Registration Dossier
Registration Dossier
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EC number: 288-422-3 | CAS number: 85721-12-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Full article with few details on results
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
Constituent 1
- Specific details on test material used for the study:
- The test material was supplied by Tokyo Kasei Kogyo Industry Ltd, Tokyo Japan.
Test animals
- Species:
- other: mice
- Strain:
- other: ddY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 4 Male ddY mice were obtained from Japan SLC Co., Shizuoka, Japan, at 7 weeks of age and used after 1 week of acclimatization.
They were fed commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan) and tap water ad libitum throughout the acclimatization period and the experiment.
The animal room was at 20–24 ◦C with a 12 h light–dark cycle.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: saline solution
- Details on oral exposure:
- The test substance were dissolved in saline solution.
- Doses:
- All food additives were administered orally at up to 0.5 × LD50 or the limit dose of 2000 mg/kg.
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
Results and discussion
- Preliminary study:
- -
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- No data
- Body weight:
- No data
- Gross pathology:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Based on the test results, no toxic effect were seen for an oral application of the tested substance.
No death occurred during the fixed dose test.
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