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Reaction mass of Trisodium 4-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazenyl}benzenesulfonate and Trisodium 4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazenyl}benzenesulfonate
EC number: 944-218-2 | 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

Endpoint summary
Administrative data
Description of key information
FAT 40000 is to be considered as a non-irritant to the skin and eye of rabbits.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- other: Chbbibm: NZW (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH Postfach 1755 0·7950 Biberach a.d. Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: male : 2.8 kg females: 3.2 kg
- Housing: Individually in stainless steel cages (size: 86 x 54 x 33 em) equipped with feed hoppers and drinking water bottles.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 69/92 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum): Community tap water from FOllinsdorf, ad libitum
- Acclimation period: Five days under test conditions after veterinary examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark, music during the light period. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5 g of substance was applied.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- None
- Number of animals:
- 1 male
2 females - Details on study design:
- None
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40000 is to be considered as a non-irritant to the skin of rabbits.
- Executive summary:
A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40000, on the skin of the rabbits. 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm-tap water. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The application site was yellow stained up to 24 hours after the application; therefore the evaluation of a possible erythema formation was impeded. Because no erythema reactions were observed at 4 8 to 72 hrs and no edema reactions at 24 to 72 hrs after removing the bandages, the test was ended after the 72 hours evaluation. According to the EC classification of the results obtained, FAT 40000/G can be classified as non-irritant in albino rabbits.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Postfach 1755, D-7950 Biberach an der Riss
- Age at study initiation:15 weeks
- Weight at study initiation: male : 2.9 kg females: 2.4 - 2.8 kg
- Housing: Individually in stainless steel cages (size: 86 x 54 x 33 cm) equipped with feed
hoppers and drinking water bottles.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 69/92 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum. Results of analysis for
contaminants are included in this report.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are included in this report.
- Acclimation period: Five days under laboratory conditions after veterinary examination. Only animals without any visual signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3°C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux)/12 hours dark, music during the light period. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g of the test article
- Duration of treatment / exposure:
- None
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and 7 days after administration.
- Duration of post- treatment incubation (in vitro):
- None
- Number of animals or in vitro replicates:
- 1 male
2 females - Details on study design:
- None
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40000/G is considered to be non-irritant to the eyes.
- Executive summary:
In a study performed to determine the eye irritation potential of FAT 40000/G, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1 hour, 24 hours, 48 hours 72 hours. On test day 1, 0.1 g of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. FAT 40000/G is considered to be a non-irritant to the eyes.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40000, on the skin of the rabbits.0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm-tap water. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The application site was yellow stained up to 24 hours after the application; therefore the evaluation of a possible erythema formation was impeded. Because no erythema reactions were observed at 4 8 to 72 hrs and no edema reactions at 24 to 72 hrs after removing the bandages, the test was ended after the 72 hours evaluation. According to the EC classification of the results obtained, FAT 40000/G can be classified as non-irritant in albino rabbits.
In addition several other studies have been conducted involving different batches of the test item all proving non-irritant test results of the key study selected. Based on these data batch and production process specific effects on skin irritation can be ruled out.
Eye:
In a study performed to determine the eye irritation potential of FAT 40000/G, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1 hour, 24 hours, 48 hours 72 hours. On test day 1, 0.1 g of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower . lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. FAT 40000/G is considered to be a non-irritant to the eyes.
In addition several other studies have been conducted involving different batches of the test item all proving non-irritant test results of the key study selected. Based on these data batch and production process specific effects on eye irritation can be ruled out.
Justification for classification or non-classification
Based on the above stated assessment, FAT 40000 is to be considered as a non-irritant to the skin and eye of rabbits, hence no classification is warranted according toCLP (Regulation (EC) No 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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