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EC number: 947-917-0 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Negative in all tests conducted:
- Ames test with S. typhimurium TA 98, TA 100, TA 102, TA 1535 and TA
1537 (met. act.: with and without) (OECD TG 471, GLP); tested up to
cytotoxic concentrations
- Mammalian cell gene mutation assay with CHO cells (HPRT test) (met.
act.: with and without) (OECD Guideline 476, pre-GLP); tested up to
cytotoxic concentrations; read-across from DOPA-Glycinate
- In vitro mammalian chromosome aberration test with cultured human
lymphocytes (met. act.: with and without) (OECD Guideline 473, pre-GLP);
tested up to cytotoxic concentrations; read-across from DOPA-Glycinate
Link to relevant study records
- 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:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
- they are manufactured from similar or identical precursors under similar conditions
- they share structural similarities with common functional groups (corresponding to scenario 2 of the read-across assessment framework): both, the target and source substance, are aliphatic amines with C8-18 alkyl chains and acetate functions
- Two thirds (w/w) of the target substance Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (excluding the solvent water) are composed of the source substance DOPA-Glycinate. The remaining third of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid consists of other aliphatic amines and derivatives which are considered as structural analogues to those constituting the source substance DOPA-Glycinate and may therefore be expected to elicit comparable (eco)toxicological effects.
The read-across hypothesis is based on structural similarity of target and source substances. Based on available experimental data, including key physicochemical properties and data from acute toxicity, repeated dose toxicity, genotoxicity and short term ecotoxicity studies, the read-across hypothesis is supported by a quite similar toxicological profile of both substances.
(Eco)toxicological, physicochemical and environmental fate data are summarised in the data matrix; robust study summaries are included in the Technical Dossier in the respective sections.
Therefore, read-across from the existing ecotoxicity, environmental fate and toxicity studies conducted with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
Further details are attached to IUCLID section 13.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
For further details refer to IUCLID section 13.
3. ANALOGUE APPROACH JUSTIFICATION
For further details refer to IUCLID section 13.
4. DATA MATRIX
For further details refer to IUCLID section 13. - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain:
- other: human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- negative
- 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:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
- they are manufactured from similar or identical precursors under similar conditions
- they share structural similarities with common functional groups (corresponding to scenario 2 of the read-across assessment framework): both, the target and source substance, are aliphatic amines with C8-18 alkyl chains and acetate functions
- Two thirds (w/w) of the target substance Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (excluding the solvent water) are composed of the source substance DOPA-Glycinate. The remaining third of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid consists of other aliphatic amines and derivatives which are considered as structural analogues to those constituting the source substance DOPA-Glycinate and may therefore be expected to elicit comparable (eco)toxicological effects.
The read-across hypothesis is based on structural similarity of target and source substances. Based on available experimental data, including key physicochemical properties and data from acute toxicity, repeated dose toxicity, genotoxicity and short term ecotoxicity studies, the read-across hypothesis is supported by a quite similar toxicological profile of both substances.
(Eco)toxicological, physicochemical and environmental fate data are summarised in the data matrix; robust study summaries are included in the Technical Dossier in the respective sections.
Therefore, read-across from the existing ecotoxicity, environmental fate and toxicity studies conducted with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
Further details are attached to IUCLID section 13.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
For further details refer to IUCLID section 13.
3. ANALOGUE APPROACH JUSTIFICATION
For further details refer to IUCLID section 13.
4. DATA MATRIX
For further details refer to IUCLID section 13. - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- negative
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- Remarks:
- The use of E.coli WP2 or S. typhimurium TA102 was not mandatory at that time.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- + TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0, 0.12, 0.37, 1.11, 3.33, 6.67 and 10.0 mg/mL as test material; in a pretest for toxicity the test substance was very toxic for TA 98 at a dose level of 5.0 mg per plate and above, both in the absence and in the presence of the S-9 mix
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 3 d
NUMBER OF REPLICATIONS: 3 + independent repeat
DETERMINATION OF CYTOTOXICITY
- Method: background lawn - Evaluation criteria:
- A positive response in the assay system is taken to be a two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background spontaneous reversion rate
observed with the vehicle, together with evidence of a dose-response. - Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid did not show mutagenic activity in Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 either in the absence or in the presence of the S-9 mix, under the conditions employed in this evaluation.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (1983), Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were exposed to Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (27% aqueous solution) in water in concentrations of 0 (control), 0.12, 0.37, 1.11, 3.33, 6.67 and 10.0 mg/mL (in terms of test material) in all strains in the absence and presence of mammalian metabolic activation (rat liver S9 mix). The assay was performed using the plate incorporation method.
The test substance was tested up to cytotoxic concentrations.
In a pretest for toxicity the test substance was very toxic for TA 98 at a dose level of 5.0 mg per plate and above, both in the absence and in the presence of the S-9 mix. With strains TA 1535, TA 1537, TA 1538 and TA 98 slight toxicity was also observed at a dose level of 3.33 µg per plate.
The positive controls induced the appropriate responses in the corresponding strains. The mean numbers of revertant colonies in the negative controls were within the ranges of the historical control data.
There was no evidence of an increase in the number of revertant colonies that exceeded twice background in any of the tester strains. Therefore, test substance was considered to be non-genotoxic (non-mutagenic) in Salmonella tester strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 under the conditions employed.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21, 1997.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Remarks:
- + TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 3.16, 10.0, 31.6, 100, 316 and 1000 μg per plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 per concentration and experiment
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants by at least 50%, clearing or diminution of the background lawn or degree of survival of the treated cultures - Evaluation criteria:
- A test item is considered to show a positive response if
- the number of revertants is significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY) compared to the solvent control to at least 2-fold of the solvent control for TA98, TA100, TA1535 and TA1537 and 1.5-fold of the solvent control for TA102 in both independent experiments.
- a concentration-related increase over the range tested in the number of the revertants per plate is observed. The Spearman's rank correlation coefficient may be applied.
- Biological relevance of the results should be considered first.
Positive results from the bacterial reverse mutation test indicate that a substance induces point mutations by base substitutions or frameshifts in the genome of Salmonella typhimurium.
A test item for which the results do not meet the above mentioned criteria is considered as non-mutagenic in the AMES test. - Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid did not show mutagenic activity in Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 either in the absence or in the presence of the S-9 mix, under the conditions employed in this evaluation.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (1997), Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 were exposed to Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (26.6% aqueous solution) in water in concentrations of 0 (control), 3.16, 10.0, 31.6, 100, 316 and 1000 μg per plate in all strains in the absence and presence of mammalian metabolic activation (rat liver S9 mix). The assay was performed using the plate incorporation method; the confirmatory assay was performed as preincubation assay.
The test substance was tested up to cytotoxic concentrations. The substance was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 μg/plate were tested. Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted starting at a concentration of 1000 μg/plate in both experiments. Hence, 1000 μg test item per plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
In the main test, pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation at concentrations of 316 and 1000 μg AMPHOLYT 51/plate in all test strains. In addition, cytotoxicity (reduction of the number of revertants by more than 50%) was noted in both experiments without metabolic activation at the concentration of 100 μg/plate in test strain TA1535. The reduction of the number of revertants by more than 50% in test strain TA1537 in the plate incorporation test with metabolic activation at 3.16 μg/plate is considered to be caused by the high variation in individual counts and not due to cytotoxicity above all as no concentration response relationship was noted.
The positive controls induced the appropriate responses in the corresponding strains. The mean numbers of revertant colonies in the negative controls were within the ranges of the historical control data.
There was no evidence of an increase in the number of revertant colonies that exceeded twice background in any of the tester strains. Therefore, test substance was considered to be non-genotoxic (non-mutagenic) in Salmonella tester strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 under the conditions employed.
Referenceopen allclose all
From the results obtained in both experiments it appeared that incubation of the test substance with the bacteria did not increase the number of his+ revertants with S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100, either in the absence or in the presence of the S-9 mix.
At dose levels of 667.7 and 1000.0 µg per plate the test substance was toxic for all strains both in the absence and in the presence of the S-9 mix, as was seen from a reduced background lawn of bacterial growth. With strains TA 1535, TA 1537, TA 1538 and TA 98 slight toxicity was also observed at a dose level of 3.33 µg per plate.
The positive controls used in the present assays gave the expected strong increase in the number of his+ revertants, both in the absence and in the presence of the S-9 mix.
Preliminary study:
The test item was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 μg/plate were tested. Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted starting at a concentration of 1000 μg/plate in both experiments. Hence, 1000 μg test item per plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
Main study:
Six concentrations ranging from 3.16 to 1000 μg/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
Cytotoxicity
Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation at concentrations of 316 and 1000 μg/plate in all test strains. In addition, cytotoxicity (reduction of the number of revertants by more than 50%) was noted in both experiments without metabolic activation at the concentration of 100 μg/plate in test strain TA1535. The reduction of the number of revertants by more than 50% in test strain TA1537 in the plate incorporation test with metabolic activation at 3.16 μg/plate is considered to be caused by the high variation in individual counts and not due to cytotoxicity above all as no concentration response relationship was noted.
Mutagenicity
No increase in revertant colony numbers as compared with control counts was observed for the test item, tested up to cytotoxic concentrations in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation test and preincubation test).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A reverse gene mutation assay in bacteria according to OECD guideline 471 is available for the target substance Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid. A mammalian cell gene mutation assay (HPRT test), and an in vitro mammalian chromosome aberration test are available for the structurally closely related source substance DOPA-Glycinate. A justification for read-across is attached to IUCLID section 13.
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (1997), Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 were exposed to Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (26.6% aqueous solution) in water in concentrations of 0 (control),3.16, 10.0, 31.6, 100, 316 and 1000 μg per plate in all strains in the absence and presence of mammalian metabolic activation (rat liver S9 mix). The assay was performed using the plate incorporation method; the confirmatory assay was performed as preincubation assay.
The test substance was tested up to cytotoxic concentrations.The substance was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 μg/plate were tested. Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted starting at a concentration of 1000 μg/plate in both experiments. Hence, 1000 μg test item per plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
In the main test, pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation at concentrations of 316 and 1000 μg test item/plate in all test strains. In addition, cytotoxicity (reduction of the number of revertants by more than 50%) was noted in both experiments without metabolic activation at the concentration of 100 μg/plate in test strain TA1535. The reduction of the number of revertants by more than 50% in test strain TA1537 in the plate incorporation test with metabolic activation at 3.16 μg/plate is considered to be caused by the high variation in individual counts and not due to cytotoxicity above all as no concentration response relationship was noted.
The positive controls induced the appropriate responses in the corresponding strains. The mean numbers of revertant colonies in the negative controls were within the ranges of the historical control data.
There was no evidence of an increase in the number of revertant colonies that exceeded twice background in any of the tester strains. Therefore, test substance was considered to be non-genotoxic (non-mutagenic) in Salmonella tester strainsTA 98, TA 100, TA 102, TA 1535 and TA 1537under the conditions employed.
The mutagenic potential of DOPA-Glycinate was tested in the bacterial reverse mutation test using the plate incorporation assay. The study was conducted according to OECD guideline 471 (1997). The substance was tested up to cytotoxic concentrations.No increase in the number of revertant colonies was found in any of the tested strains with or without metabolic activation while the positive controls gave the expected increase in the mean number of revertant colonies.Under the conditions of this study, the test item dissolved in water was not mutagenic.
The clastogenic potential of DOPA-Glycinate was tested in human lymphocytes. The study was carried out according to OECD guideline 473 (1983). The substance was tested up to cytotoxic concentrations. The test item did not induce structural chromosome damage in cultured human lymphocytes either in the presence or in the absence of S9-mix.
The in vitro genotoxicity of DOPA-Glycinate was tested in Chinese hamster ovary cells (HPRT assay). The study was carried out according to OECD guideline 476 (1984). The substance was tested up to cytotoxic concentrations. In the absence and in the presence of a metabolic activation system, the test item did not induce a significant increase in the mutant frequency in both independent assays.
Based on the overall negative results of in vitro genotoxicity testing, teh target substance Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid may be regarded as void of any genotoxic potential.
No human data are available for genetic toxicity. However, there is no reason to believe that the negative results would not be relevant to humans.
Justification for classification or non-classification
Based on the available data, the target substance Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid does not need to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to mutagenicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.