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Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
EC number: 916-916-7 | 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
Bayscript Blaukomponente is not irritating to the skin of rabbits and not irritating to the mucous membranes 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually
- Diet ad libitum:
- Water ad libitum
- Acclimation period: at least 14 dqys
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20
- Humidity (%):50
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the opposite side of the back served as control
- Amount / concentration applied:
- 500 µl
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours. The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour - 14 days
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h - 14 d
- Score:
- ca. 0
- Max. score:
- 4
- Irritant / corrosive response data:
- the above results show that the test compound can be regarded as not irritating to the skin
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours.The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline. No erythema(score0 of mac 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
- Executive summary:
Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours.The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline. No erythema(score0 of mac 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMAL
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
- Humidity: 50 % - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the opposite eye served as control
- Amount / concentration applied:
- 100 µl
- Duration of treatment / exposure:
- 1 second
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour - 21 days
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour - 21 days
- Score:
- ca. 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour - 21 days
- Score:
- ca. 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits (score 0).
- Other effects:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits.(Score 0 ). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
- Executive summary:
Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits.(Score 0 ). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours. The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area was evaluated according to prescription of the guideline. No erythema (score 0 of max 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin.
Eye irritation test
Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second. The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control. Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits (Score 0). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits
Justification for selection of skin irritation / corrosion
endpoint:
This guideline study under GLP conditions is the only one which is
available and is evaluated with Klimisch Score 1
Justification for selection of eye irritation endpoint:
This guideline study under GLP conditions is the only one which is
available and is evaluated with Klimisch Score 1
Justification for classification or non-classification
Bayscript Blaukomponente is not irritating to the skin of rabbits and not irritating to the mucous membranes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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