Registration Dossier
Registration Dossier
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Reaction mass of 6-(2-ethyl-6-methylanilino)-5-(4-{4-[ethyl(3-sulfobenzyl) amino] phenylazo} phenylazo)-4-hydroxynaphthalene-2-sulfonic acid, sodium and/or disodium salt(s) and 6-(2-ethyl-6-methylanilino)-5-(4-{4-[ethyl(4-sulfobenzyl) amino] phenylazo} phenylazo)-4-hydroxynaphthalene-2-sulfonic acid, sodium and/or disodium salt(s)
EC number: 475-080-7 | 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Acid Navy RN-2682
- IUPAC Name:
- Acid Navy RN-2682
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- temperature: 22 ± 3 °C
relative humidity: 30 - 82 %
artificial light: 6 a.m. to 6 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10, 25 %
- No. of animals per dose:
- 4
- Details on study design:
- Application volume: 25 µl on the entire dorsal surface of each ear lobe once daily for 3 consecutive days.
5 days after the first topical application, all mice were administered with 250 µl of 78.8 µCi/ml 3HTdR by i.v. injections via a tail vein.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 5 %
- Parameter:
- SI
- Value:
- 1.35
- Test group / Remarks:
- 10 %
- Parameter:
- SI
- Value:
- 1.96
- Test group / Remarks:
- 25 %
- Cellular proliferation data / Observations:
- The EC3 value could not be calculated, since all SI´s are below 3.
Viability / mortality: no deaths occurred during the study period.
Clinical signs: no symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
Body weights: the body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not sensitising.
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