Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-102-1 | CAS number: 105112-76-3
- 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)
- Rationale for reliability incl. deficiencies:
- other: The test was conducted in compliance with OECD Guideline for Testing Chemicals No. 429 "Skin Sensitization: Local Lymph Node Assay". Adopted 24 April 2002. There was no deviation from the protocol.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- m-BP
- IUPAC Name:
- m-BP
- Reference substance name:
- 3-{[4'-(3-aminophenoxy)-[1,1'-biphenyl]-4-yl]oxy}aniline
- EC Number:
- 700-102-1
- Cas Number:
- 105112-76-3
- Molecular formula:
- C24H20N2O2
- IUPAC Name:
- 3-{[4'-(3-aminophenoxy)-[1,1'-biphenyl]-4-yl]oxy}aniline
- Details on test material:
- - Name of test material (as cited in study report): 3,3-(4,4-diphenylenedioxy)dianiline
- Substance type: Raw material for polymer
- Physical state: Off-white powder
- Analytical purity: >99 %
- Lot/batch No.: 20070501
- Expiration date of the lot/batch: End April 2008
- Storage condition of test material: Room temperature
- Other: Date of receipt was 28 August 2007
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England
- Age at study initiation: twelve weeks
- Weight at study initiation: 19.1 to 23 g
- Housing: animals were housed inside a barriered rodent facility (Building F21, Room 12). They were housed individually in polycarbonate cages with woodflake bedding. The mice were given Nestlets for environmental enrichment.
- Diet (e.g. ad libitum): free access to standard rodent diet (RM1(E) SQC expanded pellet)
- Water (e.g. ad libitum): potable water from the public supply was freely available via polycarbonate bottles fitted with sipper tubes
- Acclimation period:six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 40 to 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10, 25 and 50 % w/v
- No. of animals per dose:
- Four
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility:
- Irritation:
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response:
TREATMENT PREPARATION AND ADMINISTRATION:
The maximum practical concentration for pinna dosing was 50 % w/v in DMF. Based on this information the following concentrations were selected for the study:
10, 25 and 50 % w/v
The dosage for the positive control group was chosen based on previous study conducted at this laboratory using HCA in DMF and was 25 % v/v.
Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 μl of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was applied to the dorsal surface of each ear using an automatic micropipette. The test substance was spread over the entire dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner, and a further group of four mice received HCA (positive control) in the same manner.
In the main study, five days following the first topical application of test substance (Day 6) all mice were injected via the tail vein with 250 μl of phosphate buffered saline containing 3H-methyl Thymidine† (3HTdR: 80 μCi/ml) giving a nominal 20 μCi to each mouse. The injection into the tail vein was carried out using a plastic syringe and needle (26 gauge) after the mouse had been heated in a warming chamber.
† Specific activity 2.0 Ci/mmol, concentration 1.0 mCi/mL
All animals were observed daily for signs of ill health or toxicity. The ears were also examined for signs of irritation.
In the main study, five hours following the administration of 3HTdR on Day 6 all mice were humanely killed by carbon dioxide asphyxiation and the draining auricular lymph nodes excised and pooled for each experimental group. 1.0 ml of phosphate buffered saline was added to the pooled lymph nodes for each group. The animals were then discarded and no further investigations were carried out. The following procedures were carried out with the lymph nodes from these animals only.
A single cell suspension of lymph node cells (LNC) was prepared by gentle mechanical disaggregation through a stainless steel gauze (200 mesh size). The pooled LNC were then washed by adding 10 ml phosphate buffered saline, pelleted at 190 x g for 10 minutes and resuspended. The cells were washed twice again and resuspended in 3 ml trichloroacetic acid (TCA: 5%) following the final wash.
After overnight incubation with 5% TCA at 4°C, the precipitate was recovered by centrifugation and resuspended in 1 ml 5% TCA and transferred to 10 ml Ultima gold scintillation fluid on Day 7. 3HTdR incorporation was measured by β-scintillation counting. The proliferative response of LNC was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes
relative to that recorded for control nodes (test/control ratio). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The stimulation index for the positive control substance hexyl cinnamic aldehyde (HCA), was 5.5 which proved to demonstrate the reliability and sensitivity of this assay to detect skin sensitization potential in this laboratory.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The stimulation indices were obtained by comparing the proliferation in the vehicle (DMF) treated group with the values from the three test groups. These indices were 0.7, 0.6 and 0.6 for the three test groups. The stimulation for the postive control substance HCA was 5.5.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The DPM in the control group (DMF only) showed a dpm of 2256 (282 dpm per node). The test group with a concentration of 10 % w/v of the test substance in DMF showed a dpm of 1657 (207 dpm per node). The test group with a concentration of 25 % w/v showed a dpm of 1288 (161 dpm per node). The test group with a concentration of 50 % w/v showed a dpm of 1348 (168.5 dpm per node).The positive control group with a concentration of 25 % v/v hexyl cinnamic aldehyde had a dpm of 12359 (1545 dpm per node).
Any other information on results incl. tables
Table 1: Group dpm/node and test/control ratios (stimulation indices)
Group |
Concentration in vehicle % w/v |
Dpm |
Number of lymph nodes per group |
Dpm/node |
Test/control ratio |
Result* |
1 |
DMF |
2255.85 |
8.0 |
281.98 |
n.a. |
n.a. |
2 |
10 |
1656.95 |
8.0 |
207.12 |
0.7 |
Negative |
3 |
25 |
1288.25 |
8.0 |
161.03 |
0.6 |
Negative |
4 |
50 |
1348.25 |
8.0 |
168.53 |
0.6 |
Negative |
5 |
HCA 25 % v/v |
12359.1 |
8.0 |
1544.88 |
5.5 |
Positive |
* Test/control ratios of 3 or greater indicate a positive result
n.a.: not applicable
dpm: Disintegrations per minute (less background count of 71.35 dpm)
DMF: Dimethylformamide (vehicle control)
HCA: Hexyl cinnamic aldehyde (positive control)
Table 2: Group dpm/node and test/control ratios (stimulation indices)
Group |
Concentration in vehicle % w/v |
Dpm |
Number of lymph nodes per group |
Dpm/node |
Test/control ratio |
Result* |
1 |
DMF |
2255.85 |
8.0 |
281.98 |
n.a. |
n.a. |
2 |
10 |
1656.95 |
8.0 |
207.12 |
0.7 |
Negative |
3 |
25 |
1288.25 |
8.0 |
161.03 |
0.6 |
Negative |
4 |
50 |
1348.25 |
8.0 |
168.53 |
0.6 |
Negative |
5 |
HCA 25 % v/v |
12359.1 |
8.0 |
1544.88 |
5.5 |
Positive |
* Test/control ratios of 3 or greater indicate a positive result
n.a.: not applicable
dpm: Disintegrations per minute (less background count of 71.35 dpm)
DMF: Dimethylformamide (vehicle control)
HCA: Hexyl cinnamic aldehyde (positive control)
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- 3,3-(4,4-biphenylenedioxy)dianiline is not regarded as a potential skin sensitiser.
- Executive summary:
The skin sensitisation potential of 3,3 -(4,4 -biphenylenedioxy)dianiline using the murine local lymph node assay (LLNA) was assessed in compliance with OECD Guideline for Testing of Chemicals No. 429 "Skin Sensitization: Local Lymph Node Assay".
In each phase of the study, the female CBA mice were treated by daily application of 25 L of each of one of these concentrations (10, 25, or 50% w/v), or control (vehicle or positive), to the dorsal surface of both ears for three consecutive days. The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assess five days following the initial application, by measurement of the incorporation of 3H-methyl Thymidine by beta-scintillation counting of LNC suspensions. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio - stimulation index). The test substance is regarded as a sensitizer if at least once concentration of the chemical results in a three-fold grater increase in 3HTdR incorporation compared to control values. In this assay the test/control ratios obtained for 10, 25 and 50% w/v were 0.7, 0.6, 0.6 respectively which indicates that 3,3 -(4,4 -biphenylenedioxy)dianiline did not show the potential to induce skin sensitization. The test substance therefore is not regarded as a potential skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.