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Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
EC number: 916-916-7 | CAS number: -
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
- EC Number:
- 916-916-7
- Molecular formula:
- not available
- IUPAC Name:
- Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
- Test material form:
- other: liquid
- Details on test material:
- no data on content available in the report
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: male7-8 weeks; female 9 weeks
- Fasting period before study: 16 hours prior to treatment
- Weight at study initiation: male ca 175 g; female ca 161 g
- Housing: in groups of 5
- Diet ad libitum
- Water . ad libitum
- Acclimation period: at keast 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Single oral application of 2000 mg/kg bw by gavage
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10 (5 males and 5 females)
- Control animals:
- no
- Details on study design:
- single oral application by gavage and observation of the animals for mortality, clinical signs and body weight development for 14 days. After termination the animals were examened gross-pathologically
- Statistics:
- the LD 50 was calculated according to the Method of "Moving averages" (Spärman and Kärber)
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: treatment was tolerated without mortality
- Mortality:
- 0/10
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- no gross pathological findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute toxicity of the test substance was evaluated according to the OECD TG 401 and GLP. 2000 mg/kg bw was applied to groups of 5 male and 5 female Wistar rats by gavage. No mortality occurred and no clinical signs were observed during the 14 -day observation period. Gross pathological examination after termination of the study did not show any findings which could be attributed to treatment. Thus. the LD50 is >2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
- Executive summary:
The acute toxicity of the test substance was evaluated according to the OECD TG 401 and GLP. 2000 mg/kg bw was applied to groups of 5 male and 5 female Wistar rats by gavage. No mortality occurred and no clinical signs were observed during the 14 -day observation period. Gross pathological examination after termination of the study did not show any findings which could be attributed to treatment. Thus. the LD50 is >2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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