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EC number: 700-714-9 | CAS number: 1254469-57-2
- 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
Based on the results of a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test of TINOCAT ES 96000 in rats by oral gavage, the changes noted for females at the highest dose level were considered to be treatment related but not adverse. Therefore, a NOAEL of 800 mg/kg bw/day was derived.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
A GLP compliant Combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to guideline OECD 422 (WIL Research Europe B.V. 2013). After acclimatization, four groups of ten male and ten female Wistar Han rats were exposed daily by oral gavage to the test substance,Tinocat ES 96000, at 0, 80, 250 and 800 mg/kg bw/day (dose level selection based on the results of a 14-day dose range finding study). Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 43- 54 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation. Formulation analysis showed that the formulations were prepared accurately, were homogenous, and were stable for at least 5 hours at room temperature. Females at 800 mg/kg bw/day had higher absolute and relative spleen weights. Microscopic alterations associated with treatment were present in the spleen and sternal bone marrow of females. These were characterized by an increased severity of primarily erythroid hemopoeitic foci in the spleen of treated animals and a parallel increase in the incidence of minimal erythroid hyperplasia in the bone marrow. However, this alteration may have reflected a slightly increased erythrocyte turnover in treated animals, which remained within physiological limits. Taken together, the changes noted for females at 800 mg/kg bw/day were considered to be treatment related but not adverse.In conclusion, treatment with Tinocat ES 96000 by oral gavage in male and female Wistar Han rats at dose levels of 80, 250 and 800 mg/kg bw/day revealed no toxicity up to 800 mg/kg bw/day. Based on these results, a No Observed Adverse Effect Level (NOAEL) of 800 mg/kg bw/day was derived.
Range-finder
A 14-Day dose range finding study for a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test of Tinocat ES 96000 was conducted in rats by oral gavage.
Guidelines
No guidelines are applicable as this pilot study was used to select dose levels for the Combined 28-day Repeated Dose Toxicity Study with the Developmental/Repro Screening Test of Tinocat ES 96000 (Project 501296; BASF Project 85R0013/11X545).
Rationale for dose levels
After single oral administration of Tinocat ES 96000 three out of 6 rats died at 2000 mg/kg bw/day. No animals died at 300 mg/kg bw/day. The dose levels for this 14-day toxicity study were selected to be 0, 300 and 800 mg/kg bw/day.
Study outline
After acclimatization, three groups of four male and four female Wistar Han rats were exposed by oral gavage to the test substance at 300 (Group 2) or 800 mg/kg bw/day (Group 3) for 14 days. Rats of the control group (Group 1) received the vehicle, 1% Aqueous carboxymethyl cellulose, alone.
Evaluated parameters
The following parameters were evaluated: mortality / viability, clinical signs, body weights, food consumption, clinical laboratory investigations (haematology, clinical biochemistry), macroscopy and organ weights. Chemical analyses of formulations were conducted once during the study to assess accuracy, homogeneity and stability.
Results/discussion
Formulation analysis showed that the formulations were prepared accurately and homogenously, and were stable when stored at room temperature under normal laboratory light conditions for at least 5 hours.
Results:
Effects related to treatment with Tinocat ES 96000 included lower body weight gain with decreased food intake at 800 mg/kg bw/day, and to a lesser extent also at 300 mg/kg bw/day. A slight increase in aspartate aminotransferase was seen in males at 800 mg/kg bw/day, as well as slightly lower liver weights. No changes were noted in clinical appearance, haematology investigations and macroscopic examination up to a dose of 800 mg/kg bw/day. Based on the results of this dose range finding study, dose levels of 0, 80, 250 and 800 mg/kg bw/day were selected for the main study (Project 501296; BASF Project 85R0013/11X545), taking into account the longer administration period and inclusion of pregnant animals. Due to the absence of clinical signs after dosing in the present study, clinical observations and functional observational tests were conducted directly after dosing in the main study.
Justification for classification or non-classification
Based on the available data, the test substance is not classified with regard to repeated dose toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.
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