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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

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: 92/69/EWG, B.6; OECD 406
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Pirbright-White, Hoe: DHPK (SPFLac)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 5 % in isotonischer NaCl-Lösung

b) dermal: 100 %

Concentration of test material and vehicle used for each challenge:
dermal: 100 %
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 5 % in isotonischer NaCl-Lösung

b) dermal: 100 %

Concentration of test material and vehicle used for each challenge:
dermal: 100 %
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Signs of irritation during induction:
Die intradermalen Injektionen mit Freund's Adjuvans (mit und
ohne Testsubstanz) führten zu mäßigen Erythemen und Ödemen
und teilweise zu verkrusteter und verhärteter Haut. Wegen
der starken Reizeffekte wurden die Tiere am 7. Tag nicht mit
Natriumdodecylsulfat (10 %) behandelt.



"ENGLISH"

The intradermal induction with Freunds adjuvans (with and
without test substance) led to moderate erythems and oedema
adn partial crusted and hardened skin. Due to the strong
irritational effect the animals were not treated with sodium
dodecyl sulfate (10%) on day 7.

Evidence of sensitisation of each challenge concentration:
Behandlungsgruppe: 0/10 (test group: 0/10)

Kontrollgruppe:    0/5  (controls:  0/10)

Applicant's summary and conclusion

Interpretation of results:
other: not classified