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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
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
Appearance: powder
Purity: 83.3 %
Stability of the test Compound: until October 1988
pH-value: 7.9 (1 g/L water)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Number and sex of animals used: 3 females
- Initial age: 12 - 14 weeks
- Initial body weight range: 2020-2410 g
- Individual identification: numbered ear tags; The cages were marked with sex, animal No., 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 sacrificed by intravenous injection of hypnotic T61 (Hoechst).
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- - Application of the Substance:
A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). The substance was water
moistened before application. Exposure duration was 4 hours.
- Study evaluation:
- Scoring of symptoms and local reactions: After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following
observation period.
- Mode of calculation: The index of primary cutaneous irritation was calculated as follows:
- the scores obtained for erythema and oedema at 1 hour, 24, 48 and 72 hours after removal of the patch, on the 3 rabbits examined, are summed up
- the sums of total oedema and erythema were divided by 12, when all the animals survived.
- the score obtained is defined as the "index of primary cutaneous irritation".
- Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
- Body weight: at beginning of acclimatization and end of test.
- Mortality: daily a.m.and p.m., once daily on weekends and holidays.
Interpretation of the primary-irritation index:
< 0.5 : non irritant
0.6 - 3.0 : slightly irritant
3.1 - 5.0 : irritant
5.1 - 8.0 : severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Remarks on result:
- other: Due to intensive staining by the test substance a scoring of the erythema values at 24 hours was not possible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: INDEX of skin irritation
- Basis:
- mean
- Time point:
- other: 1/24/48/72 h
- Score:
- 0.17
- Max. score:
- 8
- Irritant / corrosive response data:
- Due to intensive red staining by the test substance a scoring of the erythema values was not possible.
The dermal irritation was evaluated after the score for oedema formation only. The animals had recovered at the end of the observation period of 7 days. - Other effects:
- The animals showed a normal body weight development.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40147/E can be considered as not a skin irritant.
- Executive summary:
The skin irritation potential of the test substance was evaluated according to OECD Guideline 404. The test was performed on 3 female adult New Zealand White rabbits between the age of 12 - 14 weeks and weighing 2.020 to 2.410 kgs. Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq. cm,- by means of an electric clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). Exposure duration was 4 hours. The skin reaction was appraised after 1, 24, 48, 72 hours and 7 days upon removal of the dressings. The score obtained is defined as the "index of primary cutaneous irritation". Due to intensive red staining by the test substance a scoring of the erythema values was not possible. The dermal irritation was evaluated after the score for oedema formation only. The animals had recovered at the end of the observation period of 7 days. Index of skin irritation was calculated to be 2.33. However, the scores for erythema and edema do not meet the classification criteria proposed by CLP (Regulation 1272/2008). Hence, the substance FAT 40147/E can be considered as not a skin irritant.
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