Registration Dossier
Registration Dossier
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EC number: 473-450-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 2006 - 17 May 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- No. 338 Red
- IUPAC Name:
- No. 338 Red
- Details on test material:
- Description: red powder
Batch number: 50670
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- Mice were treated with 10, 25 or 50% w/w in dimethyl sulphoxide.
- No. of animals per dose:
- 4 mice per dose
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Concentration Stimulation index (SI) Vehicle N/A 10% 3.18 25% 3.45 50% 4.46
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration DPM Vehicle 8928.22 10% 28395.65 25% 30802.11 50% 39841.29 Concentration Dpm/node vehicle 1116.03 10% 3549.46 25% 3850.26 50% 4980.16
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- In an LLNA study in mice, a stimulation index of greater than 3 was recorded for the three concentrations of the test material (10%, 25% and 50%).
No signs of systemic toxicity were observed in test or control animals during the study period. Very dark re-coloured staining of the fur was noted in test animals one hour post dosing throughout the study period. Based on the results of this study, the test substance is considered a skin sensitizer.
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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