Registration Dossier

Diss Factsheets

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: OCDE 406, 17 Juillet 1992 CE Directive 96/54/EEC, B6, 30 Juin 1996
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: Cochon d'Inde (Dunkin Hartley)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Test item : 0.1 % dans un mélange FCA /NaCl 50/50 v/v

FCA : Freund's complete adjuvant

Concentration of test material and vehicle used for each challenge:
25 % du test item p/p dans l'acétone
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Test item : 0.1 % dans un mélange FCA /NaCl 50/50 v/v

FCA : Freund's complete adjuvant

Concentration of test material and vehicle used for each challenge:
25 % du test item p/p dans l'acétone
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:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
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: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
3
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: 3.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
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: 24.0. 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:
25 %
No. with + reactions:
1
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: 1.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Signs of irritation during induction:
Dans l'essai préliminaire des effets correspondant à une
irritation légère sont notés lors de l'injection à 0,1% et
de l'application cutanée dans les conditions d'induction à
25 %

Evidence of sensitisation of each challenge concentration:
0/19

On note dans le groupe traité un érythème de degré 1 chez 3
animaux sur le site traité avec la substance à 25 % (48
heures) mais également un érythème de degré 1 chez 4 animaux
sur le flanc opposé traité par le solvant seul. Cet effet
est considéré comme non spécifique.

Other observations:
Une femelle du groupe traité est morte au cours de l'essai.

Applicant's summary and conclusion

Interpretation of results:
other: not classified