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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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