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EC number: 254-529-9 | CAS number: 39577-43-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella Mutagenicity Tests: II. Results From The Testing Of 270 Chemicals
- Author:
- Mortelmans,K, Haworth,S, Lawlor,T, Speck,W, Tainer,B And Zeiger,E
- Year:
- 1 986
- Bibliographic source:
- Environ. Mutagen. 8(Suppl. 7):1 -119, 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Gene mutation toxicity study was performed for Chlorpheniramine maleate to evaluate its mutagenic nature
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine but-2-enedioate
- Cas Number:
- 113-92-8
- Molecular formula:
- C16H19ClN2C4H4O4
- IUPAC Name:
- 3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine but-2-enedioate
- Details on test material:
- - Name of test material: Chlorpheniramine maleate
- Molecular formula: C16H19ClN2C4H4O4
- Molecular weight: 390.8647 g/mol
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Chlorpheniramine maleate
- IUPAC name: 3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine but-2-enedioate
- Molecular formula: C16H19ClN2C4H4O4
- Molecular weight: 390.8647 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Male Sprague-Dawley rats and male Syrian hamsters were routinely used for the S9 preparation of the liver fractions
- Test concentrations with justification for top dose:
- 0, 333, 666, 1000, 1666 or 3333 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: The test chemical was soluble in water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine (TA98; -S9), 2-aminoanthracene (all strains, +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hr
- Expression time (cells in growth medium): 48 hr
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: At least five dose levels of the chemicals were tested, with three plates per dose level.
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- 1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold;
2) nomutagenic response: when no increase in the number of revertants was elicited by the chemical;
3) questionable response: when there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants were not reproducible;
or when the response was of insufficient magnitude to support a determination of mutagenicity - Statistics:
- Mean and Standard error of mean
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA100, TA1535, TA1537, TA98
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: The chemical was initially tested with strain TA100 in the presence and the absence of the metabolic activation systems, over a wide dose range with an upper limit of 10 mg/plate, or less when solubility problems were encountered. Toxicity was evidenced by one or more of the following phenomena: appearance of his+ pinpoint colonies, reduced numbers of revertant colonies per plate, or thinning or absence of the bacterial lawn. Nontoxic chemicals were tested in the initial experiment up to the 10 mg/plate dose level, or to a level determined by their solubility. Toxic chemicals were tested up to a high dose which exhibited some degree of toxicity.
COMPARISON WITH HISTORICAL CONTROL DATA: No data
Any other information on results incl. tables
Table: Mutation data for the test chemical Chlorpheniramine maleate
Dose (µg/plate) |
TA100 |
|||||
NA |
10% HLI |
10% RLI |
||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
115 |
5.0 |
129 |
3.8 |
143 |
6.3 |
333 |
138 |
28.4 |
119 |
13.9 |
120 |
12.1 |
666 |
121 |
2.7 |
121 |
12.4 |
127 |
13.5 |
1000 |
106 |
3.0 |
114 |
12.9 |
127 |
4.0 |
1666 |
96 |
4.5 |
110 |
13.1 |
120 |
10.0 |
3333 |
0s |
0.0 |
75s |
2.8 |
98s |
8.4 |
Positive control |
242 |
6.2 |
775 |
83.4 |
441 |
3.7 |
Dose (µg/plate) |
TA1535 |
|||||
NA |
10% HLI |
10% RLI |
||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
9 |
1.3 |
7 |
0.7 |
7 |
0.4 |
333 |
10 |
0.9 |
5 |
1.5 |
9 |
4.6 |
666 |
10 |
1.5 |
6 |
1.7 |
9 |
2.9 |
1000 |
8 |
2.0 |
7 |
2.3 |
5 |
0.7 |
1666 |
7 |
2.6 |
5 |
0.6 |
6 |
0.5 |
3333 |
1s |
0.7 |
4 |
0.3 |
2s |
0.3 |
Positive control |
164 |
6.7 |
267 |
6.6 |
103 |
1.5 |
Dose (µg/plate) |
TA1537 |
|||||
NA |
10% HLI |
10% RLI |
||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
6 |
0.6 |
3 |
0.3 |
6 |
0.9 |
333 |
3 |
0.7 |
5 |
1.5 |
8 |
1.0 |
666 |
3 |
0.9 |
7 |
0.6 |
7 |
0.9 |
1000 |
4 |
0.6 |
5 |
1.5 |
6 |
1.5 |
1666 |
5 |
1.2 |
5 |
2.1 |
7 |
1.5 |
3333 |
1s |
0.0 |
6 |
1.2 |
2s |
0.9 |
Positive control |
283 |
53.3 |
341 |
3.0 |
96 |
8.3 |
Dose (µg/plate) |
TA98 |
|||||
NA |
10% HLI |
10% RLI |
||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
14 |
0.7 |
18 |
1.2 |
28 |
1.8 |
333 |
13 |
0.6 |
25 |
4.2 |
29 |
4.6 |
666 |
13 |
1.8 |
24 |
3.2 |
27 |
1.2 |
1000 |
19 |
2.6 |
26 |
4.3 |
26 |
3.5 |
1666 |
15 |
0.9 |
26 |
1.9 |
24 |
1.5 |
3333 |
0s |
0.0 |
24 |
3.5 |
14s |
1.2 |
Positive control |
354 |
21.2 |
608 |
27.5 |
344 |
19.7 |
S: slight clearing of background lawn
Applicant's summary and conclusion
- Conclusions:
- Chlorpheniramine maleate did not induce mutation in the Salmonella typhimurium strain TA100, TA1535, TA1537, TA98 both in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
- Executive summary:
Gene mutation toxicity study was performed for Chlorpheniramine maleate to evaluate its mutagenic nature. The study was performed as per the preincubation protocol using Salmonella typhimurium strain TA100, TA1535, TA1537, TA98 both in the presence and absence of S9 metabolic activation system at doses of 0, 333, 666, 1000, 1666 or 3333µg/plate. DMSO was used at the vehicle. The plates were incubated for 48 hrs after 20 mins preincubation before the evaluation of the revertant colonies could be made. Chlorpheniramine maleate did notinduce mutation in theSalmonella typhimurium strain TA100, TA1535, TA1537, TA98 both in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
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