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EC number: 436-690-9 | CAS number: 220727-26-4
- 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
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
Testing Proposal: OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Based on the results of the available sub-acute and sub-chronic toxicity studies performed with the test item according to GLP criteria and OECD GL 407/408 (Braun, 2001; Rashid, 2015), no adverse effects on reproductive organs and tissues such as ovaries, uterus, vagina, epididymides, prostate, vagina, seminal vesicle and testes were observed up to and including the highest dose levels tested of 750/500 mg Y-15099 /kg bw/day, respectively. Thus, no concerns in relation to reproductive toxicity were noted.
Moreover, a pre-natal developmental toxicity study via the oral route according to GLP and OECD GL 414 is available for Y-15099 (CAS 220727-26-4, Rashid, 2015). In the absence of maternal and developmental toxicity, a NOAEL = 750 mg/kg bw/day was considered for maternal and developmental toxicity.
No adverse effects on reproductive organs or tissues indicative for reproductive toxicity were observed in the available studies. However, to fulfil the data requirements a testing proposal for an Extended One-Generation Reproductive Toxicity Study (OECD 443) is included.
Effects on developmental toxicity
Description of key information
Developmental toxicity (OECD 414):NOAEL (maternal/developmental toxicity) = 750 mg/kg bw/day (rat)
Testing Proposal: Developmental toxicity (OECD 414) in a second species
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
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
Developmental toxicity of the test item was tested according to GLP criteria and OECD GL 414 (Rashid, 2015). The test item was administered by gavage to 24 females /dose groups at dose levels of 30, 150 or 750 mg/kg bw/day, respectively, during Days 5-19 of gestation. A concurrent control group of 24 pregnant female rats was included in the study. Clinical signs, body weight change, dietary intake and water consumption were monitored during the study period. On Day 20 of gestation the animals were euthanized and examined for maternal and fetal parameters. There were no adverse effects found for all parameters examined in maternal animals. Based on the number of implantations, number of total litter losses, mortality, gravid uterus weight, number of corpora lutea, placenta weight, clinical signs, body weight and gross pathology of maternal animals a NOAEL =750 mg/kg bw/day was derived for maternal toxicity. Fetal litter size and weights, offspring, viability (number alive and number dead) and sex ratio were comparable among the groups. Grossly visible abnormalities, external, head, soft tissue and skeletal abnormalities occurred incidentally in isolated fetuses of the low and high dose groups. Thus, based on the lack of adverse effects, a NOAEL = 750 mg/kg bw/day was considered for developmental toxicity.
To fulfill the data requirements a testing proposal for an OECD 414 study in a second species is included.
Justification for classification or non-classification
Based on the available data no classification is required according to CLP (1272/2008/EC).
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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