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EC number: 218-542-3 | CAS number: 2177-70-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guideline/standards. GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his (Salmonella strains), trp (E. coli strain)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- first experiment: 0, 8, 10, 200, 1000, 5000 µg/plate
second experiment: 0, 312.5, 625, 1250, 2500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic actication
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduced bacterial growth - Evaluation criteria:
- Although not given in the study report, according to OECD guideline 471 a test item is considered mutagenic if:
- a clear and dose-related increase in revertant number occurs
- a biologically relevant positive response for at least one dose group occurs: in TA 100 and E. coli uvrA number of revertants at least twice as high as in solvent control; TA 98, TA 1535, TA 1537 at least three times higher number of revertants as in solvent control - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in TA100, TA1535, TA98
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
cytotoxicity (reduced bacterial growth) was observed in Salmonella strains TA100, TA1535 and TA98, but not in TA1537 and E. coli WP2uvrA-; however, the test item was tested up to limit concentrations - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
PHMA was not mutagenic in the bacterial reverse gene mutation assay when tested up to limit concentrations (5000 µg/plate). - Executive summary:
In a reverse gene mutation assay in bacteria similar to OECD guideline 471, S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 strains were exposed to PHMA (>99%) in DMSO at concentrations of 0, 8, 10, 200, 1000 and 5000 µg/plate in the first experiment and 0, 312.5, 625, 1250, 2500 and 5000 µg/plate in the second experiment in the presence and absence of mammalian metabolic activation (S9 mix). PHMA was tested up to limit concentrations (5000 µg/plate).
Cytotoxicity (reduced bacterial growth) was observed in Salmonella strains TA100, TA1535 and TA98, but not in TA1537 and E. coli WP2uvrA-. The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of induced mutant colonies over background.
PHMA was not mutagenic in this bacterial reverse gene mutation assay when tested up to limit concentrations.
Reference
S9 mix |
test item concentration [µg/plate] |
mean number revertants/plate |
||||
TA100 |
TA1535 |
E. coli WP2uvrA- |
TA98 |
TA1537 |
||
without |
0 |
110 |
15 |
35 |
20 |
13 |
8 |
111 |
13 |
30 |
26 |
12 |
|
10 |
116 |
14 |
31 |
22 |
12 |
|
200 |
103 |
13 |
27 |
20 |
14 |
|
1000 |
121 |
17 |
24 |
21 |
14 |
|
5000 |
83* |
12* |
22 |
11* |
13 |
|
positive control |
524 |
170 |
453 |
212 |
649 |
|
with |
0 |
136 |
16 |
31 |
36 |
12 |
8 |
135 |
15 |
30 |
33 |
12 |
|
10 |
134 |
15 |
28 |
39 |
11 |
|
200 |
137 |
17 |
28 |
33 |
13 |
|
1000 |
134 |
13 |
30 |
34 |
13 |
|
5000 |
133 |
15 |
33 |
33 |
14 |
|
positive control |
515 |
148 |
535 |
572 |
152 |
S9 mix |
test item concentration [µg/plate] |
mean number revertants/plate |
||||
TA100 |
TA1535 |
E. coli WP2uvrA- |
TA98 |
TA1537 |
||
without |
0 |
103 |
11 |
15 |
17 |
8 |
312.5 |
104 |
11 |
23 |
17 |
7 |
|
625 |
104 |
12 |
19 |
18 |
9 |
|
1250 |
116 |
11 |
17 |
20 |
8 |
|
2500 |
88 |
11 |
16 |
4 |
6 |
|
5000 |
53* |
8* |
19 |
5* |
5 |
|
positive control |
508 |
141 |
458 |
210 |
497 |
|
with |
0 |
125 |
14 |
18 |
30 |
13 |
312.5 |
123 |
12 |
21 |
26 |
13 |
|
625 |
118 |
12 |
21 |
33 |
13 |
|
1250 |
122 |
13 |
23 |
18 |
14 |
|
2500 |
123 |
12 |
18 |
24 |
13 |
|
5000 |
105 |
15 |
18 |
22 |
13 |
|
positive control |
536 |
174 |
501 |
449 |
157 |
* cytotoxic, reduced bacterial growth
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
One reliable (RL=2), relevant and adequate study to assess the genotoxic potential of PHMA is available:
In a reverse gene mutation assay in bacteria similar to OECD guideline 471, S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 strains were exposed to PHMA (>99%) in DMSO at concentrations of 0, 8, 10, 200, 1000 and 5000 µg/plate in the first experiment and 0, 312.5, 625, 1250, 2500 and 5000 µg/plate in the second experiment in the presence and absence of mammalian metabolic activation (S9 mix). PHMA was tested up to limit concentrations (5000 µg/plate).
Cytotoxicity (reduced bacterial growth) was observed in Salmonella strains TA100, TA1535 and TA98, but not in TA1537 and E. coli WP2uvrA-. The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of induced mutant colonies over background. PHMA was not mutagenic in this bacterial reverse gene mutation assay when tested up to limit concentrations.
Thus, based on the available information, PHMA is not genotoxic. There are no data gaps for the endpoint genotoxicity. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.
Justification for selection of genetic toxicity endpoint
OECD guideline study; GLP
Justification for classification or non-classification
Based on the available data PHMA does not need to be classified for mutagenicity according to the criteria given in regulation (EC) 1272/2008 or the former European directive on classification and labelling 67/548/EEC. Thus, no labelling is required.
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