Registration Dossier
Registration Dossier
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EC number: 612-396-8 | CAS number: 61791-19-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study, acoording to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Frey-Tox GmbH, Osteroda 38, Herzberg/Elster
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated
- EC Number:
- 612-396-8
- Cas Number:
- 61791-19-3
- Molecular formula:
- C2 H7 N O . C2 H4 O . Unspecified
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Induction: 75 % (w/w)
Challenge: 25 % (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Induction: 75 % (w/w)
Challenge: 25 % (w/w)
- No. of animals per dose:
- treated group: 20 animals
negative control group: 10 animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % of test item in PEG
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % of test item in PEG. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % of test item in PEG
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % of test item in PEG. No with. + reactions: 11.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 % of test item in PEG
- 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: 25 % of test item in PEG. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % of test item in PEG
- 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: 25 % of test item in PEG. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
As 11/20 (55 % ) animals of the test group showed skin reactions after 48 h reading, no re-challenge was conducted.
No skin reactions were observed in the control group and after challenge with the vehicle alone.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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