Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 275-602-1 | CAS number: 71550-21-5
- 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
In an OECD 421 study (OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)) three groups of ten male and ten female CD rats received Bayscript Yellow GGN at doses of 10, 30 or 70 mg/kg/day by oral gavage administration. Males were treated daily for two weeks before pairing, up to necropsy after a minimum of four consecutive weeks. Females were treated daily for two weeks before pairing, throughout pairing, gestation and until Day 12 of lactation. Females were allowed to litter, rear their offspring and were killed on Day 13 of lactation. The F1 generation received no direct administration of the test item; any exposure was in utero or via the milk.
During the study, for adult animals assessments of clinical condition, body weight, food consumption, estrous cycles, pre-coital interval, mating performance, fertility, gestation length, organ weight and macroscopic pathology and histopathology investigations were undertaken.
For the offspring, clinical condition, litter size and survival, sex ratio, body weight, ano‑genital distance and nipple counts (males only), and macropathology were also assessed. Blood samples were collected from all adult animals at termination and from selected offspring on Day 4 and Day 13 of age for thyroid hormone analysis.
The oral administration of Bayscript Yellow GGN up to and including 70 mg/kg/day for four weeks in males and for two weeks prior to pairing, throughout gestation and up to Day 13 of lactation in females, was generally well tolerated. Clear adverse reductions in body weight performance and food consumption were evident in the parental animals given 70 mg/kg/day throughout the study, although in the absence of any change in general clinical condition. Test item-related histopathological changes were evident in the kidneys, manifest as an increase in both incidence and severity of tubular collecting duct basophilia, tubular dilatation and intratubular crystals in the kidneys of animals receiving 30 or 70 mg/kg/day, associated with increases in kidney weights in both sexes and with gross changes of pale and granular kidneys seen at necropsy; these kidney changes were considered to be adverse. It was therefore concluded that within the context of this study, the No Observed Adverse Effect Level for systemic toxicity was 10 mg/kg/day.
There was no evidence of any adverse effects on mating performance or fertility of the adult animals or on the survival or development of the F1 offspring. The reduction in the number of uterine implantations at 70 mg/kg/day (and as a consequence litter size) was not related to any other changes in reproductive parameters, such as post implantation loss. This effect, however, was statistically significant and outside of the historical control values (representing 22 OECD TG 421 and 422 studies). Although this effect is considered likely to be secondary to the lower maternal body weight at the time of mating, it is considered to be of uncertain aetiology and therefore potentially adverse. It was therefore concluded that within the context of this study, the NOAEL for reproductive performance was 30 mg/kg/day.
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP guideline study
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
Toxicity to reproduction: other studies
Description of key information
No data.
Justification for classification or non-classification
In an OECD 421 study (OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)) there was no evidence of any adverse effects on mating performance or fertility of the adult animals or on the survival or development of the F1 offspring. The reduction in the number of uterine implantations at 70 mg/kg/day (and as a consequence litter size) was not related to any other changes in reproductive parameters, such as post implantation loss. This effect, however, was statistically significant and outside of the historical control values (representing 22 OECD TG 421 and 422 studies). Although this effect is considered likely to be secondary to the lower maternal body weight at the time of mating, it is considered to be of uncertain aetiology and therefore potentially adverse. It was therefore concluded that within the context of this study, the NOAEL for reproductive performance was 30 mg/kg/day. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
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.