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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 429-280-6 | CAS number: 151900-44-6
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity
Non-human information
Repeated dose toxicity: oral
In a subacute toxicity study the test substance Vulcuren (purity: 99.7%) was administered orally via gavage to male and female Wistar rats at target concentrations of 0, 40, 200 and 1000 mg/kg body weight for about 4 weeks (Bayer AG 2000d). In parallel male and female rats (5 per sex and group) were treated with 0 and 1000 mg/kg body weight. These rats were observed for reversibility, continuance or delay occurrence of toxic effects during a recovery period of about 2 weeks. No differences regarding the survival rat or general behaviour were noted compared to the untreated animals. In addition, no relevant differences were observed in mean feed intake and weight gain in any of the treatment groups evaluated compared to the negative control. No neuronal behaviour effects were noted in any of the treatment groups. There were no toxicologically relevant changes in haematology and clinical chemistry in animals treated with the test compound. No biologically relevant effects on the organ weights were found in any of the rats treated with the test substance compared to the control animals. In addition, there was no evidence of any gross pathological and histopathological findings associated to dosing with the test compound up to the highest dose group (1000 mg/kg body weight) in both genders.
The author concluded that the administration of Vulcuren (purity: 99.7%) to male and female Wistar rats for about 4 weeks was tolerated without adverse effects up to and including 1000 mg/kg. No delayed occurrence of toxic effects was observed during a recovery period of about 2 weeks (Bayer AG 2000d).
Repeated dose toxicity: inhalation
There are no data available.
Repeated dose toxicity: dermal
There are no data available.
Repeated dose toxicity: other routes
There are no data available.
Human information
There are no data available.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD Guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: 96/54/EG, B.7 (1996); OECD 407 (1995)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: 5 to 6 weeks
- Fasting period before study:
- Housing:animals were housedindividually in type II A-cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 5%
- Air changes (per hr): 15 to 20 changes per hour
- Photoperiod: 12hrs dark / 12hrs light)
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Method of administration:
Schlundsonde
the test substance was administered by gavage from the start of the study until day 27 for the recovery groups and until the day before scheduled sacrifice for the main group. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- during the study period, the test substance content in the vehicle was checked two times, determination of the test substance solved in corn oil was done by HPLC, homogeneity tested prior study and during study
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- Remarks:
- Doses / Concentrations:
0, 40, 200, 1000 mg/kg bw
Basis: - No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 40 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 40 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Main group: 0, 40, 200, 1000 mg/kg, 5 animals/dose/sex
Recovery group (14 d recovery period): 0, 1000 mg/kg 5 animals/dose group - Positive control:
- none
- Observations and examinations performed and frequency:
- Inspection for morbidity, mortality and general clinical examinations: once a day; body surfaces and orifices, posture, general behavior, breathing and excretory products were assessed
Body weight determination: before the beginning of the study and weekly during the study, feed intake: once per week; - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Hematological investigations, clinical chemistry, neurotoxicity tests (functional observation battery, motor activity)
- Statistics:
- Dunnett test, p value adjusted Welch test, Kruskal-Wallis test, Mann-Whitney.Wilcoxon test (U tests)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- HAEMATOLOGY: The examination of the red blood cells, thrombocyte counts and prothrombin time showed no toxicologically relevant changes. A statistically significant decrease in erythrocyte counts was seen in high-dose males of the main group treated with the test substance. Hematocrit was unaffected in that group leading to a corresponding increase in mean corpusular volume of single erythrocyte. These changes were only slight and ranged within the 2s limits of historical controls. Furthermore the mean of the concurrent control group was somewhat above the mean male historical controls. No effects were observed in the other sex. Therefore, these changes are considered to be incidental findings of no biologic significance and are unrelated to treatment.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Critical effects observed:
- not specified
- Executive summary:
In a subacute toxicity study the test substance Vulcuren Trial Product KA 9188 was administered orally via gavage to male and female Wistar rats at target concentrations of 0, 40, 200 and 1000 mg/kg body weight for about 4 weeks. In parallel male and female rats (5 per sex and group) were treated with 0 and 1000 mg/kg body weight. These rats were observed for reversibility, continuance or delay occurrence of toxic effects during a recovery period of about 2 weeks. No differences regarding the survival rat or general behaviour were noted compared to the untreated animals. In addition, no relevant differences were observed in mean feed intake and weight gain in any of the treatment groups evaluated compared to the negative control. No neuronal behavior effects were noted in any of the treatment groups. There were no toxicologically relevant changes in haematology and clinical chemistry in animals treated with the test compound. No biologically relevant effects on the organ weights were found in any of the rats treated with the test substance compared to the control animals. In addition, there was no evidence of any gross pathological and histopathological findings associated to dosing with the test compound up to the highest dose group (1000 mg/kg body weight) in both genders. The author concluded that the administration of Vulcuren Trial Product KA 9188 to male and female Wistar rats for about 4 weeks was tolerated without adverse effects up to and including 1000 mg/kg. No delayed occurrence of toxic effects was observed during a recovery period of about 2 weeks (Bayer AG 2000d).
Reference
Clinical observations: No mortality occurred during the study period.
There were no changes in clinical appearance, functional observations, body weights, and food consumption
The functional observations showed no signs or symptoms indicating evidence for systemic toxic and neurotoxic potential. Grip strength and motor activity measurements exhibited no treatment-related changes in both sexes at doses of 1000 mg/kg bw/d and below.
Laboratory findings: There were no biological significant effects of treatment on hematological and biochemical parameters. For a small number of parameters the differences between control and test groups attained a degree of statistical significance. However, the differences were small, not dose-related and inconsistent between the sexes.
Effects in organs: There were no treatment-related findings in organ weights, gross or microscopic pathology in rats of both sexes given 1000 mg/kg bw/d and below. Histopathological changes seen were of a minor nature and at a similar level to those seen in the controls.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP and OECD Guideline study
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The findings of the subacute toxicity study revealed, that administration of Vulcuren (purity: 99.7%) to male and female Wistar rats was tolerated without effects up to and including 1000 mg/kg body weight. In addition, no delayed occurrence of toxic effects was observed during a recovery period of about 2 weeks. Therefore, 1000 mg/kg body weight and day is assumed to be the No Adverse Effect Level (NOAEL) and was used for the DNEL calculation.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
key study is used (only available study)
Justification for classification or non-classification
Classification is not required based on the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)