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EC number: 240-357-1 | CAS number: 16245-77-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was not conducted under GLP. Limited information provided on animals used and environmental conditions. Study conducted outside of current guidelines. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment.
- Justification for type of information:
- Data is from experimental report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Details on test animals and environmental conditions not reported.
- Principles of method if other than guideline:
- The eye irritation study of test chemical was condcuted on rabbits according to OECD Guideline 405 (Acute Eye Irritation / Corrosion).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-phenylenediamine
- EC Number:
- 203-404-7
- EC Name:
- p-phenylenediamine
- Cas Number:
- 106-50-3
- Molecular formula:
- C6H8N2
- IUPAC Name:
- benzene-1,4-diamine
- Details on test material:
- - Purity: 99.5%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Age at study initiation: Not reported- Weight at study initiation: Not reported- Housing: Not reported- Diet (e.g. ad libitum): Not reported- Water (e.g. ad libitum): Not reported- Acclimation period: Not reportedENVIRONMENTAL CONDITIONS- Temperature (°C): Not reported- Humidity (%): Not reported- Air changes (per hr): Not reported- Photoperiod (hrs dark / hrs light): Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 10 mg of solid material
- Duration of treatment / exposure:
- Ten mg of solid test material was placed into the right conjunctival sac of each of 2 male albino rabbits. After 20 seconds, 1 treated eye was washed with tap water for 1 minute. The treated eye of the other rabbit was not washed.
- Observation period (in vivo):
- Observations of the cornea, iris and conjunctiva were made with an ophthalmoscope at 1 and 4 hours, and at 1, 2, 3, 7 and 14 days; Fluor-i-strip stain and a slit-lamp biomicroscope were used at examinations after the day of treatment.
- Number of animals or in vitro replicates:
- 2 albino male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): One treated eye was washed with tap water for 1 minute. The treated eye of the other rabbit was not washed.- Time after start of exposure: 10 mg of solid test material was placed into the right conjunctival sac of each of 2 male albino rabbits. After 20 seconds, 1 treated eye was washed with tap water for 1 minute.TOOL USED TO ASSESS SCORE: Ophthalmoscope at 1 and 4 hours, and at 1, 2, 3, 7 and 14 days; Fluor-i-strip stain and a slit-lamp biomicroscope at examinations after the day of treatment.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 3 days
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Irritation was observed in treated rabbits.
Any other information on results incl. tables
Table 1: Ocular Effects | ||||
Dose | Treatment | Cornea | Iris | Conjunctiva |
10 mg solid test material | Unwashed | A generalized area of slight cloudiness 1-4 hours. A small area of slight cloudiness at 1 day. | Moderate congestion 2-3 days. | Redness: Mild 1 hr.-1day and 3-7 days. Moderate at 2 days. Swelling: Slight at 1 hr. and mild 4 hrs.-1 day. Discharge: Mild 4 hrs.-1 days. |
10 mg solid test material | Washed | A generalized area of slight cloudiness 1 hr.-1 day and decreasing to a moderate area of slight cloudiness at 2 days and a small area of slight cloudiness at 3 days. | Moderate congestion 4 hrs.- 3 days. | Redness: Mild 1 hr.-7 days. Swelling: Slight 2-4 hrs. Discharge: None. |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test chemical was considered to be moderately irritating to the treated albino rabbits.
- Executive summary:
An eye irritation test was conducted to evaluate the ocular effects caused by the chemical OECD Guideline 405 (Acute Eye Irritation / Corrosion).
About 10 mg aliquot of the test substance produced generalized slight corneal cloudiness, moderate iritis and moderate conjunctivitis in an unwashed rabbit eye. An eye treated and promptly washed had generalized slight corneal cloudiness, moderate iritis and mild conjunctivitis. Both eyes were normal within 14 days after treatment.
Since the test material produced moderate ocular effects, it was considered as irritating to the eyes of treated rabbits.
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