Registration Dossier
Registration Dossier
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EC number: 229-208-1 | CAS number: 6428-31-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate
- EC Number:
- 229-208-1
- EC Name:
- Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate
- Cas Number:
- 6428-31-5
- Molecular formula:
- C34H29N13O7S2.2Na
- IUPAC Name:
- disodium 4-amino-3,6-bis({4-[(2,4-diaminophenyl)diazenyl]phenyl}diazenyl)-5-hydroxynaphthalene-2,7-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Charles River Wiga Gmbh Deutschland, Sulzfeld
- Weight at study initiation: The weights of the male rats are: 461,2 g ± 23,3 g. The weights of the female rats are: 275,2 g ± 11 g.
- Fasting period before study: 22 h
- Housing: 3 animals per cage Type 3 Makrolon
- Diet: Altromin 1326 ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20,5 - 22,5
- Humidity (%): 25-40
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- 600
- Doses:
- Single dose: 2000 mg/kg
- No. of animals per sex per dose:
- 6 male and 6 female
- Control animals:
- yes
- Statistics:
- Not applicable.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality
- Clinical signs:
- other: Diarrhoea occurred in 3 male rats 5 hours after exposure to the test substance. Discoloration of the faeces occurred 5 day after the exposure.
- Gross pathology:
- No damage to any organs.
- Other findings:
- The exposure to the tested substance did not influencing the behaviour of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The tested item was found to be non toxic for oral exposure with a LD50 > 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity was assessed following the OECD 401.
The results show no toxicity with a LD value > 2000 mg/kg.
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