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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
- 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
Repeated dose toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- 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:
- guideline study
- Remarks:
- well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, company breeding colony
- Age at study initiation: ca. 6 weeks
- Weight at study initiation:
-- control male: 124 +/- 2 g
-- control female: 130 +/- 5 g
-- low dose male: 124 +/- 8 g
-- low dose female: 131 +/- 9 g
-- mid dose male: 128 +/- 7 g
-- mid dose female: 133 +/- 5 g
-- high dose male: 128 +/- 5 g
-- high dose female: 133 +/- 5 g
- Fasting period before study: none
- Housing: Makrolon(R) cages, groups of five animals of the same sex, air-conditioned
- Diet (e.g. ad libitum): rat diet Altromin 1324(R), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: daily, immediately before application
VEHICLE
- Concentration in vehicle: 0.00 / 0.63 / 2.50 / 10.00 % (w/v)
- Amount of vehicle (if gavage): Applied Volume = 10 ml/kg bw - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 28 applications within 29 days, one application per day, 7 times a week
- Frequency of treatment:
- once a day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Doses / Concentrations:
0.0 mg/kg bw
Basis:
actual ingested
- Dose / conc.:
- 62.5 mg/kg bw/day (actual dose received)
- Remarks:
- Doses / Concentrations:
62.5 mg/kg bw
Basis:
actual ingested
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Remarks:
- Doses / Concentrations:
250.0 mg/kg bw
Basis:
actual ingested
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- Doses / Concentrations:
1000.0 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes (absolute and relative)
WATER CONSUMPTION): Yes
OPHTHALMOSCOPIC EXAMINATION: Yes (macroscopic examination and opacity)
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
URINALYSIS: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
ORGAN WEIGHT: Yes - Statistics:
- Statistics applied for differences (p=0.05) betweeen control and dose groups for: Body weight, body weight gain, hematology parameters, clinical parameters, albumin, globulin, organ weight (absolute and relative), pH and specific weight of urine
Results and discussion
Results of examinations
- 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:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- based on examination of macroscopic effects and opacity
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Female, 1000 mg/kg bw group: statistically increased Alpha1-Globulin, decreased Alpha3- and Beta1-Globulin but within the range of historical controls. Decreased inorganic phosphate.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Male and female, 1000 mg/kg bw group: decreased specific urine weight
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed at 1000 mg/kg bw, the highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the findings in this oral 28-day repeated dose toxicity study the NOAEL was determined to be >= 1000 mg/kg bw, which was the highest dose tested.
- Executive summary:
The test item was tested for subacute oral toxicity according to OECD guideline 407. Following this protocol male and female Wistar rats were treated once daily by oral gavage with 0.00, 62.50, 250.00, or 1000.00 mg/kg bw (28 applications).
Behavior and health condition were observed twice daily and once a day at weekends and at public holidays. Body weight and food consumption were determined twice a week and water consumption once a week. At the end of the study hematology, clinical chemistry and urine parameters were collected. At necropsy macroscopic investigations were performed, organ weights were determined, and relative organ weights were calculated. Heart, lung, liver, kidney, spleen, stomach, jejunum, colon, thymus, testes, adrenal gland, and bone marrow were subject of histopathological examinations.
Behavior, health condition, food and water consumption, and body weight gain were not affected by the treatment. Hematological examinations revealed no signs of toxicity. From the clinical chemistry parameters phosphate was decreased, alpha1-globulin was increased and alpha3- and beta1-globulin were decreased in females of the high dose group. Except the specific urine weight which was decreased in males and females of the high dose group no other urine parameters were affected by the treatment.
Necropsy revealed no macroscopic or microscopic abnormalities that could be attributed to the treatment. Organ weights of the dose groups showed no treatment related differences as compared to the control groups.
In conclusion it can be stated that doses up to 250 mg/kg bw didn't cause any signs of toxicity. Although single urine and clinical parameters showed differences between the control and the 1000 mg/kg bw groups, the values were still within the range which is typical for rats of this strain. Moreover there are neither signs of morphological and functional impairments nor any other indications for adverse effects caused by the test item. Therefore the findings were considered to be accidental and/or of no toxicological relevance.
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.
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