Registration Dossier
Registration Dossier
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EC number: 417-120-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC B.6
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: guinea pig (m), SPF-gezüchtet Hsd Win:DH
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) interdermal induction 5 % in Cremophor EL/normal saline
solution
b) topical induction 100 %
treated areals were stimulated with 10 % sodium lauryl
sulphate in vaseline
Concentration of test material and vehicle used for each challenge:
topical provocation a) 100 %
b) 50 % in Cremophor EL/normal saline
solution
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) interdermal induction 5 % in Cremophor EL/normal saline
solution
b) topical induction 100 %
treated areals were stimulated with 10 % sodium lauryl
sulphate in vaseline
Concentration of test material and vehicle used for each challenge:
topical provocation a) 100 %
b) 50 % in Cremophor EL/normal saline
solution
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Signs of irritation during induction:
none
Evidence of sensitisation of each challenge concentration:
see table
Other observations:
none
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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