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EC number: 916-632-3 | CAS number: -
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- intra peritoneal injection and subsequent observation
- GLP compliance:
- no
- Remarks:
- pre-guideliine study
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 270-629-5
- EC Name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68460-07-1
- Molecular formula:
- C28H22N8O8S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 272-559-0
- EC Name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68877-33-8
- Molecular formula:
- C28H23N9O7S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2,4-diaminophenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation:
High dose group: 150 - 180 g (mean 166 g)
Low dose group: 155 - 170 g (mean 162 g)
The animals of the mediium dose group were not weighed.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Remarks:
- deionized water
- Doses:
- A 50 % mixture of the test item with deionized water was prepared.
High dose group, 5000 mg/kg bw: 1 mL per 100 g bw
Medium dose group, 4000 mg/kg bw: 0.8 mL per 100 g bw
Low dose group, 2000 mg/kg bw: 0.4 mL per 100 g bw - No. of animals per sex per dose:
- 5 male animals per dose group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: the high and low dose group was weighed at the beginning, after 7 days and at the end of the observation period
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mL/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- no clinical signs were noted
- Body weight:
- The animals of the low and high dose group showed expected gains in body weight over the observation period.
Applicant's summary and conclusion
- Conclusions:
- the acute median lethal dose (LD50) of the test item in male rats by intraperitoneal application was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008. - Executive summary:
In a pre-guideline study the acute toxicity by intraperitoneal application was investigated in three dose groups with 5 male rats respectively. Dose levels of 2000, 4000 and 5000 mg/kg bw were administered as a 50 % mixture of the test item with deionized water. No mortalities were noted.
Thus, the acute median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
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