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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Lifetime toxicity/carcinogenicity study of FD & C Red No. 40 (Allura Red) in Sprague-Dawley rats
Author:
J.F. Borzelleca; J.W. Olson; F.E. Reno
Year:
1989
Bibliographic source:
Food and Chemical Toxicology Volume 27, Issue 11, 1989, Pages 701–705
Reference Type:
publication
Title:
Acute dermal application - rabbits, Red Z-4576.
Author:
Weir, R. J.
Year:
1967
Bibliographic source:
Unpublished report 165-119 by Hazelton Laboratories, Inc., submitted by Allied Chemical Corporation, 1967
Reference Type:
review article or handbook
Title:
DPIM: FAG100
Author:
Richard J. Lewis, Sr.
Year:
2007
Bibliographic source:
SAX (Sax's Handbook of Dangerous Industrial Materials);FCTOD7Food and Chemical Toxicology. 27 (1989), 701.

Materials and methods

Principles of method if other than guideline:
The toxicity study was examined to evaluate the acute toxic effects of administration of disodium 6-hydroxy-5-[(2-methoxy-4- sulphonato- m-tolyl) azo]naphthalene-2-sulphonate (ALLURA RED AC) (CAS No. 25956-17-6) in rabbits by the dermal route.
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
EC Number:
247-368-0
EC Name:
Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
Cas Number:
25956-17-6
Molecular formula:
C18H16N2O8S2.2Na
IUPAC Name:
disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material : disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC)
- Substance type: Organic
- Physical state: solid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Doses:
0,316, 1.0, 3.16 and 10 g/kg bw (0,316, 1000, 3160, 10000mg/kg bw/day)
No. of animals per sex per dose:
4 animals per group
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal median lethal dose (LD50) of disodium 6-hydroxy -5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC) in rabbit was observed to be >10000 mg/kg of body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that disodium 6-hydroxy-5 -[(2-methoxy-4-sulphonato-m-tolyl)azo] naphthalene-2- sulphonate (ALLURA RED AC) (CAS No. 25956-17-6) does not classify as an acute dermal toxicant.
Executive summary:

The toxicity study was examined to evaluate the acute toxic effects of administration of disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene -2-sulphonate (ALLURA RED AC) (CAS No. 25956-17-6) in rabbits by the dermal route. The acute dermal median lethal dose (LD50) of disodium 6-hydroxy -5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC) in rabbit was observed to be >10000 mg/kg of body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that disodium 6-hydroxy-5 -[(2-methoxy-4-sulphonato-m-tolyl)azo] naphthalene-2- sulphonate (ALLURA RED AC) (CAS No. 25956-17-6) does not classify as an acute dermal toxicant.