Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted at GLP-accredited facility to current guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, 100%
- No. of animals per dose:
- 5
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- concentration 25%
- Value:
- 8.4
- Test group / Remarks:
- 5 animals
- Key result
- Parameter:
- SI
- Remarks:
- concentration 50%
- Value:
- 15.3
- Test group / Remarks:
- 5 animals
- Key result
- Parameter:
- SI
- Remarks:
- concentration 100%
- Value:
- 22.3
- Test group / Remarks:
- 5 animals
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The EC3 value (derived by linear interpolation) could not be calculated as teh stimulation indices of all conecntrations were above 3.
Acc. to Commission regulation (EU) No 286/2011 as well as GHS the test item DVSA1 has obligatory labelling requiremnet for skin and is classified into Category 1. - Executive summary:
There was no mortality and there were clinical observations but no effects on body weights.
All of the three tested concentrations exceeded the stimulation index of 3.
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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