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EC number: 811-460-4 | CAS number: 53606-41-0
- 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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Vehicle:
- other: DAE433
- Vehicle:
- other: DAE433
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene (DNCB)
- Positive control results:
- The positive control substance DNCB produced positive LLNA response at an 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 statistically significant increase in ear weight. The negative control did not reveal any changes.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- the test substance, 2-methoxy-5-nitrophenyl acetate, provides positive sensitising response in LLNA assay.
- Executive summary:
The test substance, 2-methoxy-5-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 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-methoxy-5-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) for 3 consecutive days.
In pilot experiment the following concentrations of test substance in application forms were used: 30 %, 3 %, 0.3 % (w/v). According to the results of pilot experiment the 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-methoxy-5-nitrophenyl acetate caused a significant increase in radioisotope incorporation into the DNA of dividing lymphocytes. The Stimulation Index of the highest treated groups is > 3 (30% - 3.19). The value of DPM is statistically significantly increased compared to negative control. The Stimulation Index of the middle and the lowest treated groups (3 and 0.3 % w/v) is < 3 but the values of DPM are statistically significantly increased compared to negative control and overall dose-effect relationship is manifested.
The test substance did not cause statistically significant increase of ear weight and irritation to skin at all dose level – it means the test substance 2-methoxy-5-nitrophenyl acetate did not cause irritation to skin.
The animals exposed to the test substance at all concentrations showed no pathological and no other negative clinical symptoms of intoxication throughout the experiment.
The positive control item DNCB (concentration 0.5% (w/v) elicited a reaction pattern with statistically significant increase in Stimulation Index of cell proliferation and of ear weight, which was in congruence with his expected mode of action as a contact allergen. Appropriate performance of the assay in the test laboratory was then demonstrated.
Under the given test conditions, the test substance, 2-methoxy-5-nitrophenyl acetate, provides positive sensitising response in LLNA assay.
Reference
Under the given test conditions, the animals exposed to the tested concentrations of the test substance 2-methoxy-5-nitrophenyl acetate elicited sensitising response in LLNA. Positive results in cell proliferation revealed that the test substance 2-methoxy-5-nitrophenyl acetate could be a contact allergen in mice. Comparison of Stimulation Indexes between treated groups and control vehicle group revealed that the test substance 2-methoxy-5-nitrophenyl acetate caused a significant increase in radioisotope incorporation into the DNA of dividing lymphocytes. The Stimulation Index of the middle ant the lowest treated groups (3 and 0.3 % w/v) is less than 3 but the values of DPM are statistically significantly increased compared to negative control and overall dose-effect relationship is manifested. The test substance 2-methoxy-5-nitrophenyl acetate, provides positive sensitising response in LLNA assay.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Migrated from Short description of key information:
Comparison of Stimulation Indexes between treated groups and control vehicle group revealed that the test substance 2-methoxy-5-nitrophenyl acetate caused a significant increase in radioisotope incorporation into the DNA of dividing lymphocytes. The Stimulation Index of the highest treated group is > 3 (30% - 3.19). The value of DPM is statistically significantly increased compared to negative control. The Stimulation Index of the middle ant the lowest treated groups (3 and 0.3 % w/v) is < 3 but the values of DPM are statistically significantly increased compared to negative control and overall dose-effect relationship is manifested.
The test substance 2-methoxy-5-nitrophenyl acetate, provides positive sensitising response in LLNA assay.
Justification for classification or non-classification
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