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Diss Factsheets
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EC number: - | CAS number: -
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April-June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed according to OECD 421 and GLP principles.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 421
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA OPPTS 870.3550
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- B508
- IUPAC Name:
- B508
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material : B508
- Physical state: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 11 wks
- Weight at study initiation: 295-320 g for males; 182-208 g for females
- Housing: in Macrolon cages with sterilized sawdust as bedding material and paper as cage-enrichment; 5 animals/sex/cage pre-mating; 1 male and 1 female per cage during mating; at post-mating males were kept with a maximum of 5 animals/cage and females were individually housed.
- Diet: free access to pelleted rodent diet
- Water: free access to tap-water
- Acclimation period: at least 5 days prior to start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-21.4
- Humidity (%): 33-76
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 29 April - 17 June 2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 w/v% methylcellulose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: prepared daily within 6 hours prior to dosing and homogenized to a visually acceptable level
VEHICLE
- Justification for use and choice of vehicle (if other than water): based on information provided by the sponsor and trial formulations at the test lab.
- Amount of vehicle (if gavage): 5 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations analysed at 50 and1000 mg/kg bw/d, based on copper and strontium analysis using ICP-MS, were in agreement with the target concentrations (i.e. mean accuracies between 85 and 115%). The concentrations analysed at 250 mg/kg bw/d, based on copper analysis, were slightly above target concentration (mean accuracy 116%) but the result was accepted since the corresponding result based on strontium analysis was well within the criterion range.
- Details on mating procedure:
- - M/F ratio per cage: 1/1 (one female was cohabitated with one male of the same treatment group, avoiding sibling mating)
- Length of cohabitation: maximum 14 days with one male
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy
- Further matings after an unsuccessful attempt: no - Duration of treatment / exposure:
- Males were exposed for 28 days, i.e. 2 weeks prior to mating, during mating, and up to the day prior to necropsy. Females were exposed for 40 to 49 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 3 days of lactation.
- Frequency of treatment:
- Once daily for 7 days per week. Animals were dosed up to the day prior to scheduled necropsy.
- Duration of test:
- Pups were killed on day 4 of lactation or shortly thereafter.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 250 and 1000 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 9 litters/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: the selected dose levels are based on the outcome of the 28-day repeated dose study (CERI B11-0899; see 7.5.1). The NOAEL of this study was 1000 mg/kg bw/d based on the absence of effects.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once daily
BODY WEIGHT: Yes
- Time schedule for examinations: Males and females were weighed on the first day of exposure and weekly thereafter. Mated females were weighed on Days 0, 4, 7, 11, 14, 17 and 20 post-coitum, and during lactation on Days 1 and 4.
FOOD CONSUMPTION: Yes
Weekly, for males and females. Food consumption was not recorded during the breeding period. Food consumption of mated females was measured on day 0, 4, 7, 11, 14, 17 and 20 post-coitum and during lactation on day 1 and 4.
WATER CONSUMPTION : No
Subjective appraisal was maintained during the study, but no quantitative investigation was introduced as no effect was suspected. - Ovaries and uterine content:
- not examined
- Fetal examinations:
- yes, foetal weight
- Statistics:
- The following statistical methods were used to analyze the data:
- If the variables could be assumed to follow a normal distribution, the Dunnett-test (Dunnett, 1955) (many-to-one t-test) based on a pooled variance estimate was applied for the comparison of the treated groups and the control groups for each sex.
- The Steel-test (Miller, 1981) (many-to-one rank test) was applied if the data could not be assumed to follow a normal distribution.
- The Fisher Exact-test (Fisher 1950) was applied to frequency data.
- The implantation index, number of live pups born, sex ratio and delivery index were subjected to the Kruskal-Wallis nonparametric ANOVA test (Kruskal, 1952) to determine intergroup difference. If the results of the ANOVA were significant (p<0.05), the Wilcoxon test (Wilcoxon, 1945) was applied to the data to compare the treated groups to the control group.
All tests were two-sided and in all cases p < 0.05 was accepted as the lowest level of significance.
Group means were calculated for continuous data and medians were calculated for discrete data (scores) in the summary tables. Test statistics were calculated on the basis of exact values for means and pooled variances. Individual values, means and standard deviations may be rounded off before printing. Therefore, two groups may display the same printed means for a given parameter, yet display different test statistics values.
No statistical analysis was performed on histopathology findings.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
There was no treatment-related change in postnatal loss, viability index, clinical symptoms, sex ratio, pup weight or external appearance at necropsy.
Applicant's summary and conclusion
- Conclusions:
- In a screening reproduction/developmental toxicity study in rats the NOAEL for developmental toxicity was established as being at least 1000 mg/kg bw/d.
- Executive summary:
Rats were dosed with 0, 50, 250 or 1000 mg/kg bw/d B508 via gavage in a screening reproduction/developmental toxicity study performed according to OECD 421 and GLP principles.
There was no treatment-related change in postnatal loss, viability index, clinical symptoms, sex ratio, pup weight or external appearance at necropsy. Therefore, the NOAEL for developmental toxicity was established to be at least 1000 mg/kg bw/d.
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