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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26. April - 23. July 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- - Residual solvent:
43.1 % w/w
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6-08697-43
- Expiration date of the lot/batch: 27.09.2022
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (20 ± 5 °C)
- Stability under test conditions: not stated
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 228 - 239 g
- Fasting period before study: no
- Housing: 1-3 animals per cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving.
The required amount of undiluted test item (according to the body weight and dose and corrected by factor 1.757) was applied directly on the shaved skin of the back uniformly on an area approximately 10 % of a total body surface area. The test item was held in contact with the skin by using semiocclusive dressing with non-irritating tape throughout the 24-hours exposure period. At the end of the exposure period, any residuals of the test item were removed by using lukewarm water. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Animals were observed individually immediately after the application of the test item and then 0.5,
1, 2, 4 and 6 hours later. Each animal was inspected daily for the next 14 days.
Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory,
circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern.
Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep
and coma. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of the test
item using the Draize criteria - Statistics:
- none
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- no mortalitity occured
- Clinical signs:
- other: no signs of intoxication, change of health, nor any adverse reactions during 14-days observation period
- Gross pathology:
- All animals were necropsied. During necropsy, no macroscopic changes were noticed.
- Other findings:
- The test item did not cause any changes on the skin of the test animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item Reaction mass of potassium sodium phosphotartrate and potassium sodium
tartrate and potassium sodium ortho-phosphate (aqueous solution) is greater than 2000 mg/kg body
weight after single dermal application to Wistar rats. - Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item Reaction mass of
potassium sodium phosphotartrate and potassium sodium tartrate and potassium sodium orthophosphate (aqueous solution) when applied as a single dermal dose to Wistar rats. The procedure
according to OECD Test Guideline 402 Acute Dermal Toxicity: Fixed Dose Procedure was used.
Test item information were available, a limit dose of 2000 mg/kg body weight was used as starting
dose. One female was dosed. Test item-related mortality was not observed during 48 hours. Based on
the outcome in the dose-range finding study, the main study was conducted with 2 further animals to
confirm the classification outcome. A total of three female rats were dosed with a limit dose of 2000
mg/kg body weight.
The test item Reaction mass of potassium sodium phosphotartrate and potassium sodium tartrate and
potassium sodium ortho-phosphate (aqueous solution) applied to 3 females at a limit dose of 2000
mg/kg body weight did not cause death. Mildly increase of the body weight of animals was observed.
No signs of intoxication, change of health, nor any other adverse reactions during 14-days observation
period was observed. The test item did not cause any changes on the skin of the test animals. During
necropsy, no macroscopic findings were observed.
The LD50of the test item Reaction mass of potassium sodium phosphotartrate and potassium sodium
tartrate and potassium sodium ortho-phosphate (aqueous solution) is greater than 2000 mg/kg body
weight after single dermal application to Wistar rats.
Based on OECD Test Guideline 402 Acute Dermal Toxicity: Fixed Dose Procedure it can be
concluded, that the test item Reaction mass of potassium sodium phosphotartrate and potassium
sodium tartrate and potassium sodium ortho-phosphate (aqueous solution) according to the Globally
Harmonised System can be classified in Category 5/Unclassified after single dermal application to
Wistar rats.
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.
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