Registration Dossier
Registration Dossier
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EC number: 460-270-4 | CAS number: -
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/EG, B.6 (Magnusson-Kligman-Test)
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: gpg, Dunkin-Hartley
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 20 % in Sesamöl
b) dermal: 100 %
"ENGLISH"
intradermal: 20 % in sesame oil
dermal: 100 %
Concentration of test material and vehicle used for each challenge:
dermal: 50 % in Sesamöl
"ENGLISH"
dermal: 50% in sesame oil
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 20 % in Sesamöl
b) dermal: 100 %
"ENGLISH"
intradermal: 20 % in sesame oil
dermal: 100 %
Concentration of test material and vehicle used for each challenge:
dermal: 50 % in Sesamöl
"ENGLISH"
dermal: 50% in sesame oil
- 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:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- 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: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- 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: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- 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: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- 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: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation during induction:
Nach den intradermalen Injektionen mit FCA wurden klar
ausgebildete Erytheme festgestellt. Entsprechende
Injektionen mit FCA und Testsubstanz führte zu starken
Erythemen und starker Schorfbildung. Nur mit Testsubstanz
behandelte Injektionsstellen führten zu keinen Reaktionen
oder zu sehr leichten Erythemen. Die ausschließliche
Injektion des Vehikels ergab keine Reizerscheinungen.
Die dermale Applikation mit der unverdünnten Testsubstanz
führte zu mässigen bis deutlichen Erythemen und
Schwellungen. Daneben trat Abschuppung, Verhärtung und grüne
Verfärbung der Behandlungsstellen auf. Leichte Erytheme
wurden bei den mit dem Vehikel allein behandelten Tieren
festgestellt. Daneben trat bei diesen Tieren ebenfalls
Abschuppung, Verhärtung und grüne Verfärbung der
Behandlungsstellen auf.
"ENGLISH"
Clearly defined erythemas were determined after intradermal
injections with FCA. Corresponding injections with FCA and
the test substance resulted in severe erythemas and the
severe formation of eschar. Only injection sites treated
with the test substance did not result in any reactions or
only in very slight erythemas. The exclusive injection
of the vehicle did not result in any signs of irritation.
The dermal application involving the undiluted test
substance resulted in moderate to clear erythemas and
swellings. Desquamation, induration and green discoloration
of the treatment sites additionally occurred. Slight
erythemas were determined in the animals treated with the
vehicle alone. Desquamation, induration and green
discoloration of the treatment sites additionally also
occurred in these animals.
Evidence of sensitisation of each challenge concentration:
Behandlungsgruppe: 0/20
Kontrollgruppe: 0/10
"ENGLISH"
Treatment group: 0/20
Control group: 0/20
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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