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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Pigment Red 48:1(Ba) is not genotoxic in vitro based on experimental data with Pigment Red 48:1(Ba) and pigments of the same category.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please see the category read-across justification in the category object.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Species / strain:
Chinese hamster lung (CHL/IU)
Metabolic activation:
with and without
Genotoxicity:
other: clastogenicity negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
Chinese hamster lung (CHL/IU)
Metabolic activation:
with and without
Genotoxicity:
other: polyploidy positive at precipitation
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please see the category read-across justification in the category object.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no independent repeat experiment. No allowance for azo-reduction.
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no independent repeat experiment
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
- Chemical name: 2-Naphthalenecarboxylic acid, 4-[5-chloro-4-methyl-2-sulfophenyl)azo]-3. hydroxy-, barium salt (1:1)
- Identity: SYMULER NEOTHOL RED 2BY
- Appearance: Red powder
- Storage conditions: Room temperature in the dark
- Lot number: 92688
- Expiry date: January 2003
- Date received: 11 January 2002
- Purity/Assay: >98%
Target gene:
histidine operon
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
50, 150, 500, 1500 and 5000 µg/plate
Vehicle / solvent:
water containing 0.15% agar
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
other: 2-Aminoanthracene and 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
Details on test system and experimental conditions:
METHOD OF APPLICATION: Pre-incubation method, duplicate plates per dose and strain

OTHER: no independent repeat experiment
Evaluation criteria:
Increase in mutant frequency compared to solvent control; comparison with historical controls
Statistics:
not required
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vitro mutagenicity in bacteria

Pigment Red 48:1(Ba) was found to be non-mutagenic in bacteria (DIC 2002). This study was performed following OECD testing guideline 471. No allowance was made for reductive metabolism of the azo function and no independent repeat experiment was included. The test item showed strong precipitation which is in line with the overall very low solubility.

No other data on Pigment Red 48:1(Ba) was available. Detailed experimental data is available for the analogue calcium salt Pigment Red 48:2(Ca), which is also poorly soluble, but of slightly better solubility than Pigment Red 48:1(Ba). Considering the better solubility and the absence of carcinogenic properties of soluble Barium chloride, data on Pigment Red 48:2(Ca) is adequate for read-across.

The mutagenicity of Pigment Red 48:2(Ca) in vitro was assessed in two tests applying both the standard assay with rat liver homogenate and the modified assay for azo compounds (Prival-assay). Tested samples were commercial products containing varying amounts of additives. With the limitation in the number of tester strains, the non-key study is reliable and valid in regard to design, positive and negative control and concentrations. The key study was performed following the latest OECD testing guideline (OECD 471, adopted July 12, 1997) and the principles of GLP and included the Prival assay modification to take into account reductive metabolism of the azo bond.

 

In vitro mutagenicity in mammalian cells

Mutagenicity in mammalian cells in vitro was investigated of Pigment Red 48:2(Ca) in a HPRT test following OECD testing guideline 476 (adopted July 21, 1997) and the principles of GLP. The test was performed with a sample synthesized without additives and a purity of 99.4%. No indication of a mutagenic effect was observed at concentrations up to 720mg/plate, at least the two highest concentrations being in the precipitating range. This is consistent with the absence of unscheduled DNA synthesis as tested with both with human fibroblasts (Puri 1985) and with primary hepatocytes prepared from arochlor1254-induced rats (Puri 1985). The latter studies were performed under GLP and in combination fulfil the requirements of OECD testing guideline 482 (adopted October 23, 1986). For the DNA-repair assays, concentrations were in similar range and also resulted in precipitation. Higher concentrations were too toxic for scoring. For these two studies, commercial samples with adequately high pigment content were tested.

 

In vitro clastogenicity in mammalian cells

Clastogenicity of Pigment Red 48:2(Ca) in mammalian cells was investigated in a guideline (OECD 473. adopted July 21, 1997) and GLP compliant study (Höpker 2007). The test was performed with a sample synthesized without additives and a purity of 99.4%. The highest evaluable concentrations were chosen based on visual observation of precipitates. No indication of clastogenicity or polyploidy were observed in either study.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genetic toxicity according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.