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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is in compliance with OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
Test material
- 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-biphenylenedioxy)dianiline
- Substance type: Raw material for polymer
- Physical state: 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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Accredited supplier
- Age at study initiation: 34 to 37 weeks
- Weight at study initiation: 4.04 to 4.8 kg
- Housing: The rabbits were housed individually in plastic cages with perforated floors at the Eye Research Centre, Eye, Suffolk, England
- Diet (e.g. ad libitum): Each rabbit was offered 125 g of a standard laboratory rabbit diet per day (Rabbit GD Diet Pellets supplied by Highgate Farm)
- Water (e.g. ad libitum): Drinking water was provided ad libitum
- Acclimation period: 16 to 17 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20
- Humidity (%): 40 to 70
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: hair removed with clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 3 minutes, 1 hour (data not reported but archived) and 4 hours
- Observation period:
- 1, 24, 48, 72 hours after removal of the dressings
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm
- Type of wrap if used: 2-ply porous gauze pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water (30 to 40 °C)
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation:
No erythema = 0; Very slight erythema (barely perceptible) = 1; Well-defined erythema = 2; Moderate to severe erythema = 3; Severy erythema (beet redness) or eschar formation (injuries in depth) preventing grading of erythema = 4
Oedema formation:
No oedema = 0; Very slight oedema (barely perceptible) = 1; Slight oedema (edges of area well-defined by definite raising) = 2; Moderate oedema (raised approximately 1 millimetre) = 3; Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No dermal reaction was observed in any animal throughout the duration of the study.
- Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Table 1: Mean values for erythema and oedema 24, 48 and 72 hours after removal of dressings (4 hours of exposure)
Animal number and sex |
Erythema |
Oedema |
||
Test |
Control |
Test |
Control |
|
43, female |
0.0 |
0.0 |
0.0 |
0.0 |
50, female |
0.0 |
0.0 |
0.0 |
0.0 |
75, female |
0.0 |
0.0 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: according to the criteria of the ECETOC
- Conclusions:
- The Primary Irritation Index (PII) was calculated to be 0.0. 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline was classified as 'non-irritant' according to the criteria of the ECETOC and did not require labelling with the risk phrase R38, "irritating to skin", in accordance with Commission Directive 2001/59/EC.
- Executive summary:
A study was performed to assess the skin irritation potential of 3,3-(4,4-biphenylenedioxy)dianiline to the rabbit. The method was described in OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" Adopted 24 April 2002.
Three rabbits received a single semi-occlusive, dermal administration of approximately 0.5 g of the test substance as supplied for four hours and were observed for four days. No dermal reaction was observed in any animal throughout the duration of the study. The means of scores for these reactions at approximately 24, 48 and 72 hours after administration, calculated separately for each animal, are 0.0 (Erythema) and 0.0 (Oedema) for animal no. 43, 0.0 (Erythema) and 0.0 (Oedema) for animal no. 50 and 0.0 (Erythema) and 0.0 (Oedema) for animal no. 75. The Primary Irritation Index was calculated to be 0.0. Based on these findings the test substance was classified as 'non-irritant' according to the criteria of the ECETOC and did not require labelling with the risk phrase R38, "Irritating to skin", in accordance with Commission Directive 2001/59/EC.
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