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main component 1 (isomer 1): 2-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonapht-7-ylamino]-1,3,5-triazin-2-ylamino}-3-{6-fluoro-4-[3-(1,5-disulfonaphth-2-ylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 1 (isomer 2): 2-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-3-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 2: 2,3-bis-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 3: 2,3-bis-{6-fluoro-4-[3-(1,5-disulfonaphth-2-ylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt
EC number: 422-610-1 | 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
The test substance was found to be not irritating or corrosive to the skin, but caused irreversible damage to the eye.
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:
- 17 October 1996 to 12 December 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identity: FAT 40557/A
Batch-no.: PV1
Purity: 65 %
Appearance: Solid powder, red-brown
Stability of test article: stable at storage conditions; expiration date: September 30, 2002
Stability in Water: At least 48 hours
Expiration date: 30 September, 2002
Storage conditions: At room temperature at about 20 °C, away from direct sunlight. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D - 88397 Biberach / Riss
- Age at treatment: 15 weeks
- Weight at start acclimatization: Males: 2.7 kg, Females: 2.6 - 2.9 kg
- Weight at start of treatment: Males: 2.8 kg, Females: 2.6 - 3.0 kg
- Housing: Individually in stainless steel cages with an automatic cleaning and drinking system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: Pelleted standard Kliba 341, batch 70/96 rabbit maintenance diet ("Kliba", Kliba Muehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen ad libitum
- Acclimation period: Four days under test conditions after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70 (values above 70 % during cleaning process possible)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
In life phase: October 21-24, 1996 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- Test material was applied moistened in distilled water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 3 (1 male and 2 females)
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimetres (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration. On the day of treatment, 0.5 g of the test article was applied to approximately 6 cm² of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 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 test article was applied in such a position as to preclude oral ingestion after removal of the dressing. Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Irritation: FAT 40577/A showed a primary irritation score of 0.00 when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
Corrosion: No irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. - Other effects:
- Coloration: Initial orange staining, later fading to pale orange staining of the treated skin by the test article was observed.
Body weights: The body weight gain of all rabbits was within the normal range of variability.
Toxic symptoms/mortality: No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40557/A was found to be not irritating or corrosive.
- Executive summary:
In a GLP-compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5 g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the treated skin was flushed with water and observation were made for an additional 72 hours. The test substance showed a primary irritation score (24, 48, 72 hours) of 0.00 and local signs (24, 48, 72 hours) consisted of an erythema and edema score of 0.00 at all time points. No corrosive effect was evident on the skin. There were no mortality however clinical observation such as initial orange staining, later fading to pale orange staining of the treated skin by the test article was observed. Based on the study results, the test substance was found to be not irritating or corrosive.
Reference
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:
- 28 October 1996 to 12 December 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identity: FAT 40557/A
Batch-no.: PV1
Purity: 65 %
Appearance: Solid powder, red-brown
Stability of test article: stable at storage conditions; expiration date: September 30, 2002
Expiration date: 30 September, 2002
Storage conditions: At room temperature at about 20 °C, away from direct sunlight. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D - 88397 Biberach / Riss
- Age at start treatment: 15 weeks
- Weight at start acclimatization: Male: 2.8 kg, Females: 2.6-2.7 kg
- Weight at start treatment: Male: 2.9 kg, Females: 2.6-2.7 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: Pelleted standard Kliba 341 rabbit maintenance diet (batches 70/96 and 71/96) ad libitum from Kliba Mühlen AG, CH-4303 Kaiseraügst.
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under laboratory conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70 (values above 70 % during cleaning process possible)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 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.
- Observation period (in vivo):
- up to 21 days
- Number of animals or in vitro replicates:
- 3; 1 male, 2 females
- Details on study design:
- The eyes of the animals were examined for intactness once, one day prior to test article administration. Only those animals with no signs of ocular injury or irritation were used on the test. At treatment, 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. The eyes of each animal were examined 1, 24, 48 and 72 hours, as well as 7, 14 and 21 days after administration for ocular irritation.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Irritation: Slight to moderate reddening and slight swelling of the conjunctivae were noted in all animals. These findings were reversible after 7 days. Slight to moderate watery discharge was also seen in all animals, but was reversible after 48 hours.
Corrosion: No corrosion of the cornea was observed at any of the measuring intervals. FAT 40557/A showed a primary irritation score of 1.33, when applied to the conjunctival sac of the rabbit eye. - Other effects:
- Viability/mortality/clinical signs: No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
Coloration: Orange or light orange staining of the cornea, sclera and conjuctiva by the test article was observed. Staining of the conjunctivae persisted up to and including the end of the observation period.
Body weights: The body weight of the animals was within the normal range of variability. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the persistent staining of the conjunctivae up to and including the end of the observation period, FAT 40557/A is considered as irritant to eyes.
- Executive summary:
In a GLP-compliant eye irritation study, performed according to OECD guideline 405, FAT 40557/A (0.1 g) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined up to 21 days. There were no mortality observed while orange or light orange staining of the cornea, sclera and conjunctivae by the test article was observed. Staining of the conjunctivae persisted up to and including the end of the observation period. The test substance showed a mean chemosis score of 1 after 1 and 24 hours. A conjunctivae score of 2 was observed after 1 hour and a conjunctivae score of 1 was observed after 24, 48 and 72 hours. The chemosis and conjunctivae score were 0.00 at the other time points as were the cornea and iris scores during the whole observation period. No corrosion of the cornea was observed at any of the measuring intervals. However orange staining of the conjunctivae persisted up to and including the end of the observation period. Based on the persistent staining of the conjunctivae up to and including the end of the observation period, FAT 40557/A is considered as irritant to eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
In a GLP-compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5 g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the treated skin was flushed with water and observation were made for an additional 72 hours. The test substance showed a primary irritation score (24, 48, 72 hours) of 0.00 and local signs (24, 48, 72 hours) consisted of an erythema and edema score of 0.00 at all time points. No corrosive effect was evident on the skin. There were no mortality however clinical observation such as initial orange staining, later fading to pale orange staining of the treated skin by the test article was observed. Based on the study results, the test substance was found to be not irritating or corrosive.
Eye irritation/corrosion:
In a GLP-compliant eye irritation study, performed according to OECD guideline 405, FAT 40557/A (0.1 g) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined up to 21 days. There were no mortality observed while orange or light orange staining of the cornea, sclera and conjunctivae by the test article was observed. Staining of the conjunctivae persisted up to and including the end of the observation period. The test substance showed a mean chemosis score of 1 after 1 and 24 hours. A conjunctivae score of 2 was observed after 1 hour and a conjunctivae score of 1 was observed after 24, 48 and 72 hours. The chemosis and conjunctivae score were 0.00 at the other time points as were the cornea and iris scores during the whole observation period. No corrosion of the cornea was observed at any of the measuring intervals. However orange staining of the conjunctivae persisted up to and including the end of the observation period. Based on the persistent staining of the conjunctivae up to and including the end of the observation period, FAT 40557/A is considered as irritant to eyes.
Justification for classification or non-classification
Based on the findings in the skin irritation study, the test substance does not considered to be classified however, based on the findings in the eye irritation study, the test substance need to be classified as eye irritant according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) 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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