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Diss Factsheets
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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
Oral LD50 > 2000 mg/kg bw (rat; male/female)
Dermal LD50 > 2000 mg/kg bw (rat; male/female)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- 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.1 and OECD 401 (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: 82/449/EWG, B.1, OECD 401 (1987)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar Hoe: WISKf (SPF71)
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 10% suspension in Sesamol
- No. of animals per sex per dose:
- Male: 5
Female: 5 - Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw , number of animals=5 , number of deaths=0
Female: 2000 mg/kg bw , number of animals=5 , number of deaths=0 - Clinical signs:
- other: Signs of toxicity related to dose level: No signs of poisoning occurred during the entire test period. Yellow discoloured faeces were observed from the 1st to 3rd day.
- Gross pathology:
- Effects on organs: No anomalies
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was carried out in compliance with GLP according to guideline 84/449/EWG, B.1 and OECD 401. The LD50 is > 2000 mg/kg bw.
- Executive summary:
No systemic toxic effects were described after single oral application of the dose level 2000 mg/kg of the substance to rats. No signs of poisoning occurred during the entire test period. Yellow discoloured faeces were observed from the 1st to 3rd day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with GLP standards according to Guideline OECD 402. 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.3; OECD 402(1987)
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Vehicle:
- other: angeteigt mit PE-Giykol 400 im Verhaltnis 1 g Substanz + 2 ml PEG 400
- Duration of exposure:
- 24 h
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Gross pathology:
- No anomalies
- Other findings:
- Sign of toxicity (local):
No sign of poisoning occured during the entier test period. The skin of the animals was discoloured light yellow one day p.a.
Mortality did not occur - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was carried out in compliance with GLP according to guideline OECD 402. The LD50 is > 2000 mg/kg bw.
- Executive summary:
No systemic toxic effects were described after single oral application at the dose level 2000 mg/kg in rats. No signs of poisoning occurred during the entire test period. The skin of the animals was coloured light yellow for one day after administration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral exposure
In a guideline study (82/449/EWG, B.1, OECD 401 (1987) with acceptable restrictions (no purity of test material given) 5 male and 5 female rats were gavaged with test substance (calcium 4 -chloro-2 -(5 -hydroxy-3 -methyl-1-(3- sulfonatophenyl)pyrazol-4 -ylazo)-5 - ethylbenzenesulfonate).
The test substance was administered in 10% Sesamol suspension at concentration of 2000 mg/kg bw. The post exposure period was 14 days. The estimated oral LD50 value for male and female animals is > 2000 mg/kg bw. During the study no mortality or no signs of toxicity was observed.
The study of was selected as a key study and the result is used as a key value for hazard assessment and classification and labeling.
Justification for selection of acute toxicity – oral endpoint
The guideline compliant study.
Justification for selection of acute toxicity – inhalation endpoint
Toxicity unlikely based on oral and dermal study results. Not likely exposure route, since RMMs measures are in use.
Justification for selection of acute toxicity – dermal endpoint
The guideline compliant study.
Justification for classification or non-classification
Based on the results of acute toxicity studies no classification is proposed for acute toxicity according to the criteria of CLP regulation 1272/2008 and the EU directive 67/548/EEC.
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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