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Diss Factsheets

Toxicological information

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 peer reviewed journal.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Short-term toxicity study of Green S in rats
Author:
S. A. CLODE, I. F. GAUNT, R. J. HENDY*, R. C. COTTRELLt and S. D. GANGOLLI
Year:
1987
Bibliographic source:
Food Chem. Toxic. Vol. 25, No. 12, pp. 969-975, 1987
Reference Type:
secondary source
Title:
TOXICOLOGICAL EVALUATION OF SOME FOOD COLOURS, ENZYMES, FLAVOUR ENHANCERS, THICKENING AGENTS, AND CERTAIN FOOD ADDITIVES
Author:
FAO/WHO Expert Committee
Year:
1975
Bibliographic source:
INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY, WHO FOOD ADDITIVES SERIES 6
Reference Type:
secondary source
Title:
Scientific Opinion-Scientific Opinion on the re-evaluation of Green S (E 142) as a food Additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
Author:
European Food Safety Authority (EFSA)
Year:
2010
Bibliographic source:
EFSA Journal 2010;8(11):1851

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 of Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
(CAS no.: 3087-16-9) in rats.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
EC Number:
221-409-2
EC Name:
Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
Cas Number:
3087-16-9
Molecular formula:
C27H26N2O7S2.Na
IUPAC Name:
Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Molecular formula :C27H26N2O7S2.Na
- Molecular weight: 576.623 g/mol
- Substance type:Organic
- Physical state:Solid
Specific details on test material used for the study:
- Name of the test material:Acid Green 50
- EC name: Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Molecular formula: C27H26N2O7S2.Na
- Molecular Weight: 576.623 g/mole
- Substance type: Organic
- Smiles: c12c(\C(c3ccc(N(C)C)cc3)=C3/C=C\C(=[N+](/C)C)C=C3)c(O)c(S(=O)(=O)[O-])cc1cc(S(=O)(=O)[O-])cc2.[Na+]

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed at 2000 mg/kg bw.
Clinical signs:
other: not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
LD50 was considered to be >2000 mg/kg bw, when rats were treated with Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt (CAS no.: 3087-16-9) via oral route.
Executive summary:

The acute oral toxicity study was conducted by using Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt (CAS no.: 3087-16-9) in rats at the concentration of 2000 mg/kg bw. No mortality was observed at 2000 mg/kg bw in rats. Therefore, LD50 was considered to be > 2000 mg/kg bw, when rats were treated with Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt via oral route.