Registration Dossier
Registration Dossier
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EC number: 459-990-1 | CAS number: 52411-34-4
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: 96/54/EWG, B.6 (Meerschweinchen-Maximierungstest (GPMT))
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: gpg, HsdPoc:DH
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal: 1 % in Tylose
b) Dermal: 25 % in Tylose
Concentration of test material and vehicle used for each challenge:
Dermal: 25 % in Tylose
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal: 1 % in Tylose
b) Dermal: 25 % in Tylose
Concentration of test material and vehicle used for each challenge:
Dermal: 25 % in Tylose
- 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:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- 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: 25 %. 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: 25 %
Signs of irritation during induction:
Die intradermalen Injektionen mit FCA (mit und ohne
Testsubstanz verursachten starke Erytheme und Ödeme, sowie
Verhärtungen und Verkrustungen. Die mit der Testsubstanz im
Vehikel verabreichten Injektionen führten zu leichten
Erythemen und Ödemen. Die Injektionen mit dem Vehikel allein
verursachten keine Reizeffekte.
Die mit FCA behandelten Hautstellen zeigten nach der
dermalen Behandlung klar ausgebildete Erytheme und Ödeme,
sowie Verhärtungen und Verkrustungen und sporadisch
Nekrosen. Die dermale Behandlung mit der Testsubstanz im
Vehikel führte zu leichten Erythemen. Die dermale
Verabreichung des Vehikels allein ergab keine Reizeffekte.
"ENGLISH"
intradermal injections with Freund's Adjuvant (with and
without test substance) caused severe erythema and oedema
as well as indurations and encrustations. The
administration sites treated with the test substance in
Tylose showed slight erythema and oedema. Intradermal
injections of the vehicle alone exhibited no signs of
irritation.
After dermal treatment, the parts of the skin treated with
FCA revealed clearly formed erythema and oedema as well as
indurations and incrustations and sporadic necroses. The
dermal treatment with the test substance in the vehicle
resulted in slight erythemas. The dermal administration of
the vehicle on its own did not produce any irritant effects.
Evidence of sensitisation of each challenge concentration:
Behandlungsgruppe: 0/10
Kontrollgruppe: 0/5
"ENGLISH"
Treatment group: 0/10
Control group: 0/5
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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