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EC number: 265-634-4 | CAS number: 65212-77-3
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Read-across: Equivalent to OECD 421; GLP; male/female Wistar rats; oral (gavage); 160, 400, and 1000 mg/kg bw/day; 28 – approx. 56 days; daily administration; no adverse effects observed; NOAEL male/female 1000 mg/kg bw/day
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- other: read-across
- Sex:
- male/female
- Basis for effect level:
- other: no effects assumed
- Critical effects observed:
- no
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- other: read-across
- Sex:
- male/female
- Basis for effect level:
- other: no effects assumed
- Critical effects observed:
- no
- Reproductive effects observed:
- no
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Read across justification
The test item was not analyzed for its potential to influence reproduction and development. Experimental data of a structural analogue are available. Both substances are calcium salts of sulphonatophenyl-pyrazol-azobenzenesulfonic acid of low solubility in water and octanol. In addition, both substances have a molecular weight higher than 500 g/mol which decreases gastro intestinal absorption and systemic bioavailability (a detailed read across justification is given in CSR, Annex I).
Procedure and observations
A Reproduction / Developmental Toxicity screen was conducted to determine possible influence on fertility and teratogenicity. The analogue substance was administered by gavage at concentrations of 0,160, 400 and 1000 mg/kg bw/day to male and female Wistar rats (12/sex/dose). Males were treated totally for 28d, females were treated until 3rd day of lactation.
The test material did not influence fertility or reproduction of the test animals. Atrophic changes in prostate gland of parental males of the high dose group were observed. This effect did not negatively influence fertility of parental males.
Discussion
Administration of an analogue test substance up to 1000 mg/kg bw did not induce mortalities, clinical signs or changes in body weight or food consumption. Mating behavior, fertility, gestation and lactation were not influenced by the test item. A decrease of the absolute and relative weight of the prostate gland was recorded in males of all dose levels (dose-independent). The histological examination demonstrated the increased occurrence of atrophic changes in prostate gland of males at the dose level 1000 mg/kg/day (without negative influence on fertility of parental males). Yellow-colored feces of males and females at dose levels 400 and 1000 mg/kg bw/day, discolored cecum and stomach in males and yellow-colored intestine and stomach contents without changes of structure of these organs were reported during pathological examinations of males and females at 1000 mg/kg bw/day and 400 and 1000 mg/kg bw/day, respectively. Therefore, the test material is not considered to be toxic to reproduction or the developing offspring. Thus, the NOAEL for reproduction and development was 1000 mg/kg bw/day for both parental animals and offspring. The NOAEL for general toxicity, based on atrophic changes in the prostate, was considered to be 400 mg/kg bw/day.
Short description of key information:
Experimental data of a read across substance (methylated calcium
salt) are used to evaluate the reprotoxic potential of the test item. A
screening assay was conducted to determine toxicity to reproduction and
development (OECD guideline 421, GLP). The structural analogue did not
influence fertility of parental animals or development of the offspring.
The NOAEL for fertility was considered to be 1000 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
Read-across: Equivalent to OECD 421; GLP; male/female Wistar rats; oral (gavage); 160, 400, and 1000 mg/kg bw/day; 28 – approx. 56 days; daily administration; no adverse effects observed; NOAEL offspring 1000 mg/kg bw/day
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- other: read-across
- Basis for effect level:
- other: no effects assumed
- Abnormalities:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- other: read-across
- Sex:
- male/female
- Basis for effect level:
- other: no effects assumed
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Read across justification
The test item was not analyzed for its potential to influence reproduction and development. Experimental data of a structural analogue are available. Both substances are calcium salts of sulphonatophenyl-pyrazol-azobenzenesulfonic acid of low solubility in water and octanol. In addition, both substances have a molecular weight higher than 500 g/mol which decreases gastro intestinal absorption and systemic bioavailability (full read across justification in CSR, Annex I).
Procedure and observations
A Reproduction / Developmental Toxicity screen was conducted to determine possible influence on fertility and teratogenicity. The test item was administered by gavage at concentrations of 0,160, 400 and 1000 mg/kg bw/day to male and female Wistar rats (12/sex/dose). Males were treated totally for 28d, females were treated until 3rd day of lactation. As a result, the ability of male and female animals to successfully mate and produce viable offspring was unaffected by the test substance treatment. Also development of pups was not changed in treatment groups.
Discussion
Administration of the analogue substance did not affect number, viability and development of the offsping, also teratogenicity was not observed. Thus, the substance is not considered to own developmental toxicity
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Commission Regulation (EU) 2018/1480 of Oct 4, 2018.
Additional information
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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