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EC number: 931-722-2 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sept. 1991-Feb. 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. Rationale for key study selection: the substance “Reaction product of lead chloride or lead sulphate with alkaline solution” consist mainly of Lead carbonate, which has been studied in this robust study summary. Well-documented and corresponded to the requirements of the recommended Annex V test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Trilead bis(carbonate) dihydroxide
- EC Number:
- 215-290-6
- EC Name:
- Trilead bis(carbonate) dihydroxide
- Cas Number:
- 1319-46-6
- Molecular formula:
- C2H2O8Pb3
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Basic Lead Carbonate
- Physical state: white powder
- Analytical purity: Technical grade (min. 99%)
- Impurities (identity and concentrations): traces of lead acetate (<0.3%) and stearic acid- Composition of test material, percentage of components: Lead Content: approx. 79.5%
- Stability under test conditions: stable at room temperature- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Forschungsinstitut fur Versuchstierzucht, A-2325 Himberg
- Age at study initiation: approx. 8 weeks at time of administration
- Weight at study initiation: See Table
- Fasting period before study: Feed was withdrawn the evening before application and was offered again about three hours after application.
- Housing: Single gaging in Makrolon cages type III (39 cm x 23 cm x 15 cm). Wire mesh lids. Bedding material: for laboratory animals, type 4 HV (Finn Tapvei Ky, SF-73600 Kaavi), gamma irradiated with 10 kGy 60Co.
- Diet (e.g. ad libitum): Altromin 1314 ff, gamma irradiated with 10 kGy 60Co, ad libitum. Random samples of the feed are analysed for contaminants by Altromin, D-4937
- Water (e.g. ad libitum): tap water,offered in Makrolon bottles with stainless steel canules, ad libitum.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22 degrees centigrade
- Humidity (%): average of 70%
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): artificial light from 6AM to 6 PM
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED: 10 ml per kg body weight
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- "NAFTOVIN T2" was administered once perorally to 5 male and 5 female Him:OFA rats. The test substance, suspended in Arachis oil, was applied once at a dose of 2000 mg per kg body weight by stomach intubation.
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Behavior, reactions and physical signs of the animals were observed 10, 30 min, 1, 2, 4 and 6 hours after administration (p.a.) and then at least once a day for a total of 2 weeks. Body weight was determined before administration, 7 days p.a. and 14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived until the end of the study.
- Clinical signs:
- All animals were normal during the whole study. No toxic signs were noted.
- Body weight:
- Body weight gain of the animals was inconspicuous.
- Gross pathology:
- 9/10 animals were normal at post mortem examination. In one male, white foci on the surface of the liver, large mesenterial lymph nodes and a large caecum were noted.
- Other findings:
- No sex differences between males and females were noted in the response to the test substance.
Any other information on results incl. tables
Synopsis of Results:
sex | dose (mg/kg) | number of dead/affected/exposed animals |
male | 2000 | 0/0/5 |
female | 2000 | 0/0/5 |
Post mortem Findings:
System organ, finding | sex | No. of affected animal |
Normal | m | 11, 12, 13,14 |
f | 16,17,18,19,20 | |
Alimentary System | ||
Liver, White foci, >5, 1 mm diameter | m | 15 |
Caecum, large | m | 15 |
Haematopoietic System | m | 15 |
Lymph nodes, mesenterial, large | m | 15 |
Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.
See IUCLID Section 13 for Analogue approach report.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The observations in life revealed no toxic signs. 9/10 animals were normal at post mortem examination. Alterations of the 10th rat are not attributed to the action of the test substance, as similar changes are known to occur spontaneously with a low incidence in untreated rats of the strain used, and due to the single occurence in this study.
No differences between the sexes were noted in the response to the test substance.
All animals survived until termination.
Therefore, LD50 (oral) for both male and female rats is higher than 2000 mg "NAFTOVIN T2" per kg body weight. - Executive summary:
It was the aim of this study to reveal acute toxic effects of "NAFTOVIN T2" after a single oral administration. The study was conducted considering OECD Guideline 401 (Limit-Test).
"NAFTOVIN T2" was administered once perorally to 5 male amd female Him:OFA rats. The test substance, suspended in Arachis oil, was applied once at a dose of 2000 mg per kg body weight by stomach intubation.
Results:
Mortality: All animals survived until 14 days p.a.
Observations in life: All animals were normal during the whole study. No toxic signs were observed.
Body Weight: Body weight gain was inconspicuous in all animals.
Post mortem findings: 9/10 animals were normal at terminal necropsy. Different alterations, observed in one male, are not regarded as test substance related.
Sex differences: No differences between the sexes were observed in the response to the test substance.
Due to the results obtained in this study LD50 (oral) of "NAFTOVIN T2" is beyond 2000 mg per kg body weight in both female and male rats. No toxic effects of the test substance were noted.
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