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[3-(Hydroxy-kO)-4-{[2-(hydroxy-kO) carbopolycyl-1-yl]diazenyl-kN1}-6-substituted-carbopolycyle-1-sulfonato(3-)]chromium, reaction products with hydrogen amino-4-hydroxy carbopolycyle-2-sulfonate, sodium 2-[(aminophenyl)sulfonyl]ethyl sulfate, amino-5-substituted-phenol and 2,4,6-trichloro-1,3,5-triazine
EC number: 454-620-5 | CAS number: 854270-57-8
- 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
Endpoint summary
Administrative data
Description of key information
The test substance was found to be not irritating or corrosive to the skin and 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC Ltd, CH-4452 Itingen, Switzerland
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, BP 0109, F-69592 L'Arbresle
- Age at treatment: 13 weeks (male), 11 weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 38/04, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 93/04) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g test substance moistened with approximately 0.5 mL purified water.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TREATMENT
Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again. Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.5 g of FAT 40821/A was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
OBSERVATIONS
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004 approximately 1, 24, 48 and 72 hours, as well as 7 days after the removal of the dressing, gauze patch and test item. To allow further examination of the test sites all animals were re-clipped on completion of the 48- and 72-hour examination. If evident, corrosive or staining properties of the test item were described and recorded. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.67
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.67
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Very slight to well-defined erythema were observed in all animals one hour after treatment and very slight erythema persisted up to 24- or 72-hour examinations in two animals, respectively. Very slight swelling (oedema) was noted in all animals one hour after treatment. No abnormal findings were observed on the treated skin of any animal 7 days after treatment, the end of the observation period.
- Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- - Slight black staining produced by the test item of the treated skin was observed in all animals at the observations performed 1 and 24 hours after treatment and persisted up to the 48-hour examination in two of these animals.
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- The body weights of all rabbits were considered to be within the normal range of variability. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Test substance is considered to be not irritating or corrosive to the rabbit skin.
- 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 dressing was removed and the skin was flushed with lukewarm tap water and observations were made for an additional 7 days. The test substance showed an edema score of 0 during the whole observation period. An erythema score of 1.67 and 0.67 was observed after 1 and 24 hours, respectively. An erythema score of 0.33 was observed after 48 and 72 hours. Erythema was fully reverisble within 7 days. Slight black staining was observed in all animals up to 48 hours. No corrosive effects were noted. Also no other clinical signs of test item related effects were observed. Under the conditions of this experiment, 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
- 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)
- Remarks:
- RCC Ltd, CH-4452 Itingen, Switzerland
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, BP 0109, F-69592 L'Arbresle
- Age at treatment: 11-12 weeks (male), 10-12 weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 74/04, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 2/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 17 days
- Observation period (in vivo):
- up to 17 days
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- TREATMENT:
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.1 g of FAT 40821/A 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 test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
OBSERVATIONS:
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 2004/73/EC, April 29, 2004 at approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, and 17 days after instillation. Additionally, ocular discharge, reddening of the sclerea and staining of conjunctivae, sclerea and cornea by the test item was assessed.
TOOL USED TO ASSESS SCORE:
Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland). - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours and 7, 10, 14, 17 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7, 10, 14, 17 days
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.33
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7, 10, 14, 17 days
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.67
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48, 72 hours and 7, 10, 14, 17 days
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Very slight corneal opacity affecting the whole area which was attributed to marked black staining caused by the test item was noted in one animal one hour after treatment. No abnormal findings were observed in the cornea of the remaining two animals and in the iris of any animal at any of the measurement intervals. Moderate reddening of the conjunctivae was noted in two animals at the 1-hour reading whereas the remaining animal was not assessable due to the staining produced by the test item and the opacity produced by the staining at the same reading time. Slight to moderate reddening of the conjunctivae was noted in all animals at the 24-hour examination and persisted as slight reddening of the comjunctivae up to the 72-hour reading. Slight to marked swelling (chemosis) of the conjunctivae with half-closed lids was observed in the three animals one hour after instillation and persisted as slight swelling in one animal until the 24-hour reading. Moderate reddening of the sclerea was present in two animals at the 1-hour reading whereas the remaining animal was not assessable due to the swelling produced by the test item. Slight to moderate reddening of the sclerea was noted in all animals at the 24-hour examination and persisted as slight reddening of the sclerea in one animal until the 48-hour reading and in the other animal up to the 72-hour reading. Slight to moderate ocular discharge was observed in all animals one hour after treatment and persisted as slight ocular discharge in one animal until the 24-hour examination. No abnormal findings were observed in the treated eye of any animal 7 days after treatment.
- No corrosion of the cornea was observed at any of the reading times. - Other effects:
- - Slight to marked black staining produced by the test item was noted in all animals at the 1-hour reading and persisted as slight black staining in two animals up to test day 14. Black remnants of the test item were observed in the eye or conjunctival sac of two animals one hour after treatment.
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. One animal screamed after the application.
- The body weights of all rabbits were considered to be within the normal range of variability. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered to be not irritating or corrosive to the rabbit eye.
- Executive summary:
In a GLP compliant eye irritation study, performed according to OECD guideline 405, test substance (0.1 g) was placed in the conjunctional sac of the left eye of 3 New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, and 17 days after test item instillation. The test substance showed a mean cornea score of 0.33 after 1 hour and 0 at the other time points (24 -72 hours, 7 -17 days). The conjunctivae score was 2 and 1.33 after 1 and 24 hours, respectively. After 48 and 72 hours, a score of 1 was observed and a score of 0 was present at the other time points (7 - 17 days). The chemosis score was 1.67 after 1 hour, 0.33 after 24 hours and 0 at the other time points (48, 72 hours and 7 - 17 days). The iris score was 0 during the whole observation period. No corrosion of the cornea was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
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 (RCC 2005). After 4 hours, the dressing was removed and the skin was flushed with lukewarm tap water and observations were made for an additional 7 days. The test substance showed a mean cornea score of 0.33 after 1 hour and 0 at the other time points (24 -72 hours, 7 -17 days). The conjunctivae score was 2 and 1.33 after 1 and 24 hours, respectively. After 48 and 72 hours, a score of 1 was observed and a score of 0 was present at the other time points (7 - 17 days). The chemosis score was 1.67 after 1 hour, 0.33 after 24 hours and 0 at the other time points (48, 72 hours and 7 - 17 days). The iris score was 0 during the whole observation period. No corrosion of the cornea was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.
Eye irritation:
In a GLP compliant eye irritation study, performed according to OECD guideline 405, test substance (0.1g) was placed in the conjunctional sac of the left eye of 3 New Zealand White rabbits (RCC 2005). Scoring of irritation effects was performedapproximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, and 17 days after test iteminstillation.The test substance showed a mean cornea score of 0.33 after 1 hour and 0 at the other time points (7 -14 days). The conjunctivae score was 2 and 1.33 after 1 and 24 hours, respectively. After 48 and 72 hours, a score of 1 was observed and a score of 0 was present at the other time points. The chemosis score was 1.67 after 1 hour, 0.33 after 24 hours and 0 at the other time points. The iris score was 0 during the whole observation period. No corrosion of the cornea was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.
Justification for selection of skin irritation / corrosion endpoint:
Only study available.
Justification for selection of eye irritation endpoint:
Only study available.
Justification for classification or non-classification
Based on the findings in the skin and eye irritation study the test substance does not need to be classified according to the Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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