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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
- 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
Skin Irritation: Not irritating (OECD 404, rabbit)
Eye Irritation: Not irritating (OECD 405, rabbit)
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out in compliance with GLP according to Guideline 84/449/EWG, B.4 and OECD 404. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG, B.4, OECD 404 (1981)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- not specified
- Amount / concentration applied:
- moistened with polyethylene glycol 400 in a ratio of 500 mg of substance plus 0.9 ml of PEG 400.
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Time point:
- other: No data
- Score:
- 1
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The study was carried out in compliance with GLP according to guideline 84/449/EWG, B.4 and OECD 404. The substance is non-irritating to skin.
- Executive summary:
The substance was applied to the intact rabbit skin for 4 hours. The animals exhibited a hardly perceptible erythema 30 -60 minutes after the removal of patch. No signs of irritation at all were observed as from the 1st day p.a. During the entire test period only yellow discolouration of the skin occurred.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted in compliance with GLP standards according to Guideline 84/449/EWG, B.5 and OECD 405 (1987). However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG, B.5
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- GLP compliance:
- yes
- Species:
- rabbit
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Observation period (in vivo):
- 24, 48 an 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 ad 72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0 - 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Maximum duration: 48 h; maximum value at the end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score )
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Maximum duration: 24 h; Maximum value at the end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Maximum duration: 0 h; Maximum value at the end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Max. score:
- 1
- Remarks on result:
- other: Maximum duration: 0 h; Maximum value at the end of observation period: 0 (related to all animals)
- Other effects:
- One hour after application the conjunctiva exhibited clearly injected blood vessels up to diffusely crimson -coloured redness and swelling with the eyelids turned outwards. The iris was reddened. In addition, a yellow discharge was observed. 24 hours p.a. the conjunctival vessels of two animals were still clearly injected.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The study was carried out in compliance with GLP according to guideline 84/449/EWG, B.5 and OECD 405 (1987). The substance is non-irritating to eye.
- Executive summary:
The test substance was applied in the conjunctival sac of the rabbit eye. The substance caused mild conjunctival irritation at day 1 and 2 which was fully reversible in three days.
Reference
Application form: conjunctival sack of eye
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
In a study comparable to OECD Guideline 404 with acceptable deviations (three test site per animal, clinical signs not reported and no details of test material) three albino rabbits were exposed for 4 hour period of time under semi occlusive dressing to a patch of 1 inch x 1 inch. Substance was applied to the intact, shorn skin in the dorsal region of the rump (surface area 25 cm2). The animals exhibited a hardly perceptible erythema 30 -60 minutes after the removal of patch. No signs of irritation at all were observed as from the 1st day p.a. During the entire test period only yellow discolouration of the skin occurred. The substance was precipitated on the skin so the erythema score was given as 1. Based on the results of this study, the test material Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate is non-irritant to the skin of rabbit under test conditions. The study was conducted in compliance with GLP.
This study is classified as acceptable and satisfies the guideline requirements for the skin irritation/corrosion study. The result of this study is used as a key value for hazard assessment and classification and labeling.
Eye irritation
In a study comparable to OECD Guideline 405 with acceptable deviations (three test site per animal, clinical signs not reported and no details of test material) three albino rabbits were exposed to the substance. One hour after application the conjunctiva exhibited clearly injected blood vessels up to diffusely crimson -coloured redness and swelling with the eyelids turned outwards. The iris was reddened. In addition, a yellow discharge was observed. At 24 hours the conjunctival vessels of two animals were still clearly injected. At 72 hours no irritation of the eyes were observed. Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate is non-irritant to the eye of rabbit under test conditions. The study was conducted in compliance with GLP.
This study is classified as acceptable and satisfies the guideline requirements for the eye irritation study. The result of this study is used as a key value for hazard assessment and classification and labeling.
Justification for selection of skin irritation / corrosion endpoint:
The guideline compliant study.
Justification for selection of eye irritation endpoint:
The guideline compliant study.
Justification for classification or non-classification
Based on this data there is currently no need for classification of this substance for skin and eye irritation according to the CLP Regulation (EC) 1272/2008 and EU Directive 67/548/EEC.
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