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EC number: 281-866-9 | CAS number: 84045-65-8
- 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:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate
- Cas Number:
- 84045-65-8
- Molecular formula:
- C31H21Na3ClN7O10S3
- IUPAC Name:
- Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Company code: FAT 40'147/E
Batch No.: EN 94'066.32
Purity: 83.3 %
Appearance: powder
Stability of the test compound: until October 1988
pH-value: 7.9 (1g/l water)
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
Number and sex of animals used: 3 males
Initial age range: 12 - 14 weeks
Initial body weight range: 2150-2370 G
Individual identification: numbered ear tags. The cages were marked with animal No.and sex, the GU-Project No.and the company code of the test article.
Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20±3° C, relative humidity 30-70 %; 12 hours light/day, approximately 15 air changes/h.
Diet and water: Rabbit food NAFAG No.814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Euthanasia: At the end of the observation period, the animals were killed by the intravenous injection of hypnotic T61 (Hoechst).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and served as a control.
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Test Procedure:
0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal, 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. The left eye remained untreated and served as the control.
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 by means of a slit-lamp. The ocular irritation scores were evaluated.
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 acclimatization and at 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
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Due to intensive red staining by the test substance, scoring for corneal opacity was not possible till 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Due to intensive red staining by the test substance, scoring for corneal opacity was not possible till 7 days (animal no. 1), 48 hours (animal no. 2) and 72 hours (animal no. 3)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- The animals had recovered at the end of the observation period of 10 days.
- Other effects:
- The animals showed a normal body weight development.
Any other information on results incl. tables
Due to intensive red staining, scoring for corneal opacity and conjunctival redness was not possible at certain observation time points (see remarks in the 'Results of in vivo study' for details).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40147/E can be considered as not an eye irritant.
- Executive summary:
The eye irritation potential of the test substance was evaluated in a study conducted according to OECD Guideline 405. The test was performed on 3 male New Zealand White rabbits. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the right eye of the rabbits and the lidsthen held together for about one second in order to prevent loss of the test material. The left eye was not treated and served as an untreated control.The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period by means of a slit-lamp. Due to intensive red staining, scoring for corneal opacity and conjunctival redness was not possible at certain observation time points.
A slight irritation with conjunctival redness and chemosis was observed. The animals were free of findings by the day 10. The mean score for chemosis was calculated to be 1.8, with two animals having a mean score of 1.7 and one animal having a mean score of 2. Hence, the scores do not meet the classification criteria sert forth by CLP (Regulation 1272/2008). Based on the above findings, the test substance FAT 40147/E can be considered as not an eye irritant.
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