Registration Dossier
Registration Dossier
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EC number: 449-680-4 | 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 (Meerschweinchen-Maximierungstest (GPMT))
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: gpg, Hsd Poc:DH
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal: 5 % in Polyethylenglykol 400
b) Topisch: 25 % in Polyethylenglykol 400
"ENGLISH"
a) Intradermal: 5 % in polyethylene glycol 400
b) Topical: 25 % in polyethylene glycol 400
Concentration of test material and vehicle used for each challenge:
Auslösephase: 12 % in Polyethylenglykol 400
"ENGLISH"
Challenge phase: 12 % in polyethylene glycol 400
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal: 5 % in Polyethylenglykol 400
b) Topisch: 25 % in Polyethylenglykol 400
"ENGLISH"
a) Intradermal: 5 % in polyethylene glycol 400
b) Topical: 25 % in polyethylene glycol 400
Concentration of test material and vehicle used for each challenge:
Auslösephase: 12 % in Polyethylenglykol 400
"ENGLISH"
Challenge phase: 12 % in polyethylene glycol 400
- 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:
- 12 %
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12 %. No with. + reactions: 18.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12 %
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12 %. No with. + reactions: 16.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12 %
- 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: 12 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12 %
- 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: 12 %. 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: 0 %
Signs of irritation during induction:
Nach der intradermalen Induktion (1. Induktion) wurden bei
den Kontroll- und bei den Versuchstieren folgende
Beobachtungen gemacht:
- rote Schwellungen
- Verkrustungen
- weiße Schwellungen mit rotem Rand.
Nach 7 Tagen wurden keine Effekte mehr an der
Induktionsstelle der Kontrollgruppe beobachtet.
Bei den Versuchstieren wurden Schwellungen und Verkrustungen
beobachtet.
Ab dem 9. Tag, direkt nach Entfernung des Patches der 2.
Induktion, wurden an 19 Tieren der Versuchsgruppe Effekte
(Grad 1-2) beobachtet. Ab Tag 10 bis zum Abschluss der
Studie wurden Verkrustungen auf der behandelten Stelle der
2. Induktion bemerkt.
Bei der Kontrollgruppe traten keine Reaktionen auf.
"ENGLISH"
After the intradermal induction (1st induction), the
following observations were made in connection with the
control and test animals:
- red swellings
- incrustations
- white swellings with a red border.
After 7 days no effects on the induction site of the control
group were observable any longer.
Swellings and incrustations were observed in the test
animals.
Effects (grade 1-2) were observed in 19 animals from the
test group on the 9th day, directly after removal of the
patch for the 2nd induction. From day 10 up to the
conclusion of the study, incrustations were observable on
the treated site of the 2nd induction.
No reactions occurred in the control group.
Evidence of sensitisation of each challenge concentration:
Auslösung mit 12 %: 19/20; Reizgrad: 1 - 2
"ENGLISH"
Challenge with 12 %: 19/20; degree of irritation: 1 - 2
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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