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EC number: 946-967-0 | CAS number: -
- 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:
- Experiment start date - 11 April 1983; Experiment end date - 28 April 1983; Study completion date - 25 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide
- EC Number:
- 289-660-0
- EC Name:
- 3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide
- Cas Number:
- 89959-98-8
- Molecular formula:
- C18H21N6.Br
- IUPAC Name:
- Reaction mass of 3-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide and 5-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide
Constituent 1
- Specific details on test material used for the study:
- - Company code: FAT 31016/I
- Batch No.: RZ 3068/37
- Appearance: powder
- Stability of the test compound: until October 2012
- Test article received: October 25, 1982
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf.
The test was performed on 3 female New Zealand white rabbits weighing 2.3 to 2.6 kgs and aging between 12-14 weeks. They were housed individually in metal cages, were kept in a room maintained at a constant temperature of 20 ± 3 °C, at a relative humidity of 30-70 % and on a 12 hours light cycle day, with approximately 15 air changes/h. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG (Switzerland) and water. Prior to treatment they were acclimatized to the laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 17 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- - Application of the test article:
0.1 g of FAT 31016/I was placed into the conjunctival sac of the right eye of each rabbit, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
- Scoring and assessment of local reactions:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals
and taking into account the reversibility of the effect.
- Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays)
- Body weight: at begin of the acclimatisation and end of test
- Mortality: daily (a.m. and p.m. on working days, once daily on weekends and holidays)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 17 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 17 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.78
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 17 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.78
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 17 d
- Other effects:
- The body weight development was not affected by the application of the test article.
No other reactions to treatment were recorded during the whole observation period.
Any other information on results incl. tables
Irritation scores
Corneal opacity | |||||||
Animal | Observation time | ||||||
1 hour | 24 hours | 48 hours | 72 hours | 7 days | 17 days | ||
4 | 2 | 2 | 3 | 3 | 3 | 3 | |
5 | 2 | 2 | 3 | 3 | 4 | 4 | |
6 | 2 | 2 | 3 | 2 | 4 | 4 | |
Mean | 2.00 | 2.00 | 3.00 | 2.67 | 3.67 | 3.67 |
Iris | |||||||
Animal | Observation time | ||||||
1 hour | 24 hours | 48 hours | 72 hours | 7 days | 17 days | ||
4 | 1 | 1 | 1 | 1 | 2 | 2 | |
5 | 1 | 1 | 2 | 2 | 2 | 2 | |
6 | 1 | 1 | 1 | 2 | 2 | 2 | |
Mean | 1.00 | 1.00 | 1.33 | 1.67 | 2.00 | 2.00 |
Conjunctiva redness | |||||||
Animal | Observation time | ||||||
1 hour | 24 hours | 48 hours | 72 hours | 7 days | 17 days | ||
4 | 2 | 3 | 2 | 2 | 2 | 2 | |
5 | 3 | 3 | 3 | 3 | 3 | 3 | |
6 | 3 | 3 | 3 | 3 | 2 | 2 | |
Mean | 2.67 | 3.00 | 2.67 | 2.67 | 2.33 | 2.33 |
Chemosis | |||||||
Animal | Observation time | ||||||
1 hour | 24 hours | 48 hours | 72 hours | 7 days | 17 days | ||
4 | 2 | 3 | 2 | 2 | 2 | 2 | |
5 | 3 | 3 | 3 | 3 | 4 | 4 | |
6 | 3 | 3 | 3 | 3 | 2 | 2 | |
Mean | 2.67 | 3.00 | 2.67 | 2.67 | 2.67 | 2.67 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- FAT 31016/I was considered to be an eye irritant.
- Executive summary:
The eye irritation potential of FAT 31016/I was evaluated as per OECD Guideline 405.
The test was performed on 3 female rabbits. 0.1 g test substance was placed into the conjunctival sac of the right eye of the rabbits. The left eye was not treated and served as an untreated control. The eye irritation was appraised after 1 hour and on Days 1, 2, 3, 7 and 17 and was scored for each individual rabbit. Insertion of the substance in the eye did lead to irritation.
The mean scores (24, 48 and 72 hours) for corneal opacity, iris, conjunctival redness and chemosis were calculated to be 2.6, 1.33, 2.78 and 2.78 respectively. The individual scores were found to meet the criteria of classification as per CLP (Regulation EC No. 1272/2008). Further, the reactions were not reversible within 17 days. Hence, FAT 31016/I should be considered to be an eye irritant and should be classified in category 2, 'irritating to eyes'.
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