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: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Acid Navy RN-2682
- IUPAC Name:
- Acid Navy RN-2682
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- Application volume: 6 ml/kg bw
24 h after application, the dressing was removed and the skin was flushed with lukewarm tap water.
The fur of animals was shaved on test days 3, 7, 10 just after the assessment of the reaction to facilitate the skin reading for the next day.
Observations: daily, during days 2 - 15
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality.
- Clinical signs:
- No systemic signs of toxicity were observed during the study period.
- Body weight:
- One animal did not gain weight from test day 1 up to test day 8. Otherwise, the body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Other findings:
- A slight to marked erythema was noted in all animals from
test day 2 up to test day 4, 5 or 6. A violet staining of
the skin was recorded in all animals from test day 2 up to test day 3 or 4. Four animals showed slight crusts; one
animal at test day 3, two animals from test day 6 up to test
day 9 or 10 and the remaining animal from test day 3 up to test day 8. A slight skin exfoliation was noted in all
females at test day 3 which persisted in trhee animals up to
test day 9 and in one animal up to test day 10.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
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