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EC number: 210-233-1 | CAS number: 610-69-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Acetic acid, 2-nitrophenyl ester
- IUPAC Name:
- Acetic acid, 2-nitrophenyl ester
- Reference substance name:
- 2-nitrophenyl acetate
- EC Number:
- 210-233-1
- EC Name:
- 2-nitrophenyl acetate
- Cas Number:
- 610-69-5
- Molecular formula:
- C8H7NO4
- IUPAC Name:
- 2-nitrophenyl acetate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): 2-Nitrophenyl Acetate
- Physical state: solid light yellow
- Analytical purity: 95 % w/w
- Impurities (identity and concentrations):
Phenol <5.0 % (w/w)
2,4-dinitrophenol <5.0 % (w/w)
2,6-dinitrophenol <5.0 % (w/w)
Acetic acid <1.0 % (w/w)
Water <5.0 % (w/w)
2-nitrophenol <5.0 % (w/w)
- Lot/batch No.: 201408
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: The test substance will be stored in dry room in dark in
closed container at the room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Unětice 139, 252 62, Czech Republic, RČH CZ 21760118
- Age at study initiation: 8-10 weeks
- Weight at study initiation: at start of dosing: 18.12 - 20.40 g, in pilot exp: 16.59 - 17.32 g
- Housing: Monitored conditions, microbiologically defined background, according to internal SOP No.40
- Diet (e.g. ad libitum): Pelleted standard diet for experimental animals ad libitum (ST – 1, VELAS a.s., Hrabanov 535, 289 22 Lysá nad Labem, CZ801080-01). Microbiological control and content of nutrients is performed according internal SOP No. 72.
- Water (e.g. ad libitum): Drinking tap water ad libitum. Water quality corresponded to Regulation No. 252/2004 Czech Coll. Of Law, Health Ministry
- Acclimation period: 15 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: DAE 433 – mixture of 40% dimethylacetamide, 30% acetone and 30% ethanol
- Concentration:
- 0.75, 7.5, 75 % w/w
- No. of animals per dose:
- 5
- Positive control substance(s):
- other: Dinitrochlorobenzene (DNCB)
- Statistics:
- For statistical calculations the software Statgraphic ® Centurion (version XV, USA) was used. Statistical evaluation of measured parameters was performed at first by applying the non-parametric Kruskal-Wallis test for testing whether all group samples originate from the same distribution and then the non-parametric two-group Mann-Whitney rank test (probability level 0.05) for two-group comparisons.
Results and discussion
- Positive control results:
- The positive control substance DNCB produced a positive LLNA response at the exposure level expected to give an increase in the Stimulation Index SI ≥ 3 over the negative control group, which was in congruence with the expected mode of action of a contact allergen. The positive control also elicited a reaction pattern with significant increase in ear weight.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The value of SI for positive control group was increased. The SI was ≥ 3 (13.75) – the LLNA was efficient (see Table 8). The SI for the test groups treated with the test substance at all dose level is above the threshold, and stimulation index (SI) is > 3 (see Table 8).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The value of DPM for positive control group was increased. The value of DPM at all dose levels is statistically significantly increased compared to negative control and dose-effect relationship is manifested.
Any other information on results incl. tables
Table 8. Individual Activities and Calculated Values
Group (Anim.No.) | NC (1-5) | PC (6-10) | 75% (11-15) | 7.5% (16-20) | 0.75% (21-25) |
Activity (DPM) | 221.68 | 4123.86 | 2595.36 | 1110.13 | 954.67 |
250.84 | 2794.10 | 2501.64 | 1332.84 | 1156.16 | |
317.60 | 3113.31 | 2184.34 | 1269.68 | 1127.52 | |
230.10 | 3565.03 | 2266.43 | 1460.18 | 1229.62 | |
201.18 | 3202.12 | 2602.37 | 1982.02 | 1543.86 | |
mean | 244.28 | 3359.68* | 2430.03* | 1430.97* | 1202.37* |
SD | 44.69 | 507.82 | 193.19 | 332.83 | 215.90 |
SI | 1.00 | 13.75 | 9.95 | 5.86 | 4.92 |
Note:
* = statistically significant on probability level < 0.05 (Mann-Whitney test)
4.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the given test conditions the animals exposed to the test substance, 2-Nitrophenyl Acetate, elicited sensitising response in LLNA assay. Positive results in cell proliferation revealed that the test substance 2-Nitrophenyl Acetate could be a contact allergen in mice.
The test substance 2-Nitrophenyl Acetate, provides positive sensitising response in LLNA assay. - Executive summary:
The test substance, 2-Nitrophenyl Acetate, was tested for the assessment of skin sensitisation potential with the murine local lymph node assay. This study is a part of the test substance health hazard evaluation.
The Local Lymph Node Assay (LLNA) with the incorporation of 3H-methyl thymidine radionuclide was used. The testing was conducted according to the Method B.42 – Skin Sensitisation: Local Lymph Node Assay, Council Regulation (EC) No.640/2012, published in O.J. L 193, 2012.
In this study the contact allergenic potential of 2-Nitrophenyl Acetate was evaluated after topical application to female BALB/c mice. Mice were exposed to three concentrations of test substance suspended in vehicle DAE 433 (mixture of 40% dimethylacetamide, 30% acetone and 30% ethanol) for 3 consecutive days.
In pilot experiment the following concentrations of test substance in application forms were used: 75 %, 7.5 %, 0.75 % (w/v). According to the results of pilot experiment the same doses were confirmed for main study.
Primary proliferation of lymphocytes in the lymph node draining the site of application was evaluated using radioactive labelling of proliferating cells. The ratio of the proliferation in treated groups to that in vehicular controls, termed the Stimulation Index, was determined. The evaluation of ear weight was performed for elimination of false positive findings with certain skin irritants.
Comparison of Stimulation Indexes between treated groups and control vehicle group revealed that the test substance 2-Nitrophenyl Acetate caused a significant increase in radioisotope incorporation into the DNA of dividing lymphocytes of animals treated by the test substance at all concentrations. The Stimulation Index of the treated groups is > 3 (75% - 9.95; 7.5% - 5.86 and 0.75% - 4.92), and the value of disintegrations per minute (DPM) is significantly increased compared to negative control and overall a dose-effect relationship is observed.
The test substance did not cause increase of ear weight or other indication of irritation to skin at all dose levels.
The animals exposed to the test substance at all doses showed no pathological and no other negative clinical symptoms of intoxication throughout the experiment.
The positive control item Dinitrochlorobenzene (DNCB) as a contact allergen (concentration 0.5% (w/v) elicited the expected reaction pattern with significant increase in Stimulation Index of cell proliferation and of ear weight. Appropriate performance of the assay in the test laboratory was then demonstrated.
Under the given test conditions, the test substance, 2-Nitrophenyl Acetate, provides positive sensitising response in LLNA assay. The SI at all dose levels was > 3. Dose-response relationship and statistical significance was observed simultaneously.
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