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EC number: 915-600-6 | CAS number: 64553-79-3
- 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 approach used to analogue substance. Assumption that target substance will have the same properties. Available data for the source substance Solvent Blue 98:
Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, oral (gavage), rat , M/F, OECD guideline 422, GLP
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:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX - Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects on reproductive parameters
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Based on read across to an analogue substance, The value of NOAEL (No Observed Adverse Effect Level) for reproduction and development for Solvent Blue 79 was predicted to be 1000mg/kg body weight per day. This was the highest dose given in an OECD 422 study conducted on the analogue source substance Solvent Blue 98. There were no treatment related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival of offspring. The Target subtance Solvent Blue 79 is expected to have the same properties as the tested analogue substance Solvent Blue 98.
- Executive summary:
A read across approach was used to evaluate potential reproductive toxicity effects of Solvent Blue 79 following repeated oral exposure ( Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-(butylamino)-4-[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-[(2-ethylhexyl)amino]-4-(methylamino)-9,10-dihydroanthracene-9,10-dione).
An analogue substance Solvent Blue 98 was tested according to OECD guideline 422. The analogue substance is compositionally very similar. It is also anthraquinone based, with aliphatic amine substitutions. Where the Solvent Blue 79 contains ethylhexyl amine groups, methyl amine groups and butylamine groups, the Solvent Blue 98 contains ethylhexyl amine, methyl amine and pentyl amine groups. There is therefore overlap in the compositions and the structures are very similar. Further supporting information on the readacross approach has been provided in section 13 (Read across justification document).
Based on read across to an analogue substance, Solvent Blue 79 is not expected to cause any treatment related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival of offspring.
The analogue substance results relevent to reproductive toxicity are summarised below:
There were no treatment-related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival of offspring in any treated groups compared to controls.
Limited gross pathological observations on postpartum day 4 pups revealed blue adipose tissue and stomach contents in pups from all treated groups. This discoloration was attributed to the dye nature of the test material and demonstrated systemic exposure to the pups via the milk.The NOEL for reproductive toxicity or for effects on prenatal/neonatal growth and survival was 1000 mg/kg/day, the highest dose level tested.
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
- Quality of whole database:
- good
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In an OECD 422 study on the read across analogue substance Solvent Blue 98, there were no treatment related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival. Based on similarity in composition and structure, Solvent Blue 79 would be expected to produce similar results. The NOEL for reproductive toxicity was 1000mg/kg bw.
Therefore the criteria for classification are not met.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.