidine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5% (= 20 mg test item/animal)
Topical induction: 100% (= 500 mg test item/animal)
Challenge: 25% (= 125 mg test item/animal)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5% (= 20 mg test item/animal)
Topical induction: 100% (= 500 mg test item/animal)
Challenge: 25% (= 125 mg test item/animal)
- No. of animals per dose:
- test group: 20
control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 %. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
The challenge with the 25% test item formulation led to skin effects (grade 1-3) in 20 of 20 animals (100%) in the test item group and no skin effects were seen in the control group animals. In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits a skin-sensitization potential.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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