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EC number: 221-493-0 | CAS number: 3119-15-1
- 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:
- key study
- Study period:
- not reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Deviating from the OECD guideline 405, adopted 24 Feb. 87, the maximum administration dose of 100 mg per animals was exceeded in this study, since the planned administration volume of 0.1 ml per animal was erroneously applied without being adjusted to the maximum administration dose. This is not regarded to compromise the validity of the results since the severity of the effects observed in the individual animals was not correlated to the total dose administered.
- Deviations:
- yes
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-amino-2,4,6-triiodobenzoic acid
- EC Number:
- 221-493-0
- EC Name:
- 3-amino-2,4,6-triiodobenzoic acid
- Cas Number:
- 3119-15-1
- Molecular formula:
- C7H4I3NO2
- IUPAC Name:
- 3-amino-2,4,6-triiodobenzoic acid
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:Dr. Schenk, Schering AG, Germany, batch no: 37055008
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Weight at study initiation: males:.3 - 3.6 kg, females: 3.4 - 3.5 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days; during this period the animals were vaccinated against rabbit hemorrhagic disease (Arvilap®)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23° c
- Humidity (%): 56 - 60%
- Photoperiod (hrs dark / hrs light): 12-hour day/12-hour night cycle
IN-LIFE DATES: From: To: not reported
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Duration of treatment / exposure:
- Administration frequency: single
- Observation period (in vivo):
- 10 to 15 days
- Duration of post- treatment incubation (in vitro):
- 72 hours after treatment
- Number of animals or in vitro replicates:
- 2 male, 2 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: not reported
SCORING SYSTEM: not reported
TOOL USED TO ASSESS SCORE: not reported
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Reversibility:
- fully reversible within: 10 to 15 days
- Remarks on result:
- other: reddening
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.6
- Reversibility:
- fully reversible within: 10 to 15 days
- Remarks on result:
- other:
Any other information on results incl. tables
Findings |
|
|||
male |
female |
|||
A |
x-y |
A |
x-y |
|
Conjunctivae -reddening (all conjunctivae including conjunctiva sklerae) |
||||
clear injection of a some blood vessels |
18/2 |
|||
diffusely carmine, individual vessels not easy to discern |
7/2 |
|||
diffusely flesh-red |
1/1 |
|||
swelling (all conjuntivae including membrana nictitans) |
||||
slight |
16/2 |
1-14 |
13/2 |
1-10 |
clear with partial ectropium |
1/1 |
1 |
2/1 |
2-3 |
with half eyelid closure |
6/2 |
1-6 |
2/1 |
2-3 |
with more than half eyelid closure |
3/1 |
2-4 |
A = summation of positive findings/number of animals concerned
x-y = first - last day of occurrence of a finding
Animalnumber and sex | |||||
Location(finding) | Time-pointafter end of exposure | 27M | 33M | 20F | 23F |
Cornea(opacity) | 24hours | 0 | 0 | 0 | 0 |
48 hours | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | |
Individualmeanvalues: | 0 | 0 | 0 | 0 | |
Mean value of allanimals: | 0 | ||||
Iris(reddening,swelling,etc.) | 24hours | 0 | 0 | 0 | 0 |
48 hours | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | |
Individual meanvalues: | 0 | 0 | 0 | 0 | |
Mean value of all animals | 0 | ||||
Conjunctivae(reddening) | 24hours | 3 | 2 | 2 | 2 |
48 hours | 1 | 1 | 2 | 2 | |
72hours | 2 | 1 | 1 | 1 | |
Individual meanvalues: | 2 | 1.3 | 1.7 | 1.7 | |
Mean valueofallanimals | 1.7 | ||||
Conjunctivae (swelling) | 24hours | 4 | 3 | 3 | 2 |
48hours | 4 | 3 | 3 | 2 | |
72 hours | 4 | 1 | 1 | 1 | |
Individual meanvalues: | 4 | 2.3 | 2.3 | 1.7 | |
Mean valueofallanimals | 2.6 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The substance produced clear-cut irritation of the rabbit eye which was seen for more than 24 hours, but was fully reversible until day 10 to 15 after administration.
- Executive summary:
The eye of rabbits were exposed to the test substance according to OECD 405, with test concentration deviations (i.e. Deviating from the OECD guideline 405, adopted 24 Feb. 87, the maximum administration dose of 100 mg per animals was exceeded in this study, since the planned administration volume of 0.1 ml per animal was erroneously applied without being adjusted to the maximum administration dose. This is not regarded to compromise the validity of the results since the severity of the effects observed in the individual animals was not correlated to the total dose administered.) The substance produced clear-cut irritation of the rabbit eye which was seen for more than 24 hours, but was fully reversible until day 10 to 15 after administration. According to the EU criteria for general classification and labeling requirements for dangerous substances and preparations (2), the test item has to be labeled as an eye irritant since the mean value for chemosis was larger than 2.0.
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