Registration Dossier
Registration Dossier
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EC number: 424-450-6 | CAS number: 152628-03-0
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, Himalayan (SPF)
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermale Induktion: Testsubstanz in 2 %-iger
Konzentration
b) Epidermale Induktion: Testsubstanz in 50 %-iger
Konzentration (0,5 ml)
Da im Vorversuch keine Anzeichen einer Hautreizung
beobachtet wurden, wurde die Haut vor der epidermalen
Induktion mit einer 10 %igen Zubereitung aus Na-Laurylsulfat
(SDS) in Vaseline vorgereizt.
Vehikel: corn oil
"ENGLISH"
a) Intradermal induction: Test substance in 2%
concentration
b) Epidermal induction: Test substance in 50%
concentration (0.5 ml).
Since no signs of skin irritation were observed in the
pretest, the skin was pretreated with a 10% preparation of
sodium lauryl sulphate (SDS) in vaseline prior to the
epidermal induction.
Concentration of test material and vehicle used for each challenge:
a) Auslösephase: Testsubstanz in 50 %-iger Konzentration
Vehikel : corn oil
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermale Induktion: Testsubstanz in 2 %-iger
Konzentration
b) Epidermale Induktion: Testsubstanz in 50 %-iger
Konzentration (0,5 ml)
Da im Vorversuch keine Anzeichen einer Hautreizung
beobachtet wurden, wurde die Haut vor der epidermalen
Induktion mit einer 10 %igen Zubereitung aus Na-Laurylsulfat
(SDS) in Vaseline vorgereizt.
Vehikel: corn oil
"ENGLISH"
a) Intradermal induction: Test substance in 2%
concentration
b) Epidermal induction: Test substance in 50%
concentration (0.5 ml).
Since no signs of skin irritation were observed in the
pretest, the skin was pretreated with a 10% preparation of
sodium lauryl sulphate (SDS) in vaseline prior to the
epidermal induction.
Concentration of test material and vehicle used for each challenge:
a) Auslösephase: Testsubstanz in 50 %-iger Konzentration
Vehikel : corn oil
- 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:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction:
Sowohl bei der intradermalen als auch bei der epidermalen
Applikation wurden bei einigen Tieren der Prüf- und
Kontrollgruppe schwache Erytheme beobachtet, die auf die
Behandlung mit SDS zurückgeführt werden.
"ENGLISH"
Weakly developed erythemas, which were attributed to
treatment with SDS, were observed among some animals
from the test and the control groups in the case of both
intradermal and epidermal application.
Evidence of sensitisation of each challenge concentration:
Keine
"ENGLISH"
None
Other observations:
Es wurden keine Todesfälle und keine Anzeichen von
systemischer Toxizität beobachtet.
Im Verlauf der Studie war die Körpergewichtszunahme in der
Kontroll- und in der Prüfgruppe im selben Bereich.
"ENGLISH"
No mortalities and no signs of systemic toxicity were
observed.
In the course of the study, the body-weight gain in the
control and in the test groups was located within the same
range.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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