Registration Dossier
Registration Dossier
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EC number: 479-480-2 | CAS number: 17852-52-7
Skin sensitisation
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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