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EC number: 200-453-6 | CAS number: 60-09-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment and in compliance with GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The HET-CAM Test is an alternative in vitro method for testing of severe eye/mucous membrane damage using the chorionallantoic membrane of fertilized, incubated hen eggs. Due to animal welfare reasons, the potential of severe irritation is determined in the HET-CAM in vitro system before deciding on a possible study in the rabbit as suggested in OECD Guideline 405.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF AG, Department of Experimental Toxicology and Ecology
Test material
- Reference substance name:
- 4-aminoazobenzene
- EC Number:
- 200-453-6
- EC Name:
- 4-aminoazobenzene
- Cas Number:
- 60-09-3
- Molecular formula:
- C12H11N3
- IUPAC Name:
- 4-[(E)-2-phenyldiazen-1-yl]aniline
- Details on test material:
- - Name of test material (as cited in study report): 4-Aminoazobenzol
- Analytical purity: 97% (analytical report No.: 07L00179)
- Test-substance No.: 07/0429-1
Constituent 1
Test animals / tissue source
- Species:
- other: hen
- Strain:
- other: white leghorn
- Details on test animals or tissues and environmental conditions:
- - Type of eggs: Fresh, fertilized hen eggs produced under controlled SPF conditions. White Leghorn, SPAFAS Inc., USA, SPF Premium
- Source: Charles River Deutschland GmbH, Extertal
- Weight at study initiation: 56.6–58.2 g
ENVIRONMENTAL CONDITIONS
Climate: Breeding in an incubator at constant temperature of 37.5°C (± 0.5°C) and a relative humidity of 62.5% (± 7.5%).
Automatic rotating device: Until including incubation day 8 and/or day 9, the eggs were rotated automatically 5 times a day. On the day before application the eggs were placed with the blunt end upward and were not rotated until preparation. The incubation conditions were checked daily. Deviations were recorded.
Candling of the eggs: The eggs were candled before the start of incubation and on the 9th and/or 10th day. Any defective or unfertilized eggs were
discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Positive control substances (aqueous solution of 0.1N NaOH and 1% Sodium dodecyl sulfate), which are known to cause moderate to severe irritation were tested, in order to demonstrate the sensitivity of the method.
- Amount / concentration applied:
- 25 μL (about 18 mg)
- Duration of treatment / exposure:
- 3.5 minutes
- Observation period (in vivo):
- After application of the test substance the chorionallantoic membrane was observed by means of a stereomicroscope until unambiguous irritation reactions were detected or up to a maximum time period of 3.5 minutes, respectively.
- Number of animals or in vitro replicates:
- 3 eggs
- Details on study design:
- EXPERIMENTAL PROCEDURE:
A bulk volume of 25 μL (about 18 mg) per egg of the ground solid test substance was applied on approximately the half of the membrane area, starting from the center. The visible parts of the membrane were observed. The test substance was removed by washing with 0.9% aqueous NaCl-solution after 3.5 minutes. A final assessment of the CAM was performed immediately after washing.
After application of the test substance the chorionallantoic membrane was observed by means of a stereomicroscope until unambiguous irritation reactions were detected or up to a maximum time period of 3.5 minutes, respectively.
The time of appearance (in seconds after application) of intravascular resp. extravascular coagulation and, if applicable, other reactions (haemorrhagia, vessel lysis) were determined.
EVALUATION OF RESULTS:
The evaluation depends on the solubility of the test substance, the tested concentrations and the time until appearance of unambiguous intravascular coagulation of middle-sized vessels or extravascular coagulation of the treated CAM, respectively.
The mean time until appearance of reaction over the eggs of a treatment group was calculated (mean time to coagulation = mtc in seconds).
- Oil-soluble test substances
mtc(100%) < 90: risk of serious damage to the eyes
or
mtc(100%) x 0.019 + mtc(10%) x 0.017 < 4.404: risk of serious damage to the eyes
mtc(100%) ≥ 90: no risk of serious damage to the eyes
- Water- and oil-insoluble test substances
mtc(100%) < 210: risk of serious damage to the eyes
mtc(100%) ≥ 210: no risk of serious damage to the eyes
- Water-soluble test substances
mtc(10%) < 90: risk of serious damage to the eyes
mtc(10%) ≥ 90: no risk of serious damage to the eyes
SCORING SYSTEM:
The evaluation of the reactions was performed according to the following grading:
0 No visible change
1 Slight reaction
2 Moderate reaction
3 Severe reaction
Results and discussion
In vivo
Results
- Irritation parameter:
- other: HET-CAM (Haemorrhagia and Coagulation)
- Basis:
- mean
- Time point:
- other: 210 s
- Score:
- 0
- Reversibility:
- other: no effects observed
- Other effects:
- no other effects
Any other information on results incl. tables
Concentration |
Egg no.: |
Observation period (seconds) |
Grading of effects observed after the test substanve removal by washing |
Additional findings |
||
Haemorrhagia |
Coagulation |
Haemorrhagia |
Coagulation |
|||
4-Aminoazobenzol |
1 |
210 |
210 |
0 |
0 |
none |
2 |
210 |
210 |
0 |
0 |
none | |
3 |
210 |
210 |
0 |
0 |
none |
Concentration |
Egg no.: |
Observation period (seconds) |
Grading of effects observed after the test substanve removal by washing |
Additional findings |
||
Haemorrhagia |
Coagulation |
Haemorrhagia |
Coagulation |
|||
Positive control (0.1N NaOH) |
1 |
24 |
48 |
2 |
2 |
iv |
2 |
24 |
42 |
2 |
2 |
iv |
iv: intravascular coagulation
Based on the results of this study and applying the evaluation criteria it is concluded, that 4-Aminoazobenzol, CAS 60-09-3 does not produce changes indicative for serious eye damage in the HET-CAM Test under the test conditions chosen.
Applicant's summary and conclusion
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