Registration Dossier
Registration Dossier
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EC number: 415-430-8 | CAS number: 86403-32-9 CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
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)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 406 (1992); (Meerschweinchen-Maximierungstest (GPMT))
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Dastib 845
- IUPAC Name:
- Dastib 845
Constituent 1
In vivo test system
Test animals
- Species:
- other: gpg, Pirbrigth White Bor:DHPW (SPF)
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermalen Induktion:
0.1 ml FCA (w/v) in aqua ad iniect.
0.1 ml Prufsubstanz in Maisol (Endkonzentration = 2.5 %)
0.1 ml Prufsubstanz in FCA/aqua (Endkonzentration = 2.5 %)
Aktuelle Induktion:
50 % in Maisol
Concentration of test material and vehicle used for each challenge:
25 %
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermalen Induktion:
0.1 ml FCA (w/v) in aqua ad iniect.
0.1 ml Prufsubstanz in Maisol (Endkonzentration = 2.5 %)
0.1 ml Prufsubstanz in FCA/aqua (Endkonzentration = 2.5 %)
Aktuelle Induktion:
50 % in Maisol
Concentration of test material and vehicle used for each challenge:
25 %
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- 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: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 17
- 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: 17.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction:
Eine Endkonzentration von 5 % verursachte Schwellung und
Rotungen in einem Rangessfinding Test. Eine geeignete
Konzentration fur die Hauptuntersuchung war 2.5 %.
Evidence of sensitisation of each challenge concentration:
Nach Auslosung (t-24 nach Entfernung des Pflasters) zeigten
alle Versuchstiere (10/Geschlecht) eine allergische
Reaktion, sei es durch Odeme und/oder Hautrotungen. 48
Stunden nach Entfernung des Pflasters reagierten 8 mannliche
und 9 weibliche Tiere.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
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