Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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: Directive 96/54/CEE, Partie B, Méthode B.6. Ligne directrice No. 406, de l'OCDE EPA OPPTS 870.2600 EPA 712-C-98-197
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: Cobaye albinos, souche Dunkin/Hartley

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Injection intradermique : 5 % de p/v, dans de l'Alembicol D


Application topique : 17,5 % de p/v, dans de l'Alembicol D

Concentration of test material and vehicle used for each challenge:
35 et 17,5 % de p/v, dans de l'Alembicol D
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Injection intradermique : 5 % de p/v, dans de l'Alembicol D


Application topique : 17,5 % de p/v, dans de l'Alembicol D

Concentration of test material and vehicle used for each challenge:
35 et 17,5 % de p/v, dans de l'Alembicol D
No. of animals per dose:
Number of animals in test group: 10
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:
35 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
17.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 17.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
35 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
17.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 17.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
35 %
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: 35 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
17.5 %
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: 17.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
35 %
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: 35 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
17.5 %
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: 17.5 %. 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: 35 %

Signs of irritation during induction:
Injection intradermique : Chez les animaux testés et les
animaux témoins, on a observé une nécrose aux sites recevant
de l'adjuvant complet de Freund. Chez les animaux testés, on
a noté une légère irritation aux sites recevant de la
substance testée à raison de 5 % de p/v, dans de l'Alembicol
D. Les témoins ayant reçu de l'Alembicol D ont présenté une
légère irritation.


Application topique : Aucun érythème n'a été noté chez les
animaux testés, après une application topique de substance
testée, à raison de 17,5 % de p/v, dans de l'Alembicol D. Le
cobaye servant de témoin n'a présenté aucun érythème.

De ce fait un prétraitement au laurylsulfate de sodium a été
effectué.

Evidence of sensitisation of each challenge concentration:
0/10

Other observations:
Au cours de cette étude, aucune mort et aucun signe de
mauvaise santé, ni de toxicité, n'ont été observés.

Applicant's summary and conclusion

Interpretation of results:
other: not classified