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Toxicological information

Skin sensitisation

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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:
1993
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

Constituent 1
Reference substance name:
Dastib 845
IUPAC Name:
Dastib 845

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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