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: 92/69/EWG, B.6 (Meerschweinchen-Maximierungstest (GPMT)); OECD 406
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Dunkin-Hartley Crl:(HA)BR

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermale Injektionen:

Substanz bei der Konzentration von 1 % (g/g) in

0,9 % NaCl.

b) Epidermale Applikation:

Substanz bei der Konzentration von 10 % (g/g) in

0,9 % NaCl.

"ENGLISH"

a) Intradermal injections:

Substance at the concentration of 1 % (g/g) in

0.9 % NaCl.

b) Epidermal application:

Substance at the concentration of 10 % (g/g) in

0.9 % NaCl.

Concentration of test material and vehicle used for each challenge:
Epidermale Applikation: Substanz bei der Konzentration von
10 % (g/g) in 0,9 % NaCl.

"ENGLISH"

Epidermal application: substance at the concentration of

10 % (g/g) in 0.9 % NaCl.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermale Injektionen:

Substanz bei der Konzentration von 1 % (g/g) in

0,9 % NaCl.

b) Epidermale Applikation:

Substanz bei der Konzentration von 10 % (g/g) in

0,9 % NaCl.

"ENGLISH"

a) Intradermal injections:

Substance at the concentration of 1 % (g/g) in

0.9 % NaCl.

b) Epidermal application:

Substance at the concentration of 10 % (g/g) in

0.9 % NaCl.

Concentration of test material and vehicle used for each challenge:
Epidermale Applikation: Substanz bei der Konzentration von
10 % (g/g) in 0,9 % NaCl.

"ENGLISH"

Epidermal application: substance at the concentration of

10 % (g/g) in 0.9 % NaCl.
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:
10 %
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 15.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 19.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 3.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %

Signs of irritation during induction:
Mit intradermaler Injektion am Tag 1 (Konzentration

gewählt nach den Ergebnissen von den Vorversuchen).

Mit epidermaler Applikation der Substanz am Tag 8 (während
48 Stunden).

"ENGLISH"

With intradermal injection on day 1 (concentration selected
according to the results of the pretests).

With epidermal application of the substance on day 8 (during
48 hours).

Evidence of sensitisation of each challenge concentration:
Die Substanz verursacht verzögerte
Kontaktüberempfindlichkeit in 15/20 (75 %) der Tiere.

"ENGLISH"

The substance causes delayed contact hypersensitivity in
15/20 (75 %) of the animals.

Other observations:
Wegen der Substanz, wurde eine gelbliche Verfärbung der
behandelten Körperstelle in allen Tieren beider Gruppen
beobachtet. Es könnte einen möglichen getrennten oder
gemäßigten Erythema (Grad 1 oder 2) in einigen von den
Tieren am 24-stündigen Messwert verdeckt haben.

Eine Trockenheit der Haut wurde in 3/10 der Tiere der
Kontrollgruppe am 48-stündigen Messwert beobachtet.

Manchmal ist die Trockenheit der Haut mit Krusten und/oder
Ödemen verbunden. Die Trockenheit der Haut wurde in 16/20
der Tiere der behandelten Gruppe am 48-stündigen Messwert
beobachtet.



"ENGLISH"

Due to the substance, a yellowish discoloration of the
treated area of the body was observed in all of the animals
from both of the groups. It could have hidden a possible
separate or moderate erythema (grade 1 or 2) in some of the
animals at the 24-h measurement value.

Dryness of the skin was observed in 3/10 of the animals from
the control group at the 48-h measurement value. The dryness
of the skin is sometimes associated with scabs and/or
oedemas. The dryness of the skin was observed in 16/20 of
the animals from the treated group at the 48-h measurement
value.

Applicant's summary and conclusion

Interpretation of results:
other: irritant

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