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EC number: 202-430-6 | CAS number: 95-54-5
- 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

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only 1 animal per dose level, only one sex tested, necropsy on only 7 of the 9 animals conducted
- GLP compliance:
- not specified
Test material
- Reference substance name:
- o-phenylenediamine
- EC Number:
- 202-430-6
- EC Name:
- o-phenylenediamine
- Cas Number:
- 95-54-5
- Molecular formula:
- C6H8N2
- IUPAC Name:
- benzene-1,2-diamine
- Details on test material:
- - Name of test material (as cited in study report): ortho-Phenylenediamine (OPD).
- Samples were obtained by chipping pieces (mainly orange-brown) from the top layers of a solidified mass of orange-brown, yellow brown, and black layers, and grinding them into a uniform mixture. When the material was dispersed into a hydrophilic ointment USP, an orange paste usually formed. On one occasion, a yellow-brownish paste formed.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: 2.5-3.0 g
- Fasting period before study: None
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: hydrophilic ointment or polypropylene glycol
- Details on dermal exposure:
- TEST SITE: Rabbits were clipped at the trunk and fitted with collars.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours contact, wrappings were removed and the treated areas were washed with water and dried.
TEST MATERIAL
- For solids, paste formed: Yes; material suspended in polypropylene glycol and applied through a single layer of gauze wrapped around the clipped trunk. For higher doses, a 50% paste of the material in hydrophilic ointment, U.S.P., was applied directly to the clipped skin without gauze. After application, all rabbits were then wrapped with impervious film, gauze, and elastic bandage. - Duration of exposure:
- 24 hours
- Doses:
- 450, 670, 1000, 1500 (in polypropylene glycol), 1500, 2250 (yellow brown paste), 2250 (orange paste), 7500 and 11000 mg/kg
- No. of animals per sex per dose:
- one
- Control animals:
- no
- Details on study design:
- Animals were observed for 14 days before sacrifice. Necropsies were done on 7 of the 9 animals treated, and major tissues of 6 rabbits were saved for histopathological examination. No-necropsy rabbits: dosed at 11000 mg/kg and at 1500 mg/kg of the test substance in hydrophilic ointment; necropsy only - rabbit dosed at 1500 mg/kg of the test substance in polypropylene glycol.
Tissues examined included kidney, liver, trachea, lung, brain, testes, bone marrow, spleen, thymus, gastrointestinal tract and skin.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- other: Approximate Lethal Dose (ALD)
- Effect level:
- 1 500 mg/kg bw
- Mortality:
- Dose Level Mortality Ratio
(mg/kg)
450 (in 50% H.O.): 0/1
670 (in 50% H.O.): 0/1
1000 (in 50% H.O.): 0/1
1500 (in 15% DMP): 0/1
1500 (in 50% H.O.): 1/1
2250 (in 50% H.O.)
yellow brown paste: 0/1
2250 (in 50% H.O.)
orange paste: 1/1
7500 (in 50% H.O.): 1/1
11,000 (in 50% H.O.): 1/1 - Clinical signs:
- other: Clinical signs of toxicity observed included haematuria and abnormally dark urine, hyperemic eyelids, salivation, and debility. Local signs: Irritation in most cases was at least partially obscured by residual dye. However, the rabbit dosed at 1000 m
- Gross pathology:
- The following pathologic changes were observed at lethal doses:
Bladder - distended with red-tinged urine (gross exam)
Kidney - congestion (gross exam), inflammation and papillary necrosis (7500 mg/kg)
Liver - necrosis (2250 mg/kg)
Spleen - atrophy of lymphoid elements
Skin - necrosis of epithelium of deeper portions of hair follicles
Bone marrow - generalized necrosis
Thymus - lymphocytolysis
Small intestine - degeneration
The following pathologic changes were observed at non-lethal doses:
Kidney - papillary necrosis (2250 mg/kg)
Thymus - lymphoid atrophy at doses above 450 mg/kg
Bone marrow - generalized necrosis (2250 and 1000 mg/kg with regenerative response at 1000 mg/kg) - Other findings:
- In general, the orange-brown fraction appeared to be more toxic than the yellow-brown fraction in the skin absorption test.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Dermal ALD = 1500 mg/kg
- Executive summary:
The Approximate Lethal Dose (ALD) was 1500 mg/kg for rabbits when the test material was administered as 50% paste in hydrophilic ointment, U.S.P. Clinical signs of toxicity included haematuria and abnormally dark urine, hyperemic eyelids, salivation, and debility. Pathologic examination was done in most cases and showed frequent tissue changes in kidney, liver, bone marrow, lymphoid tissue, small intestine and skin. Local reaction was frequently obscured by the colour of the test material; however, temporary moderate to mild irritation from occluded 24 hour contact was sometimes noted. In general, the orange-brown fraction appeared to be more toxic than the yellow-brown fraction in the skin absorption test.
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