Registration Dossier
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EC number: 255-460-7 | CAS number: 41611-76-1
- 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
- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: 28 d repeated dose study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report Date:
- 1998
Materials and methods
- Principles of method if other than guideline:
- Reinblau RLW Tr. was administered by oral gavage to male and female SD rats for 28 days at dose levels of 0, 8, 40, 200, and 1000 mg/kg to asses its toxicity and reversibility. At the end of the treatment period or an additional revovery period all animals were killed at day 29 or day 43 and necropsied; gross and microscopic examination of all major organs, including reproductive organs.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Reinblau RLW Tr. (CAS No. 41611-76-1, Lot No. 25C, Purity: 99.7%) was provided by Bayer Co., Ltd. and used in this study.
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD (SD) IGS rats (48 males and 48 females) were obtained from Charles Liver Laboratories Japan Ltd.
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: The test substance was suspended in the vehicle (0.5% CMC-Na solution)
- Details on mating procedure:
- not applicable
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily in the morning for 28 days.
- Details on study schedule:
- 6 male and 6 female rats of the control, 8, 40, 200 and 1000 mg/kg bw dose group were necropsied on day 29; additionally 6 male and 6 female rats of the control, 200, and 1000 mg/kg bw dose group were necropsied after the recovery period on day 43.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 8, 40, 200, or 1000 mg/kg
Basis:
other: nominal value
- No. of animals per sex per dose:
- control: 6 male and 6 female rats in the control, 8, 40, 200 and 1000 mg/kg bw dose group
recovery group: 6 male and 6 female rats in the control, 200, and 1000 mg/kg bw dose group - Control animals:
- yes, concurrent vehicle
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
There were no test substance-related toxic changes in organs weights of testis and ovaries. No histopathological changes were found in testis, ovaries and all other examined organs. Additional no changes were seen relating to in clinical signs, body weight, food consumption, hematology, blood chemistry and urinalysis.
Applicant's summary and conclusion
- Conclusions:
- Fertility is not affected at doses of 1000 mg/kg bw for 28 days
- Executive summary:
Reinblau RLW Tr. was administered by oral gavage to male and female SD rats for 28 days at dose levels of 0, 8, 40, 200, and 1000 mg/kg to assess its toxicity and reversibility. At the end of the treatment period or an additional revovery period all animals were killed at day 29 or day 43 and necropsied; gross and microscopic examination of: all major organs, including reproductive organs.
There were no test substance-related toxic changes in clinical sign, body weight, food consumption, hematology, blood chemistry, urinalysis, organ weight, necropsy, or histopathology.
No evidence of toxicity to reproduction was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOEL, rat: 1000 mg/kg bw/day).
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