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EC number: 237-185-4 | CAS number: 13680-35-8
- 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
- Study period:
- April - May 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-methylenebis[2,6-diethylaniline]
- EC Number:
- 237-185-4
- EC Name:
- 4,4'-methylenebis[2,6-diethylaniline]
- Cas Number:
- 13680-35-8
- Molecular formula:
- C21H30N2
- IUPAC Name:
- 4,4'-methylenebis(2,6-diethylaniline)
- Test material form:
- solid: crystalline
- Details on test material:
- - Physical state: see above
- Appearance: see above
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL
- Substance identification/name in the report: P5256
- Aspect: off-white crystalline solid
- Batch no.: E 29.3.83
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions: Room temperature, protected from light
- Stability under test conditions: stable
- Expiry date: not given
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd., The Field Station, Grimston, Aldbrough, Hull, HUll 4QE
- Age at study initiation: young adult rabbits, exact age not given
- Weight at study initiation: 2.57 - 2.84 kg
- Housing: individually housed in grid floor cages
- Diet (e.g. ad libitum): Standard Rabbit Diet, Special Diets Services Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): mains water
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20°C
- Humidity (%): 47 - 65%
- Air changes (per hr): single air conditioned room
- Photoperiod (hrs dark / hrs light): onstant daily photoperiod of 14 hours artificial light (06.00 - 20.00) and 10 hours darkness
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0.5 g test item
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TREATMENT PROCEDURE:
The back of each animal was clipped free of hair the day prior to treatment using electric veterinary clippers (Model A2, Oster, Milwaukee, Wisconsin). A portion of test article (0.5 g moistened with a few drops of distilled water) was applied to an area of skin approximately 6 cm2 on each animal and covered with a gauze patch. The patch was occluded and secured using a strip of impermeable adhesive tape (Sleek, Smith & Nephew, Welwyn Garden City, Herts.). A plastic collar was placed around the neck of each animal to prevent premature removal of the wrappings and ingestion of the test article. Four hours after application the patches were removed and the skin wiped with a disposable paper towel moistened with ater to remove any test article still remaining.
EVALUATION OF EFFECTS:
One hour after removal of the wrappings the skin reactions were scored using the Draize scale. The evaluation was repeated 24, 48 and 72 hours after removal of the patches.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Slight erythema was noted in one animal at the 1 hour reading, but this animal was normal at the 24 hour observation. All other animals were normal over the whole 72 hour observation period. A primary irritation index of 0.0 was obtained. No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Slight erythema was noted in one animal at the 1 hour reading, but this animal was normal at the 24 hour observation. All other animals were normal over the whole 72 hour observation period. A primary irritation index of 0.0 was obtained. Th test item was regarded as a non-irritant to rabbit skin. No corrosive effects were noted.
- Executive summary:
A study was carried out according to test methods EC B.4 and OECD 404 to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. 0.5 g test item, moistened with water, was applied to hair free clipped skin of three female rabbits. Duration of treatment was 4 hours, observation period 24, 48 and 72 hours.
A single 4 -hour application produced a primary irritation index of 0.0. The test item was classified as a non-irritant to rabbit skin. No corrosive effects were noted.
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