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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

There are’nt any available studies on humans for this endpoint.

The results of in vitro studies are negative:

- One Ames test (OECD 471, GLP compliant) conducted on a analogue substance (read-across).

- One In vitro Mammalian Chromosome Aberration test (OECD 473, GLP compliant) conducted on a analogue substance (read-across).

- One In vitro Mammalian Cell Gene Mutation Test (OECD 476, GLP compliant) conducted on a analogue substance (read-across)

A QSAR prediction for mutagenicity gave negative results

All available in vitro tests in genetic toxicity (GLP compliant and scored Klimishch 1) showed negative results. Thus there is no need to carry out in vivo studies in genetic toxicity. There is no reason to believe that the negative results would not be relevant to humans.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Direct Red 254 TEA salt (CAS No 64683-40-5 / EC 265-016-4) is defined as a mono-constituent substance with cations triethanolammonium.
The available toxicological data on this substance are insufficient to fulfil the data requirements for a REACH Annex VIII dossier.
In order to prevent unnecessary animal testing, the occurring data gaps on toxicity studies might be filled by applying read-across from the similar substance Direct Red 254 sodium salt (CAS No 6300-50-1 / EC 228-589-1). Both salts of Direct Red 254 are synthetized using the same raw materials and following the same manufacturing process.
The only difference between the query structure Direct Red 254 TEA salt (CAS 64683-40-5) and Direct Red 254 sodium salt (CAS 6300-50-1) is the counter ion. CAS 6300-50-1 is the result of a neutralization with NaOH, whilst the alkaline agent used in CAS No. 64683-40-5 is triethanolamine.
Both substances are identical in relation to the anionic components.

The read-across is based on the hypothesis that source and target substances have similar toxicological properties because both molecules have the following similarities: a) Identical raw materials; b) Identical manufacturing process; c) Identical anionic structure composition; d) Identical degradation products by reductive cleavage; e) Both have affinity to the same type of substrates/molecules. The substances are able to be adsorbed on the same type of substance, e.g. polysaccharides (cellulose), polyphenols (lignin) and proteins; f) Both substances have similar physicochemical properties

In summary, it is considered that both substances have the same mode of action with regard to the following endpoints: Acute Oral toxicity, Skin irritation, Eye irritation, Skin sensitisation, Mutagenicity and Repeated dose and reproduction / developmental (screening).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Read across is possible provided that there is no impact of impurities on the toxicological properties of the target and source chemicals. For both, impurities are comparable.
The composition and impurities of the target and source substances are shown in table 1 of the attached document to this record.

3. ANALOGUE APPROACH JUSTIFICATION

The target chemical Direct Red 254 TEA salt (CAS No 64683-40-5) is a mono-constituent substance, with cations triethanolammonium.
Direct Red 254 Sodium salt (CAS No 6300-50-1) is assumed as source chemical since it is identical to the target chemical Direct Red 254 TEA salt (CAS No 64683-40-5) in respect of the different chemical anionic component but varies in the cation. The physicochemical properties of both substances are nearly identical. No experimental data on absorption, distribution and excretion is available for the source and target substances and their hydrolysis products. The toxicokinetics assessment is based on the physicochemical properties and the available toxicological data of the substances.
The source chemical CAS No 6300-50-1 is ionisable and is assumed that will be dissociated in aqueous media or in biological fluids to the anionic component and free Na+ cation. Sodium ion is a naturally occurring cation in the body with a blood plasma concentration of 140 mmol/L. It is excreted with the urine and does not cause any toxic effects when administered in low concentrations.
In analogy to the source chemical also CAS No 64683-40-5 (target chemical) is expected to be dissociated shortly after absorption and the cation TEA+ is also assumed to be readily available in the body. The TEA+ cation can be assimilated to triethanolamine (CAS No 102-71-6).
Base on that the only difference between the target structure (CAS No 64683-40-5) and the source structure (CAS 6300-50-1) is the counter ion, and the influence to the human health toxicity, irritation and / or sensitisation effects due to the presence of TEA+ in the target chemical CAS No 64683-40-5 is not expected. Consequently, read-across to the source chemical CAS No 6300-50-1 is regarded as feasible.
A broad and more detailed explanation is included in the attached document in section 13 of this dossier.

4. DATA MATRIX
Two data matrix are included in the attached document in section 13 of this dossier: Matrix 1 (Toxicity data on the source and target substance) and Matrix 2 (Main potential metabolites data)
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
assessment report
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: In experiment strain TA 1535 showed irregular background growth in the control plates, therefore strain TA 1535 had to be repeated with and without metabolic activation
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Direct Red 254 TEA salt (CAS No 64683-40-5 / EC 265-016-4) is defined as a mono-constituent substance with cations triethanolammonium.
The available toxicological data on this substance are insufficient to fulfil the data requirements for a REACH Annex VIII dossier.
In order to prevent unnecessary animal testing, the occurring data gaps on toxicity studies might be filled by applying read-across from the similar substance Direct Red 254 sodium salt (CAS No 6300-50-1 / EC 228-589-1). Both salts of Direct Red 254 are synthetized using the same raw materials and following the same manufacturing process.
The only difference between the query structure Direct Red 254 TEA salt (CAS 64683-40-5) and Direct Red 254 sodium salt (CAS 6300-50-1) is the counter ion. CAS 6300-50-1 is the result of a neutralization with NaOH, whilst the alkaline agent used in CAS No. 64683-40-5 is triethanolamine.
Both substances are identical in relation to the anionic components.

The read-across is based on the hypothesis that source and target substances have similar toxicological properties because both molecules have the following similarities: a) Identical raw materials; b) Identical manufacturing process; c) Identical anionic structure composition; d) Identical degradation products by reductive cleavage; e) Both have affinity to the same type of substrates/molecules. The substances are able to be adsorbed on the same type of substance, e.g. polysaccharides (cellulose), polyphenols (lignin) and proteins; f) Both substances have similar physicochemical properties

In summary, it is considered that both substances have the same mode of action with regard to the following endpoints: Acute Oral toxicity, Skin irritation, Eye irritation, Skin sensitisation, Mutagenicity and Repeated dose and reproduction / developmental (screening).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Read across is possible provided that there is no impact of impurities on the toxicological properties of the target and source chemicals. For both, impurities are comparable.
The composition and impurities of the target and source substances are shown in table 1 of the attached document to this record.

3. ANALOGUE APPROACH JUSTIFICATION

The target chemical Direct Red 254 TEA salt (CAS No 64683-40-5) is a mono-constituent substance, with cations triethanolammonium.
Direct Red 254 Sodium salt (CAS No 6300-50-1) is assumed as source chemical since it is identical to the target chemical Direct Red 254 TEA salt (CAS No 64683-40-5) in respect of the different chemical anionic component but varies in the cation. The physicochemical properties of both substances are nearly identical. No experimental data on absorption, distribution and excretion is available for the source and target substances and their hydrolysis products. The toxicokinetics assessment is based on the physicochemical properties and the available toxicological data of the substances.
The source chemical CAS No 6300-50-1 is ionisable and is assumed that will be dissociated in aqueous media or in biological fluids to the anionic component and free Na+ cation. Sodium ion is a naturally occurring cation in the body with a blood plasma concentration of 140 mmol/L. It is excreted with the urine and does not cause any toxic effects when administered in low concentrations.
In analogy to the source chemical also CAS No 64683-40-5 (target chemical) is expected to be dissociated shortly after absorption and the cation TEA+ is also assumed to be readily available in the body. The TEA+ cation can be assimilated to triethanolamine (CAS No 102-71-6).
Base on that the only difference between the target structure (CAS No 64683-40-5) and the source structure (CAS 6300-50-1) is the counter ion, and the influence to the human health toxicity, irritation and / or sensitisation effects due to the presence of TEA+ in the target chemical CAS No 64683-40-5 is not expected. Consequently, read-across to the source chemical CAS No 6300-50-1 is regarded as feasible.
A broad and more detailed explanation is included in the attached document in section 13 of this dossier.

4. DATA MATRIX
Two data matrix are included in the attached document in section 13 of this dossier: Matrix 1 (Toxicity data on the source and target substance) and Matrix 2 (Main potential metabolites data)
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
assessment report
Key result
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Direct Red 254 TEA salt (CAS No 64683-40-5 / EC 265-016-4) is defined as a mono-constituent substance with cations triethanolammonium.
The available toxicological data on this substance are insufficient to fulfil the data requirements for a REACH Annex VIII dossier.
In order to prevent unnecessary animal testing, the occurring data gaps on toxicity studies might be filled by applying read-across from the similar substance Direct Red 254 sodium salt (CAS No 6300-50-1 / EC 228-589-1). Both salts of Direct Red 254 are synthetized using the same raw materials and following the same manufacturing process.
The only difference between the query structure Direct Red 254 TEA salt (CAS 64683-40-5) and Direct Red 254 sodium salt (CAS 6300-50-1) is the counter ion. CAS 6300-50-1 is the result of a neutralization with NaOH, whilst the alkaline agent used in CAS No. 64683-40-5 is triethanolamine.
Both substances are identical in relation to the anionic components.

The read-across is based on the hypothesis that source and target substances have similar toxicological properties because both molecules have the following similarities: a) Identical raw materials; b) Identical manufacturing process; c) Identical anionic structure composition; d) Identical degradation products by reductive cleavage; e) Both have affinity to the same type of substrates/molecules. The substances are able to be adsorbed on the same type of substance, e.g. polysaccharides (cellulose), polyphenols (lignin) and proteins; f) Both substances have similar physicochemical properties

In summary, it is considered that both substances have the same mode of action with regard to the following endpoints: Acute Oral toxicity, Skin irritation, Eye irritation, Skin sensitisation, Mutagenicity and Repeated dose and reproduction / developmental (screening).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Read across is possible provided that there is no impact of impurities on the toxicological properties of the target and source chemicals. For both, impurities are comparable.
The composition and impurities of the target and source substances are shown in table 1 of the attached document to this record.

3. ANALOGUE APPROACH JUSTIFICATION

The target chemical Direct Red 254 TEA salt (CAS No 64683-40-5) is a mono-constituent substance, with cations triethanolammonium.
Direct Red 254 Sodium salt (CAS No 6300-50-1) is assumed as source chemical since it is identical to the target chemical Direct Red 254 TEA salt (CAS No 64683-40-5) in respect of the different chemical anionic component but varies in the cation. The physicochemical properties of both substances are nearly identical. No experimental data on absorption, distribution and excretion is available for the source and target substances and their hydrolysis products. The toxicokinetics assessment is based on the physicochemical properties and the available toxicological data of the substances.
The source chemical CAS No 6300-50-1 is ionisable and is assumed that will be dissociated in aqueous media or in biological fluids to the anionic component and free Na+ cation. Sodium ion is a naturally occurring cation in the body with a blood plasma concentration of 140 mmol/L. It is excreted with the urine and does not cause any toxic effects when administered in low concentrations.
In analogy to the source chemical also CAS No 64683-40-5 (target chemical) is expected to be dissociated shortly after absorption and the cation TEA+ is also assumed to be readily available in the body. The TEA+ cation can be assimilated to triethanolamine (CAS No 102-71-6).
Base on that the only difference between the target structure (CAS No 64683-40-5) and the source structure (CAS 6300-50-1) is the counter ion, and the influence to the human health toxicity, irritation and / or sensitisation effects due to the presence of TEA+ in the target chemical CAS No 64683-40-5 is not expected. Consequently, read-across to the source chemical CAS No 6300-50-1 is regarded as feasible.
A broad and more detailed explanation is included in the attached document in section 13 of this dossier.

4. DATA MATRIX
Two data matrix are included in the attached document in section 13 of this dossier: Matrix 1 (Toxicity data on the source and target substance) and Matrix 2 (Main potential metabolites data)
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
assessment report
Key result
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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

Justification for classification or non-classification

Following the criteria as described Annex 1of Regulation (EC) No. 1272/2008, and based on the available data, the substance is not classified for genetic toxicity.