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EC number: 202-549-3 | CAS number: 96-98-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-nitro-p-toluic acid
- EC Number:
- 202-549-3
- EC Name:
- 3-nitro-p-toluic acid
- Cas Number:
- 96-98-0
- Molecular formula:
- C8H7NO4
- IUPAC Name:
- 4-methyl-3-nitrobenzoic acid
- Details on test material:
- Identity: Nitro-p-tolylsäure
CAS No: 96-98-0
Purity: 98,23 % (w/w)
Stability in solvent: > 72 h in DMSO and ethanol at room temperature
Storage: At room temperature
Expiration Date: January 19, 2011 (Statement of producer)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 25 g
- Housing:group
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness will be used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Frequency of applications:
- Duration:
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations:
- Evaluation (hr after challenge):
OTHER:
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10, 25%
- No. of animals per dose:
- 4
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: 1.42, 2.20, and 1.57
Any other information on results incl. tables
Test item concentration % (w/v) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
|||
--- |
BG I |
25 |
--- |
--- |
--- |
--- |
--- |
BG II |
39 |
--- |
--- |
--- |
--- |
0 |
1 |
2735 |
2703 |
8 |
337.9 |
|
5 |
2 |
3871 |
3839 |
8 |
479.9 |
1.42 |
10 |
3 |
5981 |
5949 |
8 |
743.6 |
2.20 |
25 |
4 |
4267 |
4235 |
8 |
529.4 |
1.57 |
BG=Background (1 ml 5% trichloroacetic acid) in duplicate 1=Control Group 2-4=Test Group S.I.=Stimulation Index
a) =The mean value was taken from the figures BG I and BG II b)=Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since all S.I.´s are below 3.
Viability / Mortality: No deaths occurred during the study period.
Clinical Signs: No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
Body Weights: The body weight of the animals, recorded prior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.
Ear Weights: The measured ear weights of all animals treated were recorded at necropsy. A weak increase in ear weights was observedand a statistically signifigance of the ear weight was determined (p=0.009).
Group
|
Test Item Concentration % (w/v) |
Ear Weight (punches, mg/animal) |
|
Mean |
SD |
||
1 |
- |
25.77 |
1.4 |
2 |
5 |
27.02 |
2.2 |
3 |
10 |
30.89 |
0.8 |
4 |
25 |
29.02 |
2.3 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Nitro-p-tolylsäure was not a skin sensitiser under the described conditions.
- Executive summary:
In the study the test item Nitro-p-tolylsäure dissolved in Dimethylformamide (DMF) was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 5, 10 and 25%. A weak increase in the ear punch biopsies was observed in the groups treated with 10 and 25% and a statistically signifigance of the ear weight was determined
(p=0.009).
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 1.42, 2.20 and 1.57 were determined with the test item at concentrations of 5, 10 and 25% in DMF, respectively.
The test item Nitro-p-tolylsäure was not a skin sensitiser in this assay.
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