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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Testing of 24 Foods, Drug, Cosmetic, and Fabric Dyes in the In Vitro and the In Vivo/ In Vitro Rat Hepatocyte Primary Culture/ DNA Repair Assays
Author:
Douglas Kornbrust and Thomas Barfknecht
Year:
1985
Bibliographic source:
Environmental Mutagenesis 7:101-120 (1985)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
DNA damage and/or repair toxicity performed on Sprague Dawley cesarean-derived rats
GLP compliance:
no
Type of assay:
other: In Vivo/ In Vitro Rat Hepatocyte Primary Culture/ DNA Repair Assays

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
EC Number:
219-746-5
EC Name:
Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
Cas Number:
2519-30-4
Molecular formula:
C28H21N5O14S4.4Na
IUPAC Name:
tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate
Constituent 2
Reference substance name:
Food black
IUPAC Name:
Food black
Details on test material:
- Name of test material (as cited in study report): Food black (2519-30-4)- Molecular formula (if other than submission substance): Not applicable- Molecular weight (if other than submission substance): Not applicable- Substance type: organic - Physical state: solid- Purity: 95%- Impurities (identity and concentrations):5%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Details on test animals and env conditionsTEST ANIMALS- Source: No data available - Age at study initiation: No data available- Weight at study initiation: 200-300 g- Assigned to test groups randomly: [no/yes, under following basis: ] No data available- Fasting period before study: No data available- Housing: No data available- Diet (e.g. ad libitum): Diet (ad libitum)- Water (e.g. ad libitum): Water (ad libitum)- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):12-hr light/dark cycles- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): 12-hr light/dark cyclesIN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Aqueous solution Or corn oil
Details on exposure:
No data available
Duration of treatment / exposure:
At specific times prior to the isolation of hepatocytes
Frequency of treatment:
One
Post exposure period:
No data available
Doses / concentrations
Remarks:
Doses / Concentrations:500 mg/kgBasis:no data
No. of animals per sex per dose:
No data available
Positive control(s):
Solvent Yellow 3 (0-aminoazotoluene)

Examinations

Tissues and cell types examined:
Rat hepatocytes
Details of tissue and slide preparation:
No data available
Evaluation criteria:
Net nuclear grains (NNG) were determined by counting the number of grains in each nuclei and subtracting the average number of grains present in three equal-size adjacent cytoplasmic areas.Net nuclear grains (NNG) were measured are as follows:Average net nuclear grain counts of 5 or greater were assumed to constitute a positive response. For those dyes that produced responses between zero and 5 average net nuclear grains, it was generally not possible to demonstrate a statistically significant difference from the control value within a given experiment. Therefore, these responses were judged to be equivocal. Net nuclear grain counts below zero were considered negative responses.
Statistics:
No data available

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

- Statistical evaluation:

 

Responses Produced by Various Dyes in the In Vivo/In Vitro HPC/DR Assay

Dye

Dose

(mg/kg b.w.)

Time PTPa

(hr)

Avg. NNGb

Percent cells<5 NNG

Res-

ponse

Food Black 1

500

2

15

-0.7 (±3.3)

-1.5 (± 2.8)

5

3

N

aTime that dye was administered prior to start of liver perfusion and isolation of hepatocytes.

bAverage net nuclear grains (as defined in the Methods section); mean + standard deviation from 60 cells.

CPercent of cells with > 5 net nuclear grains.

dP. Positive; WP, weak positive; E, equivocal; N, negative (as per the criteria defined in the methods section).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negativeThe genetic toxicity of Food black 1 (CAS No 2519-30-4) in Rat hepatocytes cell line was found to be negative.
Executive summary:

The genetic toxicity test was performed on rat using Food black 1.Rats given the 500 mg/kg ofFood black 1.Dye were administered to the animals as aqueous solutions or corn oil suspensions (for the non-water-soluble dyes), by gavage, at specific times prior to the isolation of hepatocytes.

Rat hepatocytes were isolated and cultured by the two-step in situ liver perfusion

Method.2 X 105viable hepatocytes were seeded into 25-mm wells and were allowed to attach to plastic cover slips for 2 hr.The cells were then incubated for 4 hr with [3H]-thymidine.

Net nuclear grains (NNG) were determined by counting the number of grains in each nuclei and subtracting the average number of grains present in three equal-size adjacent cytoplasmic areas.

Average net nuclear grain counts of 5 or greater were assumed to constitute apositiveresponse. For those dyes that produced responses between zero and 5 average net nuclear grains, it was generally not possible to demonstrate a statistically significant difference from the control value within a given experiment. Therefore, these responses were judged to beequivocal. Net nuclear grain counts below zero were considerednegativeresponses.

From the above table it was found that Avg. NNG forFood black 1 was found to be below zero.

 

Therefore, from the study in vivogenetic toxicity of Food black 1 (CAS No 2519-45-9)was found to be negative.