Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Type of information:
experimental study
Adequacy of study:
key study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: CEE - B6
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 5-[4-chloro-6-(N-ethyl-anilino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(1,5-disulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate
EC Number:
411-540-5
EC Name:
Tetrasodium 5-[4-chloro-6-(N-ethyl-anilino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(1,5-disulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate
Cas Number:
130201-57-9
Molecular formula:
C31H20ClN7Na4O13S4
IUPAC Name:
tetrasodium 5-[4-chloro-6-(N-ethyl-anilino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(1,5-disulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate

In vivo test system

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Induction intradermique : 5% dans l'eau bidistillee
b) Induction epidermique : 25% dans l'huile de vaseline

Concentration of test material and vehicle used for each challenge :
a) Apres deux semaines : 25% dans l'huile de vaseline
b) Apres quatre semaines : 25 et 10% dans l'huile de vaseline

Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Induction intradermique : 5% dans l'eau bidistillee
b) Induction epidermique : 25% dans l'huile de vaseline

Concentration of test material and vehicle used for each challenge :
a) Apres deux semaines : 25% dans l'huile de vaseline
b) Apres quatre semaines : 25 et 10% dans l'huile de vaseline

No. of animals per dose:
Number of animals in test qroup : 20
Number 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:
9
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: 9.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
7
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: 7.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 7.0. 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:
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.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in prelim.

Evidence of sensitisation of each challenge concentration : 9 à 25% au premier déclenchement

Applicant's summary and conclusion

Interpretation of results:
other: irritant