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Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate
EC number: 941-533-7 | 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
No skin or eye irritating effects were noted.
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:
- 1987
- 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
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: HC: NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.4 - 3.6 kg
- Housing: individual mesh cages, Type III
- Diet (e.g. ad libitum): ssniff K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- The duration of exposure was 4 h. The treated area was washed with water after end of exposure period.
- Observation period:
- 24, 48 and 72 h after removal of the patches.
- Number of animals:
- 3 females
- Details on study design:
- TEST PROCEDURE
About 24 h before the start of the study the hair in the contralateral sides of the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 6 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g test substance in water. The substance was applied over the whole surface of a 6 x 6 cm patch on a piece of surgical plaster (i.e. specially produced by BeierSdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with water.
Examinations of the skin took place 24, 48 and 72 h after removal of the patches.
Erythema, eschar formation and edema were evaluated numerically according to the Draize scoring system. All other changes of the skin were recorded.
SCORING SYSTEM:
Erythema and eschar formation
No erythema........................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................1
Well-defined erythema ......................................................................................................2
Moderate to severe erythema............................................................................................3
Severe erythema (beet redness) to eschar formation (injuries in depth) preventing
grading of erythema...........................................................................................................4
Edema - swelling
No edema..............................................................................................................................0
Very slight edema (barely perceptible).............................................................................1
Slight edema (edges of area well defined by definite raising).......................................2
Moderate edema (raised approximately 1 mm) ..............................................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure)...4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritating to rabbit skin.
- Executive summary:
A study was performed to assess the skin irritation potential of the test substance in female New Zealand albino rabbits according to OECD Guideline 404, in compliance with GLP. 500 mg of the test substance pasted with water was evenly applied over the whole surface of a 6 x 6 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area of about 6 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of the test substance were carefully removed with warm tap water. Animals were scored for irritation reactions after 24, 48 and 72 h. No signs of irritation were observed during the whole observation period. Overall mean scores for dermal irritation were calculated to be 0.0 for erythema and eschar formation and 0.0 for edema formation. Under the test conditions, the test substance was considered to be non-irritating to rabbit skin (Ruf, 1987a).
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:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: HC: NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.1 - 3.7 kg
- Housing: individual mesh cages, Type III
- Diet (e.g. ad libitum): ssniff K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- 40 mg in 100 µL
- Duration of treatment / exposure:
- Duration of exposure was 24 h. The treated eye was rinsed with saline solution at the end of the exposure period.
- Observation period (in vivo):
- 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- TEST PROCEDURE
40 mg of the test substance was administered once to the conjunctival sac of the left eye of the rabbits in 100 µL solution. In each case the untreated eye served as a control. 24 h after administration, the treated eye was washed out thoroughly with saline solution.
The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded.
In case of positive findings in the iris and cornea at 24 h and at later evaluation points, one drop of a 1% fluorescein solution was applied to the corneal surfaces, then washed out with saline solution. The eyes were thereafter analysed with UV light. - Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- 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:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. These effects were linked to mechanical irritation.
- Other effects:
- Slight tear production was seen in one rabbit at the 24 h observation point.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was not considered to be irritating to the rabbit eyes.
- Executive summary:
A study was conducted to assess the eye irritation potential of the test substance in one New Zealand albino female rabbit according to OECD Guideline 405, in compliance with GLP. A single dose of 40 mg test substance was applied to the conjunctival sac of the left eye of the animal in 100 µL solution. The treated eye was washed at 24 h after administration. The untreated eye served as a control. The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded. Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. One rabbit showed light tear production at 24 h. These effects were linked to mechanical irritation and were reversible before end of the study. Under the test conditions, the test substance was not considered to be irritating to the rabbit eyes (Ruf, 1987b).
Reference
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 assess the skin irritation potential of the test substance in female New Zealand albino rabbit according to OECD Guideline 404, in compliance with GLP. 500 mg of test substance pasted with water was evenly distributed over the whole surface of a 6 x 6 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area of about 6 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of test substance were carefully removed with warm tap water. Animals were scored for irritation reactions after 24, 48 and 72 h. No signs of irritation were observed during the whole observation period. Overall mean scores for dermal irritation were calculated to be 0.0 for erythema and eschar formation and 0.0 for edema formation. Under the test conditions, the test substance was considered to be non-irritating to skin (Ruf, 1987a).
Eyes
A study was conducted to assess the eye irritation potential of the test substance in one New Zealand albino female rabbit according to OECD Guideline 405, in compliance with GLP. A single dose of 40 mg test substance was applied to the conjunctival sac of the left eye of the animal in 100 µL solution. The treated eye was washed at 24 h after administration. The untreated eye served as a control.The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded. Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. These effects were linked to mechanical irritation and reversible before end of the study. Under the test conditions, the test substance was not considered to be irritating to the eyes (Ruf, 1987b).
Justification for classification or non-classification
Based on the results of in vivo studies, no classification for skin and eye irritation is warranted for the test substance according to CLP (EC/1272/2008) criteria.
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