Registration Dossier
Registration Dossier
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EC number: 305-897-5 | CAS number: 95193-83-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 2003
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2003
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 474 (In vivo mammalian erythrocyte micronucleus test)
- Version / remarks:
- July 1997
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- other: In the preliminary experiment mice were treated with 2000 mg/kg of the test item and observed for 48 hours.
- Limit test:
- yes
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- In the preliminary experiment of the mutagenicity test 4 animals (2 males and 2 females) were treated with 2000 mg/kg of the test item and observed for 48 hours.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2
- Control animals:
- not specified
- Details on study design:
- The acute oral toxicity of the test item was studied in a preliminary test of the in vivo mammalian erythrocyte micronucleus test.
- Dose descriptor:
- LD50
- Remarks:
- Not specified
- Remarks on result:
- other: Not specified
- Mortality:
- All the animals did not express toxic reactions.
- Clinical signs:
- other: All the animals did not express toxic reactions.
- Gross pathology:
- All the animals did not express toxic reactions.
- Other findings:
- All the animals did not express toxic reactions.
- Interpretation of results:
- other: Based on the results of the study, the test item should not be classified for acute oral toxicity according to the CLP Regulation (EC) No. 1272/2008.
- Conclusions:
- No toxic reactions were observed on mice during 48 hours following oral administration of the test item at the dose level of 2000 mg/kg. Based on the results of the study, the test item should not be classified for acute oral toxicity according to the CLP Regulation (EC) No. 1272/2008.
- Executive summary:
In the preliminary experiment of an in vivo mammalian erythrocyte micronucleus test in mice, 4 animals (2 males and 2 females) were treated with 2000 mg/kg of the test item and observed for 48 hours. Toxic effects were observed in none of the mice. Based on the results of the study, the test item should not be classified for acute oral toxicity according to the CLP Regulation (EC) No. 1272/2008.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- July 1997
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- EC Number:
- 305-897-5
- EC Name:
- 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- Cas Number:
- 95193-83-2
- Molecular formula:
- C18H11NO5S to C18H8NO11S3.3Na
- IUPAC Name:
- trisodium hydrogen bis(2-(1,3-dioxo-5-sulfonato-2,3-dihydro-1H-inden-2-yl)quinoline-8-sulfonate)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Deionized water
- Duration of treatment / exposure:
- 24 hours for all doses; 48 hours for the max. dose (2000 mg/kg).
- Frequency of treatment:
- Treatment was not repeated.
- Post exposure period:
- Not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw (total dose)
- Remarks:
- Treatment duration: 24 hours
- Dose / conc.:
- 1 000 mg/kg bw (total dose)
- Remarks:
- Treatment duration: 24 hours
- Dose / conc.:
- 2 000 mg/kg bw (total dose)
- Remarks:
- Treatment duration: 48 hours
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- CPA 40 mg/kg (24 hours)
Examinations
- Tissues and cell types examined:
- Not specified
- Details of tissue and slide preparation:
- Not specified
- Evaluation criteria:
- Not specified
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- There is no demonstration that the substance has reached the target cells.
- Additional information on results:
- Results toxicity study: in a preliminary experiment 4 animals (2 males and 2 females) were treated with 2000 mg/kg and observed for 48 hours. All the animals did not express toxic reactions.
Mutagenicity study: CPA induced 1.38 % of MN compared with the percentage of 0.075 of the animals treated with the deionised water. The test item did not induce MN in a frequency higher than the deionized water-treated animals (vehicle control). The study is considered inadequate for the evaluation as there is no demonstration that the substance has reached the target cells.
Applicant's summary and conclusion
- Conclusions:
- The study is considered inadequate for the evaluation as there is no demonstration that the substance has reached the target cells.
- Executive summary:
An in vivo mammalian erythrocyte micronucleus test was performed on NMRI mice. The test item was administered at the dose levels of 500, 1000 and 2000 mg/kg. The treatment lasted 24 hours for the 500 and 1000 mg/kg doses and 48 hours for the 2000 mg/kg dose. The test item did not induce MN in a frequency higher than the deionized water-treated animals (vehicle control). Nevertheless, the study is considered inadequate for the evaluation as there is no demonstration that the substance has reached the target cells.
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