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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Acceptable, well-documented study report which meets basic scientific principles The registered substance is the reduced form of the test item used in this study (Indigo:CAS-No. 482-89-3; commercial name: D&C Blue No. 6, certified by U.S. FDA for coloring surgical sutures). Indigo Vat potassium salt oxidizes rapidly to indigo in the pressence of water and airborne oxygen.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1962
Report Date:
1962
Reference Type:
publication
Title:
Toxicology of Indigo - a review
Author:
Ferber KH
Year:
1987
Bibliographic source:
J. Environ. Pathol. Toxicol. Oncol. 7, 73 -84 (1987)

Materials and methods

Principles of method if other than guideline:
US Food and Drug Administration
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): D&C Blue 6
- Molecular formula (if other than submission substance): C16H10N2O2
- Molecular weight (if other than submission substance): 262.2628
- Smiles notation (if other than submission substance): O=C3c4ccccc4NC3=C2Nc1ccccc1C2=O
- InChl (if other than submission substance): InChI=1/C16H10N2O2/c19-15-9-5-1-3-7-11(9)17-13(15)14-16(20)10-6-2-4-8-12(10)18-14/h1-8,17-18H
- Structural formula attached as image file (if other than submission substance): see Fig. 1 section 4.1
- Substance type: active ingredient
- Physical state: solid
- Analytical purity: 95%
- Certified No. W4500
- Lot/batch No.: K7024

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: -
- Age at study initiation: -
- Weight at study initiation: 190 to 333 g
- Fasting period before study: 3 to 4 hours
- Housing: group-housing
- Diet: ad libitum
- Water: tap ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% MC (methyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1%, 10%, 25%
- Amount of vehicle (if gavage): 1, 3.16, 4, 12.64 ml/kg
- Justification for choice of vehicle: test item not soluble in water

MAXIMUM DOSE VOLUME APPLIED: 12.64 ml/kg
Doses:
10, 31.6, 100, 316, 1000, 3160 mg/kg bw nominal calculated to 100% pure indigo
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing:
- Mortality & toxic effects: immediately, 1, 4, 24 hours after dosing; daily thereafter
- BW: weekly
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Preliminary study:
NA
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
no deaths occurred
Clinical signs:
no effects besides blue feces at 24 hours fom 316 mg/kg onwards
Body weight:
no effects
Gross pathology:
no effects

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
There was no mortality and thus the acute oral LD50 was found to be greater than 3160 mg/kg bw
Executive summary:

Six groups of 5 male SD rats received certified D&C Blue No 6 at dose levels of 10, 31.6, 100, 316, 1000, 3160 mg/kg bw suspended in 0.5% metyl cellulose per oral avage. After a 7 day observation period, animals were necropsied. No mortality occured, and there were no clinical signs besides blue colored feces in the three highest dose groups. No macroscopic effects were noted. The acute oral LD50 was found to be greater than 3160 mg/kg bw in male rats.