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EC number: 203-584-7 | CAS number: 108-45-2
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Structure activity relationships in skin sensitization using the murine local lymph node assay
- Author:
- Ashby J, Basketter DA, Paton D, and Kimber I
- Year:
- 1 995
- Bibliographic source:
- Toxicology (103), 177-194
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- m-phenylenediamine
- EC Number:
- 203-584-7
- EC Name:
- m-phenylenediamine
- Cas Number:
- 108-45-2
- Molecular formula:
- C6H8N2
- IUPAC Name:
- m-phenylenediamine
- Details on test material:
- - Purity: Not reported
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2.5, 5, 10%
- No. of animals per dose:
- Not reported
- Details on study design:
- Animals were exposed topically on the dorsum of both ears to 25 microliters of test substance or to an equal volume of vehicle alone. Treatment was performed daily for three consecutive days. Five days after the initiation of exposure, all mice were injected via the tail vein with 250 microliters of phosphate-buffered saline containing 20 µCi if tritiated thymidine. The mice were sacrificed 5 hours later, and the draining auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by beta scintillation counting was reported in disintegrations per minute. An SI was calculated for each chemical-treated group as the ratio of disintegrations per minute in the treated group (or mean disintegrations per minute when individual animals were assessed) to the disintegrations per minute or mean disintegrations per minute of the concurrent vehicle control group. The test substance was classified as a skin sensitizer if, at one or more test concentrations, it induced a threefold or greater incrrease in local lymph node proliferative activity when compared with concurrent vehicle-treated controls (SI ≥ 3).
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- EC3
- Remarks on result:
- other: 0.49% (estimated value derived by Gerberick GF, et al. (2005) from original data generated by Ashby J et al. (1995)).
- Parameter:
- SI
- Test group / Remarks:
- 2%
- Remarks on result:
- other: test to control (T/C) ratio of 11.7
- Parameter:
- SI
- Test group / Remarks:
- 5%
- Remarks on result:
- other: test to control (T/C) ratio of 15.4
- Parameter:
- SI
- Test group / Remarks:
- 10%
- Remarks on result:
- other: test to control (T/C) ratio of 19.2
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not reported
Any other information on results incl. tables
The ratio of 3HTdR incorporation into test lymph nodes relative to that recorded for control nodes (T/C ratio) was calculated for each test group.
% Concentration |
T/C Ratio |
2.5 |
11.7 |
5 |
15.4 |
10 |
19.2 |
In this test, a T/C ratio of ≥3 has been the main criterion for classifying a substance as a sensitizer in the LLNA.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- At three concentrations, 2%, 5%, and 10% the test substance is a sensitizing agent in the LLNA assay.
- Executive summary:
The sensitizing activity of 106 chemicals was tested in the local lymph node assay. The policy is to classify a chemical as potential sensitizers if that chemical provokes, at least one concentration, a 3-fold or greater increase in isotope incorporation compared with vehicle-treated controls. The test substance was tested at concentrations of 2, 5, and 10% and was found to have test to control (T/C) ratios of 11.7, 15.4, and 19.2, respectively. The overall stimulation index (EC3) was calculated to be 0.49%. Thus the test substance is a sensitizing agent in the LLNA assay.
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