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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database

Data source

Reference
Reference Type:
other: Authoritative database
Title:
Acute oral toxicity study of 2-Naphthalenesulfonic acid, 3-((4-(acetylamino)phenyl)azo)-4-hydroxy-7-((((5-hydroxy-6-(pheny- lazo)-7-sulfo-2-naphthalenyl)amino)carbonyl)amino)-, disodium salt (3441-14-3) in rats.
Author:
U.S. National Library of Medicine
Year:
2017
Bibliographic source:
Chemidplus Database,U.S. National Library of Medicine,2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute Oral toxicity test was carried out to study the effects of 2-Naphthalenesulfonic acid, 3-((4-(acetylamino)phenyl)azo)-4-hydroxy-7-((((5-hydroxy-6-(pheny- lazo)-7-sulfo-2-naphthalenyl)amino)carbonyl)amino)-, disodium salt (3441-14-3)on rats.
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Naphthalenesulfonic acid, 3-((4-(acetylamino)phenyl)azo)-4-hydroxy-7-((((5-hydroxy-6-(pheny- lazo)-7-sulfo-2-naphthalenyl)amino)carbonyl)amino)-, disodium salt
Cas Number:
3441-14-3
Molecular formula:
C35H27N7O10S2.2Na
IUPAC Name:
2-Naphthalenesulfonic acid, 3-((4-(acetylamino)phenyl)azo)-4-hydroxy-7-((((5-hydroxy-6-(pheny- lazo)-7-sulfo-2-naphthalenyl)amino)carbonyl)amino)-, disodium salt
Details on test material:
- Name of test material (IUPAC name): 2-Naphthalenesulfonic acid, 3-((4-(acetylamino)phenyl)azo)-4-hydroxy-7-((((5-hydroxy-6-(pheny- lazo)-7-sulfo-2-naphthalenyl)amino)carbonyl)amino)-, disodium salt
- Common name Direct Red 23
- Molecular formula: C35H27N7O10S2.2Na
- Molecular weight: 813.7335 g/mol
-Smiles notation:CC(=O)Nc1ccc(cc1)/N=N/c2c(cc3cc(ccc3c2O)NC(=O)Nc4ccc5c(c4)cc(c(c5O)/N=N/c6ccccc6)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+]
-InChl:1S/C35H27N7O10S2.2Na/c1-19(43)36-22-7-9-24(10-8-22)40-42-32-30(54(50,51)52)18-21-16-26(12-14-28(21)34(32)45)38-35(46)37-25-11-13-27-20(15-25)17-29(53(47,48)49)31(33(27)44)41-39-23-5-3-2-4-6-23;;/h2-18,44-45H,1H3,(H,36,43)(H2,37,38,46)(H,47,48,49)(H,50,51,52);;/q;2*+1/p-2/b41-39+,42-40+;;
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material (as cited in study report):Direct red 23
- Molecular formula :C35H27N7O10S2.2Na
- Molecular weight :813.7335 g/mol
- Substance type:organic

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
Details on study design:
- Duration of observation period following administration: No data available
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed in treated rats at 5000 mg/kg bw
Mortality:
No mortality was observed in treated rats at 5000 mg/kg bw
Clinical signs:
Clinical signs like changes in urine composition, somnolence (general depressed activity) were observed and after systemic exposure to skin and appendages (skin) dermatitis was observed.
Body weight:
No data available
Gross pathology:
Gross pathology was performed on kidney, ureter, and bladder.
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be >5000 mg/kg bw,when rats were treated with 2-Naphthalenesulfonic acid, 3-((4-(acetylamino)phenyl)azo)-4-hydroxy-7-((((5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl)amino)carbonyl)amino)-, disodium salt (3441-14-3) orally.
Executive summary:

Acute oral toxicity study was done in rats using test material 2-Naphthalenesulfonic acid, 3-((4-(acetylamino)phenyl)azo)-4-hydroxy-7-((((5-hydroxy-6-(pheny- lazo)-7-sulfo-2-naphthalenyl)amino)carbonyl)amino)-, disodium salt (3441-14-3).No Mortality was observed at dose 5000 mg/kg bw.Clinical signs like changes in urine composition,somnolence (general depressed activity) were observed and after systemic exposure to skin and appendages (skin) dermatitis was observed.Gross pathology was performed on kidney, ureter, and bladder.Hence,LD50 value was considered to be >5000 mg/kg bw,when rats were treated with 2-Naphthalenesulfonic acid, 3-((4-(acetylamino)phenyl)azo)-4-hydroxy-7-((((5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl)amino)carbonyl)amino)-, disodium salt (3441-14-3) orally.