Registration Dossier
Registration Dossier
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EC number: 456-080-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.6 (Meerschweinchen-Maximierungstest (GPMT)); OECD 406
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: gpg, Hsd Win:DH (SPF)
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal: a) 5 % (w/v) in physiologischer
NaCl-Lsg.
b) 5 % (w/v) in Freunds Adjuvans mit
physiologischer NaCl-Lsg. 1:1
b) Epidermal: 50 % (w/v) in physiologischer NaCl-Lsg.
"ENGLISH"
a) Intradermal: a) 5 % (w/v) in physiological
NaCl solution
b) 5 % (w/v) in Freund's adjuvant with
physiological NaCl solution 1:1
b) Epidermal: 50 % (w/v) in physiological NaCl solution
Concentration of test material and vehicle used for each challenge:
Provokation: a) 25 %
b) 50 % (w/v) jeweils in physiologischer
NaCl-Lsg.
"ENGLISH"
Challenge: a) 25 %
b) 50 % (w/v) in each case in physiological
NaCl solution
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal: a) 5 % (w/v) in physiologischer
NaCl-Lsg.
b) 5 % (w/v) in Freunds Adjuvans mit
physiologischer NaCl-Lsg. 1:1
b) Epidermal: 50 % (w/v) in physiologischer NaCl-Lsg.
"ENGLISH"
a) Intradermal: a) 5 % (w/v) in physiological
NaCl solution
b) 5 % (w/v) in Freund's adjuvant with
physiological NaCl solution 1:1
b) Epidermal: 50 % (w/v) in physiological NaCl solution
Concentration of test material and vehicle used for each challenge:
Provokation: a) 25 %
b) 50 % (w/v) jeweils in physiologischer
NaCl-Lsg.
"ENGLISH"
Challenge: a) 25 %
b) 50 % (w/v) in each case in physiological
NaCl 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:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. 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:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction:
Keine; vor der zweiten Induktion wurde die Haut der Tiere
mit Natriumlaurylsulfat vorgereizt.
"ENGLISH"
None; the skin of the animals was pre-irritated with sodium
lauryl sulphate prior to the second induction.
Evidence of sensitisation of each challenge concentration:
Keine
"ENGLISH"
None
Other observations:
Nach der zweiten Induktion bildeten sich am 10. Tag an zwei
Tieren blutende Wunden, die aber nach Krustenbildung bis zum
15. Tag wieder abheilten.
"ENGLISH"
After the second induction bleeding wounds formed in two
animals on the 10th day. However, after scab formation they
healed again by the 15th day.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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