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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-290-6 | CAS number: 1319-46-6
- 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://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Aug. 1989-Oct. 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented and corresponded to the requirements of the recommended Annex V test guidelines
- Justification for data waiving:
- other:
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tetralead trioxide sulphate
- EC Number:
- 235-380-9
- EC Name:
- Tetralead trioxide sulphate
- Cas Number:
- 12202-17-4
- Details on test material:
- - Name of test material (as cited in study report): Tribasic lead sulphate
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: Institut fur Versuchstierzzucht, A-2325 Himberg, Austria
- Age at study initiation: approx. 9 weeks at time of administration
- Weight at study initiation: See table below
- Fasting period before study: Food was withdrawn the evening before application and was offered again about 3 hours after application.
- Housing: Single caging in Makrolon cages type II (16.5 cm x 22 cm x 14 cm). Wire mesh lids. Grid floors till 7d p.a.
- Diet (e.g. ad libitum): Altomin 1314 ff, gamma irradiated with 10kGy 60 Co, ad libitum. Exception: Food was withdrawn the evening before applica tion and was offered again about 3 hours after application. Random samples of the food are analysed for contaminants by Altromin, D-4937 Lage.
- Water (e.g. ad libitum): tap water, UV-sterilised, ad libitum, offered in Makrolon bottles with stainless steel canules.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 23 degrees
- Humidity (%): average of 55%
- 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:
- other: 1% Na-Carboxymethylcellulose aqueous swelling.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The test substance was suspended in a 1% Na-Carboxymethylcellulose aqueous swelling. - Doses:
- 5000 mg/kg b.w.
- No. of animals per sex per dose:
- 5 males and 5 females
- 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 approximately 1, 10, 30 min, 1, 2, 4 and 6 hours after administration (p.a.) and then at least once a day for 2 weeks.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Changes were recorded. Body weight was determi ned before administration, 7 days p.a. and 14 days p.a. All animals were sacrificed by C02 14 days p.a. and examined macroscopically in an attempt to identify the target organs.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No animal died spontaneously during the study. The LD50 (oral) is higher than 5000 mg Austrostab 133 per kg body weight.
- Clinical signs:
- other: All animals showed raised fur and slightly decreased motor activities from about 4 hours p.a. to 9 days p.a. at the longest. Arched back was observedin animal No. 6 f between one and 4 days p.a. No other adverse effects were noted during observation time.
- Gross pathology:
- No abnormal findings were noted at post mortem examination.
Any other information on results incl. tables
This report was reviewed by the Quality Assurance Unit. The reported methods and procedures were found to describe those used and the results to constitute an accurate representation of the data recorded.
Acute oral toxicity of Austrostab 133 in rats. Limit-test. Synopsis of the results.
sex | dose (mg/kg) | number of dead/affected/exposed animals |
male | 5000 | 0/5/5 |
female | 5000 | 0/5/5 |
Acute oral Toxicity of Austrostab 133 in rats. Observations in Life
Finding | No. of the animal affected | observation time p.a. first | observation time p.a. last |
motor activities slightly decreased | 1m | 6h | 1d |
2m | 4h | 1d | |
3m | 4h | 1d | |
4m | 4h | 1d | |
5m | 4h | 1d | |
6f | 4h | 4d | |
7f | 4h | 1d | |
8f | 4h | 1d | |
9f | 4h | 1d | |
10f | 6h | 1d | |
arched back | 6f | 1d | 4d |
raised fur | 1m | 6h | 8d |
2m | 4h | 4d | |
3m | 4h | 4d | |
4m | 4h | 4d | |
5m | 1d | 1d | |
6f | 1d | 3d | |
7f | 1d | 4d | |
8f | 4h | 4d | |
9f | 6h | 4d | |
10f | 4h | 4d |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information The LD50 (oral) is higher than 5000 mg Austrostab 133 per kg body weight Criteria used for interpretation of results: other: OECD-Guideline 401
- Conclusions:
- The LD50 (oral) is higher than 5000 mg Austrostab 133 per kg body weight.
- Executive summary:
It was the aim of this study to reveal acute toxic effects of AUSTROSTAB 133 after a single oral administration of 5000 mg test substance per kg body weight. AUSTROSTAB 133 is a stabilizer.
Austrostab 133 was administered perorally to 5 male and 5 female Sprague Dawley rats once at a dose of 5000 mg test substance per kg body weight. The test substance was suspended in a 1 % Na-Carboxymethylcellulose aqueous swelling. Methods and investigations performed were in conformance with OECD-Guideline 401.
Results:
Toxic signs in life: Signs of reduced well-being in all animals were slightly decreased motor activities and raised fur. Onset of signs was approximately 4 hours p.a. No other toxic effects were noted during in life observations.
Mortality: All animals survived till the end of the study.
Post Mortem Examination:
At post mortem examination 14 days after administration no lesions were detected.
LD50 (oral):
The LD50 (oral) is higher than 5000 mg Austrostab 133 per kg body weight.
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)